Silicone Gel-Filled Breast Implant Surgery:

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Silicone Gel-Filled Breast Implant Surgery:

  1. 1. Silicone Gel-Filled BreastImplant Surgery:Making an Informed DecisionAugust 2004 1
  2. 2. Silicone Gel-Filled Breast Implant Surgery:Making an Informed DecisionAugust 2004Table of Contents Page No.Glossary ........................................................................................................................................................................1.0 So You’re Considering Silicone Gel-Filled Breast Implant Surgery .........................................................What Gives the Breast Its Shape? ...............................................................................................................What is a Silicone Gel-Filled Breast Implant? .............................................................................................Are You Eligible for Silicone Gel-Filled Breast Implants? ............................................................................What are Important Factors for You to Consider When Deciding to Have Silicone Gel-Filled Implants? ....Who Is Not Eligible for Breast Implants?......................................................................................................What are Contraindications for You to Consider? ........................................................................................What are Precautions for You to Consider?.................................................................................................What are Warnings for Your Doctor to Consider?........................................................................................What Type of Breast Implants Are Available from Mentor? .........................................................................2.0 What Are Potential Breast Implant Complications? ................................................................................3.0 Mentor’s Clinical Studies........................................................................................................................Description of Studies .................................................................................................................................4.0 Results from the Adjunct Study ..............................................................................................................What were the Follow-up Rates from the Adjunct Study?............................................................................What Were the 5-Year Complication Rates from the Adjunct Study? .........................................................5.0 Augmentation Results from the Core Study ...........................................................................................What were the Follow-up Rates from the Core Study for Augmentation Patients? ......................................What Were the 3-Year Complication Rates from the Core Study for Augmentation Patients? ....................What Were the Types of Additional Surgical Procedures Performed for Augmentation Patients? ..............What Were the Reasons for Implant Removal for Augmentation Patients? ................................................What Were the Breast Disease and CTD Events in Augmentation Patients? ..............................................What Were the Benefits from the Core Study for Augmentation Patients? ..................................................6.0 Breast Augmentation Considerations. .....................................................................................................Special Considerations for Breast Augmentation.........................................................................................What Questions Do You Ask Your Surgeon about Breast Augmentation? .................................................Other Factors to Consider in Breast Augmentation......................................................................................7.0 Reconstruction Results from Core Study ..............................................................................................What Were the Follow-up Rates from the Core Study for Reconstruction Patients? ...................................What Were the 3-Year Complication Rates from the Core Study for Reconstruction Patients? ..................What Were the Types of Additional Surgical Procedures Performed for Reconstruction Patients? .............What Were the Reasons for Implant Removal for Reconstruction Patients? ..............................................What Were the Breast Disease and CTD Events in Reconstruction Patients? ...........................................What Were the Benefits of the Core Study for Reconstruction Patients? ...................................................8.0 Breast Reconstruction Considerations.....................................................................................................Special Considerations for Breast Reconstruction .......................................................................................What Questions Do You Ask Your Surgeon about Breast Reconstruction? ................................................Other Factors to Consider in Breast Reconstruction....................................................................................9.0 Revision Results from Core Study ........................................................................................................What Were the Follow-up Rates from the Core Study for Revision Patients?..............................................What Were the 3-Year Complication Rates from the Core Study for Revision Patients? ............................What Were the Types of Additional Surgical Procedures Performed for Revision Patients? .......................What Were the Reasons for Implant Removal for Revision Patients? ........................................................What Were the Breast Disease and CTD Events in Revision Patients? .....................................................What Were the Benefits of the Core Study for Revision Patients? ..............................................................10.0 Breast Revision Considerations .............................................................................................................Special Considerations for Breast Revision .................................................................................................What Questions Do You Ask Your Surgeon about Breast Revision?...........................................................Other Factors to Consider in Breast Revision ..............................................................................................11.0 Mentor’s Laboratory Testing............................................................................................................................Gel Bleed ......................................................................................................................................................................Damage During Surgery ...............................................................................................................................................12.0 If You Experience a Problem, Should You Report It?............................................................................13.0 Warranty ............................................................................................................................................ 2
  3. 3. 14.0 What Are Other Sources of Additional Information? ............................................................................ GLOSSARYAreola The pigmented or darker colored area of skin surrounding the nipple of the breast.Asymmetry Lack of proportion of shape, size and position between the two breasts.Autoimmune disease A disease in which the body mounts an “attack” response to its own tissues or cell types. Normally, the body’s immune mechanism is able to distinguish clearly between what is a normal substance and what is foreign. In autoimmune diseases, this system becomes defective and produces antibodies against normal parts of the body, causing tissue injury. Certain diseases such as rheumatoid arthritis and scleroderma are considered to be autoimmune diseases.Axillary Pertaining to the armpit area.Bilateral Relating to, or affecting, the right and left breast.Biopsy The removal and examination of tissue, cells or fluid from the body.Breast augmentation A surgical procedure that increases the size and proportions of a woman’s breast.Breast reconstruction A surgical procedure that restores the natural breast contour and mass following mastectomy, trauma, or injury.Capsular contracture A tightening of the scar tissue surrounding an implant, resulting in firmness or hardening of the breast.Capsulectomy Surgical removal of the capsule (scar tissue).Capsulotomy (closed) A breakage in the capsule (scar tissue) by massage or compression on the outside of the breast.Capsulotomy (open) Incision or opening in the capsule (scar tissue) made by an open surgical approach.Carcinoma A malignant (cancerous) tumor.Congenital anomaly A deviation from a normal body part, existing at or dating from birth.Connective tissue A disease or group of diseases affecting connective tissue. The cause of these disease is unknown. The diseases are grouped together on the basis of clinical signs, symptoms, and laboratory abnormalities.Delayed reconstruction Breast reconstruction that takes place weeks, months, or years after a mastectomy.Displacement Movement from the usual or proper place.Epidemiological Relating to the incidence, distribution and control of disease in a population.Extrusion The pressing out of the implant through the surgical wound.Fibrous tissues Connective tissues composed mostly of fibers. 3
  4. 4. Flap A portion of tissue (which may include muscle, fat and skin) with its blood supply moved from one part of the body to another.Hematoma A mass or swelling containing blood.Immune response A bodily response to the presence of a foreign substance.Inframammary Below the breast.Inframammary fold The crease at the base of the breast and the chest wall.Inframammary incision An incision made in the fold below the breast.In-patient surgery A surgical procedure in which the patient is required to stay overnight in thehospital.Latissimus dorsi Two triangular muscles running from the spinal column to the shoulder.MRI Magnetic resonance imagingMammaplasty Plastic surgery of the breast.Mammary Pertaining to the breast.Mammography X-ray examination of the breasts (as for early detection of cancer).Mastectomy The removal of breast tissue due to the presence of a cancerous or precancerous growth. Subcutaneous mastectomy: surgical removal of the breast tissues, but sparing the skin, nipple, and areola. Total mastectomy: surgical removal of the breast including the nipple, areola, and most of the overlying skin. Modified radical mastectomy: surgical removal of the entire breast including the nipple, areola, and overlying skin, as well as the lymphatic-bearing tissue in the axilla. Radical mastectomy: surgical removal of the entire breast including the nipple, areola, and overlying skin, as well as the pectoral muscles, lymphatic bearing tissue in the axilla, and various other neighboring tissue.Mastopexy Plastic surgery to move sagging breasts into a more elevated position.Necrosis Death of living tissue.Oncologist A doctor specializing in the study of tumors.Out-patient surgery A surgical procedure in which the patient is not required to stay in the hospital overnight.Palpate To feel with the hand.Palpability Capability of being touched or felt.Pectoralis Major muscle of the chest.Plastic surgery Surgery intended to repair, restore, or improve the body following trauma, injury, or illness.Prosthesis Any artificial device used to replace or represent a body part. 4
  5. 5. Ptosis Breast sagging that is usually the result of normal aging, pregnancy, or weight loss.Rectus abdominus A long flat muscle extending the whole length of the front of the abdomen (stomach).Rupture Refers to loss of silicone from a silicone-filled breast implant due to a tear or cut in the implant shell.Saline A solution that is made up of water and a small amount of salt. Approximately 70% of an adult’s body weight consists of this salt-water solution.Seroma Accumulation of fluid in tissue.Serratus Muscle located beneath the chest’s pectoralis major and minor muscles and the rib cage.Silicone elastomer A type of silicone that has elastic properties similar to rubber.Silent rupture Refers to rupture that is not recognized or otherwise apparent except through appropriate imaging techniques such as MRISubglandular placement Placement underneath the mammary gland and on top of the chest muscle.Submuscular placement Placement wholly or partially underneath the pectoralis major (chest) muscle.Surgical incision A cut or wound of body tissue made during surgery.Tissue expander An adjustable implant that can be inflated with salt water to stretch the tissue at the mastectomy site to create a new tissue flap for implantation of the breast implant.Transaxillary incision An incision made across the long axis of the armpit.Umbilical Relating to the navel.Unilateral Affecting only one side. 5
  6. 6. SILICONE GEL-FILLED BREAST IMPLANT SURGERY: MAKING AN INFORMED DECISION1.0 So You’re Considering Silicone Gel-Filled Breast Implant SurgeryThe purpose of this brochure is to help you in making an informed decision about breast augmentation(enlargement) and breast reconstruction (restoration) surgery. This educational brochure is set up tohelp you talk with your surgeon, as well as provide you with general information on breast implantsurgery and give you specific details about Mentor silicone gel-filled breast implants.What Gives the Breast Its Shape?The breast consists of milk ducts and glands, surrounded by fattytissue that provides its shape and feel. The pectoralis major muscleor chest muscle is located beneath the breast. Factors such aspregnancy (when milk glands are temporarily enlarged), rapid weightloss, and the effects of gravity as you age, combine to stretch theskin, which may cause the breast to droop or sag.What Is a Silicone Gel-Filled Breast Implant?A breast implant is a sac (implant shell) of silicone elastomer(rubber) filled with silicone gel, which is surgically implanted underyour tissues.Are You Eligible for Silicone Gel-Filled Breast Implants?Implants are to be used for females for the following indications (procedures):• Breast Augmentation —This procedure is done to increase the size and proportionsof a woman’s breasts. A woman must be at least 18 years old for breast augmentation.• Breast Reconstruction —This procedure is done to restore a woman’s breastshape after a mastectomy or injury that resulted in either partial or total loss ofthe breast(s), or to correct a birth defect.• Breast Revision —This procedure is done to correct or improve the result of previous breastsurgery. The revision may involve replacement of a breast implant. 6
  7. 7. What Are Important Factors for You to Consider When Deciding to Have Silicone Gel-Filled Implants?. Whether you are undergoing augmentation or reconstruction, be aware that breast implantation maynot be a one-time surgery. You are likely to need additional surgery and surgeon visits over the courseof your life.. Breast implants are not considered lifetime devices. You will likely undergo implant removal with orwithout replacement over the course of your life.. Many of the changes to your breast following implantation are irreversible (cannot be undone). If youlater choose to have your implant(s) removed, you may experience unacceptable dimpling, puckering,wrinkling, or other cosmetic changes of the breast.. Breast implants may affect your ability to produce milk for breast feeding. Also, breast implants willnot prevent your breasts from sagging after pregnancy.. With breast implants, routine screening mammography will be more difficult, and you will need tohave additional views, which means more time and radiation.. For patients who have undergone breast implantation either as a cosmetic or a reconstructiveprocedure, health insurance premiums may increase, coverage may be dropped (your existinginsurance coverage may not continue), and/or future coverage may be denied (you may not be able toget insurance in the future). Treatment of complications may not be covered as well. You should checkwith your insurance company regarding these coverage issues. You should discuss the completeextent of your insurance coverage before undergoing surgery.Who Is Not Eligible for Breast Implants ?Implants are not to be used for:• Women with existing malignant or pre-malignant cancer of her breast without adequate treatment• Women with active infection anywhere in her body• Augmentation in women who are currently pregnant or nursingWhat are Contraindications for You to Consider?Surgical practices that are contraindicated in breast implantation because they may damage the shell and causerupture• Alteration of the implant• Stacking of implants (more than one implant per breast per breast pocket)What are Precautions for You to Consider?Safety and effectiveness have not been established in patients with the following conditions:• Autoimmune diseases such as lupus and scleroderma• Conditions that interfere with wound healing and blood clotting• A weakened immune system (for example, currently taking drugs that weaken the body’s naturalresistance to disease)• Reduced blood supply to breast tissueFurther considerations:• Pre-implantation Mammography —You may wish to have a preoperativemammogram and another one 6 months to 1 year after implantation to establisha baseline.• Interference with Mammography —The implant may interfere with findingbreast cancer during mammography and also may make it difficult to perform 7
  8. 8. mammography. Therefore, it is essential that you tell your mammography technologistthat you have an implant before the procedure. The technologist canuse special techniques to reduce the possibility of rupture and to get the bestpossible views of the breast tissue. Because the breast is squeezed duringmammography, it is possible for an implant to rupture during the procedure.More x-ray views are necessary with these special techniques; therefore, women with breast implantswill receive more radiation. However, the benefit of the mammogram in finding cancer outweighs therisk of the additional x-rays.• Distinguishing the implant from breast tissue during breast self-examination—You should perform a breast self-examination monthly on your implanted breast. In order to do thiseffectively, you should ask your surgeon to help you tell the difference between the implant and yourbreast tissue. Any new lumps should be evaluated with a biopsy. If a biopsy is performed, care mustbe taken to avoid breaking the implant.• Long-Term Effects —The long-term safety and effectiveness of breast implants have not beenstudied; however, Mentor is monitoring the long-term (i.e., 10 year) chance of implant rupture,reoperation, implant removal, and capsular contracture (hardening of the tissues around the implant).Mentor is also conducting mechanical testing to assess the long-term likelihood of implant rupture.Mentor will update this brochure with this information as it becomes available.• Capsule Procedures —You should be aware that closed capsulotomy, the practice of forciblesqueezing or pressing on the fibrous capsule around the implant to break the scar capsule, is notrecommended, as this may result in breakage of the implant.• Follow-up Examinations – After breast implantation, it is recommended that you have follow-upexaminations by your doctor on an annual or biannual basis.• Rupture – If you suspect that your implant may be ruptured, you should consult your doctor. Ifrupture is confirmed by your doctor, it is recommended that you have your implant removed. Youshould monitor your breast implants for rupture when you check your breasts for lumps monthly.Examine your breast tissue by feeling for lumps. Then feel the breast implants. Move the implantsaround while looking in the mirror. Look for changes in shape, size and feel of the implants. Know,and pay attention to, how the breast implants feel on the inside and well as the outside. If you noticeany changes, see your plastic surgeon so that he or she can examine the implants for rupture or otherchanges.What are Warnings for Your Doctor to Consider?• Closed Capsulotomy – Your doctor should not treat capsular contracture by forceful external compression, which will likely result in implant damage, rupture, folds and/or hematoma.• Reuse – Your doctor should not reuse or resterilize breast implants.• Avoiding Damage During Surgery – Your doctor should take care not to damage the implant with surgical instruments. Your doctor should not use, or attempt to repair, a damaged breast implant. Your doctor should use care during any later procedures to avoid damage to the implant shell. Your doctor should not contact the implant with disposable, capacitor-type cautery devices.• Microwave Diathermy – The use of microwave diathermy (generation of heat in tissue by use of microwaves) is not recommended, as it has been reported to cause tissue necrosis, skin erosion, and extrusion of the implant.• Your doctor should not use endoscopic placement (performed by insertion through an instrument for visualizing the interior of an organ) or the periumbilical (through the belly button) approach in placement of the implant. 8
  9. 9. What Types of Breast Implants Are Available from Mentor?Breast implants come in a variety of shapes, surface textures, and sizes. Breast implants are eithersilicone-filled, saline-filled, or a combination silicone/saline-filled. There are 2 types/families of Mentorimplants filled with saline – one referred to as Saline-Filled and the other referred to as SpectrumTMImplants. The Saline-Filled family of implants has a self-sealing valve located on the front (anterior) ofthe implant that is used for filling the device. The SpectrumTM family has a valve on the back (posterior)of the implant that allows saline to be added after surgery (postoperative adjustability). The implantsare available with Siltex® textured, or smooth surface shells. All currently available Mentor silicone-filled breast implants have either a Siltex textured shell or smooth surface shell.Below is a description of Mentor silicone gel-filled implant styles. Be sure to familiarize yourself withthe different features of breast implants and to discuss the best type(s) of implants for you with yoursurgeon.Catalog Number Silicone Gel-Filled Breast Implant Style Size Range350-7100BC/ Smooth, Round, Moderate Profile 100-800 cc7800BC354-1007/8007 Siltex, Round, Moderate Profile 100-800 cc350-1001BC/ Smooth, Round, Moderate Plus Profile 100-800 cc8001BC354-1001/8001 Siltex, Round, Moderate Plus Profile 100-800 cc350-1254BC/ Smooth, Round, High Profile 125-800 cc8004BC354-1007/8007 Siltex, Round, High Profile 125-800 ccThe following diagrams illustrate the high, moderate plus, and moderate profiles.High Profile Moderate Plus Profile Moderate Profile2.0 What Are Potential Breast Implant Complications?Undergoing any surgical procedure may involve the risk of complications such as the effects ofanesthesia, infection, swelling, redness, bleeding, and pain. In addition, there are potentialcomplications specific to breast implants. 9
  10. 10. These complications include:• RuptureBreast implants rupture when the shell develops a hole or a tear. Implant rupture may or may notresult in the release of silicone gel. Ruptured implants may result in hard knots in the breast, unevenappearance of the breasts, pain or tenderness, tingling, swelling, numbness, burning or changes inbreast sensation. There may be a loss of the size or shape of your breast. However, there may be nosymptoms or loss of the size or shape of your breast (“silent rupture”). Some implants rupture in thefirst few months after being implanted, and some rupture after several years. Causes of ruptureinclude damage by surgical instruments or other trauma during surgery, capsular contracture, closedcapsulotomy, stresses such as trauma or intense physical manipulation (rough treatment with thehands or by mechanical means) after surgery, excessive compression during mammographic imaging,and unknown/unexplained reasons. You should also be aware that the breast implant may wear outover time and rupture.A retrospective (historical) study on rupture of silicone gel-filled breast implants1 was performed inBirmingham, Alabama, and included women who had their first breast implant before 1988. Womenwith silicone-gel filled breast implants had a Magnetic Resonance Imaging (MRI) examination of theirbreasts to determine the status of their current breast implants. The 344 women who received an MRIexamination had a total of 687 implants. Of the 687 implants in the study, at least two of the threestudy radiologists agreed that 378 implants were ruptured (55%). This means that 69% of the 344women had a least one ruptured breast implant. Of the 344 women, 73 (21%) had extracapsularsilicone gel in one or both breasts. Factors that were associated with rupture included increasing ageof the implant, the implant manufacturer, and submuscular rather than subglandular location of theimplant. A summary of the findings of this study is also available on FDA’s website at: • http://www.fda.gov/cdrh/breastimplants/studies/biinterview.pdf • http://www.fda.gov/cdrh/breastimplants/studies/birupture.pdfRobinson et al. studied 300 women who had their implants for 1 to 25 years and had them removed fora variety of reasons2. Visible signs of rupture in 51% of the women studied were found. Severesilicone leakage (silicone outside the implant without visible tears or holes) was seen in another 20%.Robinson et al also noted that the chance of rupture increases as the implant ages. Other studiesindicate that silicone may escape the capsule in 11-23% of rupture cases3,4,5,6.Clinical data from studies of Mentor silicone gel-filled breast implants, along with more recent medicalliterature, suggest that the current models of breast implants rupture less frequently than the earlierimplants that were associated with the high prevalence of rupture described above.Ruptured implants require additional surgery to remove and to possibly replace the implant. Magneticresonance imaging with equipment specifically designed for imaging the breast may be used forevaluating patients with suspected rupture or leakage of their silicone gel-filled breast implant.1 Brown SL, Middleton MS, Berg WA, Soo MS, Penello G. Prevalence of rupture of silicone gel breastimplants in a population of women in Birmingham, Alabama. American Journal of Roentgenology 2000;175:1-8.2 Robinson OG, Bradley EL, Wilson DS. Analysis of explanted silicone implants: a report of 300 patients.Ann Plast Surg. 1995; 34: 1-7.3 Vinnik CA. Migratory silicon – clinical aspects. Silicone in Medical Devices – Conference Proceedings.1991 February 1-2; Baltimore, MD: U.S. Department of Health and Human Services, FDA Publication No.92-4249 (p. 59-67).4 Duffy MJ, Woods JE. Health Risks of failed silicone gel breast implants: a 30-year clinical experience.Plast. Reconstr Surg 1994; 94:295-299.5 Berg WA, Caskey CI, Hamper UM, Kuhlman JE, Anderson ND, Chang BW, Sheth S, Zerhouni EA.Single- and double-lumen silicone breast implant integrity: Prospective evaluation of the MR and UScriteria. Radiology 1995;45-52.6 Gorczyca DP, Schneider E, DeBruhl ND, Foo KTF, Ahn CY, Sayre JW, Shaw WW, Bassett LW. Siliconebreast implant rupture: Comparison between three-point Dixon and fast spin-echo MR imaging. AJR 1994;162:305-310. 10
  11. 11. Silicone gel, which escapes the scar tissue capsule surrounding the implant, may migrate away fromthe breast. The free silicone may cause lumps to form in the breast or other tissues (such as the chestwall, armpit, arm or abdomen). Plastic surgeons usually recommend removal of the implant if it hasruptured, even if the silicone is still enclosed with the capsule, because the silicone gel may eventuallyleak into surrounding tissues. If you are considering removal of an implant and the implantation ofanother one, be sure to discuss the benefits and risks with your doctor.• Capsular ContractureThe scar tissue or capsule that normally forms around the implant may tighten and squeeze theimplant and is called capsular contracture. Capsular contracture may be more common followinginfection, hematoma, and seroma. It is also more common with subglandular placement (behind themammary gland and on top of the chest muscle). Symptoms range from mild firmness and milddiscomfort to severe pain, distorted shape, palpability (ability to be touched or felt) of the implant,and/or movement of the implant.Additional surgery is needed in cases where pain and/or firmness is severe. This surgery ranges fromremoval of the implant capsule tissue to removal and possibly replacement of the implant itself.Capsular contracture may happen again after these additional surgeries.• PainPain of varying intensity and length of time may occur and persist following breast implant surgery. Inaddition, improper size, placement, surgical technique, or capsular contracture may result in painassociated with nerve entrapment or interference with muscle motion. You should tell your surgeonabout severe pain.• Additional SurgeriesYou should know that there is a high chance that you will need to have additional surgery at somepoint to replace or remove the implant. Also, problems such as deflation, capsular contracture,infection, shifting, and calcium deposits can require removal of the implants. Many women decide tohave the implants replaced, but some women do not. If you choose not to, you may have cosmeticallyunacceptable dimpling and/or puckering of the breast following removal of the implant.• Dissatisfaction with Cosmetic ResultsDissatisfying results such as wrinkling, asymmetry, implant displacement (shifting), incorrect size,unanticipated shape, implant palpability (ability to be touched or felt), scar deformity, hypertrophic(irregular, raised scar) scarring, and/or sloshing may occur. Careful surgical planning and techniquecan minimize but not always prevent such results.• InfectionInfection can occur with any surgery. Most infections resulting from surgery appear within a few daysto weeks after the operation. However, infection is possible at any time after surgery. Infections with animplant present are harder to treat than infections in normal body tissues. If an infection does notrespond to antibiotics, the implant may have to be removed, and another implant may be placed afterthe infection is resolved (cleared up).In rare instances, toxic shock syndrome has been noted in women after breast implant surgery, and itis a life-threatening condition. Symptoms include sudden fever, vomiting, diarrhea, fainting, dizziness,and/or sunburn-like rash. A doctor should be seen immediately for diagnosis and treatment for thiscondition.• Hematoma/SeromaHematoma is a collection of blood inside a body cavity, and a seroma is a collection of the wateryportion of the blood (in this case, around the implant or around the cut made during the surgery).Postoperative hematoma and seroma may contribute to infection and/or capsular contracture.Swelling, pain, and bruising may result. If a hematoma occurs, it will usually be soon after surgery.However, this can also occur at any time after injury to the breast. While the body absorbs smallhematomas and seromas, large ones will require the placement of surgical drains for proper healing. Asmall scar can result from surgical draining. Implant deflation/rupture can occur from surgical drainingif damage to the implant occurs during the draining procedure. 11
  12. 12. • Changes in Nipple and Breast SensationFeeling in the nipple and breast can increase or decrease after implant surgery. The range of changesvaries from intense sensitivity to no feeling in the nipple or breast following surgery. Changes in feelingcan be temporary or permanent and may affect your sexual response or your ability to nurse a baby.(See the paragraph on breast feeding below.)• Breast FeedingAt this time it is not known if a small amount of silicone may diffuse (pass through) from the breastimplant silicone shell and may find its way into breast milk. If this occurs, it is not known what effect itmay have on the nursing infant. Although there are no current methods for detecting silicone levels inbreast milk, a study measuring silicon (one component in silicone) levels did not indicate higher levelsin breast milk from women with silicone-filled gel implants when compared to women without implants.With respect to the ability to successfully breast feed after breast implantation, one study reported upto 64% of women with implants who were unable to breast feed compared to 7% without implants. Theperiareolar (located around the colored portion surrounding the nipple) incision site may significantlyreduce the ability to successfully breast feed. The surgical path typically associated with theperiareolar incision passes directly through glandular tissue and would be expected to disrupt ductaltissue important for breast feeding. A modification of this typical periareolar approach that avoidspassing directly through ductal tissue has been suggested as an alternative to reduce the likelihood ofsubsequent breast feeding difficulties.7• Calcium Deposits in the Tissue Around the ImplantDeposits of calcium can be seen on mammograms and can be mistaken for possible cancer, resultingin additional surgery for biopsy and/or removal of the implant to distinguish calcium deposits fromcancer. Calcium deposits also occur in women who undergo breast reduction procedures,8,9,10 and inthe breasts of women who have not undergone any breast surgery (increasing in prevalence with agefrom 8 percent in women 25 to 29 years old up to 86 percent in women 75 to 79 years old.)11• Delayed Wound HealingIn some instances, the incision site takes longer to heal than normally.• ExtrusionUnstable or compromised tissue covering and/or interruption of wound healing may result in extrusion,which is when the breast implant comes through the skin.• NecrosisNecrosis is the formation of dead tissue around the implant. This may prevent wound healing andrequire surgical correction and/or implant removal. Permanent scar deformity may occur followingnecrosis. Factors associated with increased necrosis include infection, use of steroids in the surgicalpocket, smoking, chemotherapy/radiation, and excessive heat or cold therapy.• Breast Tissue Atrophy/Chest Wall DeformityThe pressure of the breast implant may cause the breast tissue to thin and shrink. This can occur whileimplants are still in place or following implant removal without replacement.7 Brody, G.S. 1998. Safety and effectiveness of breast implants. In: Surgery of the Breast: Principals andArt, Ed: Spears, S.: Philadelphia: Lippincott-Raven.8 Abboud, M., J. Vadoud-Seyedi, A. De Mey, M. Cukierfajn, and M. Lejour. 1995. Incidence ofcalcification in the breast after surgical reduction and liposuction. Plast. Reconstr. Surg. 96:620-626.9 Mitnick, J.S., D.F. Roses, M.N. Harris, and S.R. Colen. 1990. Calcifications of the breast after reductionmammoplasty. Surg. Gynecol. Obstet. 171:409-412.10 Brown, F.E., S.K. Sargent, S.R. Cohen, and W.D. Morain. 1987. Mammographic changes followingreduction mammaplasty. Plast. Reconstr. Surg. 80:691-698.11 Stomper, P.C., D.J. D’Souza, P.A. DiNitto, and M.A. Arredondo. 1996. Analysis of parenchymaldensity on mammograms in 1353 women 25-79 years old. Am. J. Roentgenol. 167:1261-1265. 12
  13. 13. Rarer ComplicationsIn addition to these common complications, there have been concerns with rarer diseases, of whichyou should be aware:• Connective Tissue DiseaseConcern over the association of breast implants to the development of autoimmune or connectivetissue diseases and symptoms, such as lupus, scleroderma, or rheumatoid arthritis, was raisedbecause of cases reported in the literature of small numbers of women with implants. A review ofrecent long-term epidemiological studies of women with and without implants,12 together with thereview of a number of previously conducted epidemiological studies,13 indicates that these diseasesand symptoms are no more common in women with implants than those in women without implants.However, a lot of women with breast implants believe that their implants caused a connective tissuedisease.• CancerPublished medical literature14 indicates that:1. Patients with breast implants are not a greater risk than those without breast implants for developing breast cancer;2. Early detection of hidden breast cancer is possible in women with breast implants;3. Submuscular placement of breast implants allows for greater visualization of breast tissue during mammography;4. Mammography exams should be performed and interpreted by radiologists experienced in the evaluation of women with breast implants and should include additional views (i.e., Eklund views using displacement techniques); and5. The current recommendations for getting screening/preoperative mammograms are no different for women with breast implants than for those without implants.6. A recently published review of four large scale incidence studies that included more than 10,000 women with cosmetic implants followed for up to 29 years concluded that, based on these studies, there is no significant excess of brain cancer incidence among women with cosmetic breast implants15.• NeurologicalSome women with breast implants have reported that they have neurological symptoms (such asdifficulties with vision, sensation, muscle strength, walking, balance, thinking or remembering things) ordiseases (such as multiple sclerosis) related to their implants. Several studies have indicated thatwomen with implants are not at an increased risk of being hospitalized with neurological diseasecompared to other women. The IOM report found no basis for thinking that women with implants weremore likely to have neurological diseases or symptoms.• Second Generation EffectsThere have been concerns raised regarding potential damaging effects on children born of motherswith implants. Two large, well-controlled, population-based epidemiological studies (one fromSweden16 and one from Denmark17) have found no evidence to support an association of maternal12 Lipworth, L. R.E. Tarone and J.K. McLaughlin. 2004. Silicone breast implants and connective tissuedisease: An updated review of the epidemiologic evidence. Ann. Plast. Surg. 52:598-601.13 Bondurant, S., V.L. Ernster and R. Herdman, Eds. 2000. Safety of silicone breast implants. Committeeon the Safety of Silicone Breast Implants, Division of Health Promotion and Disease Prevention, Instituteof Medicine. Washington, D.C.:National Academy Press.D. Ramroth and B. Shea. 2001. Do silicone breast implants cause rheumatologic disorders? A systematicreview for a court-appointed national science panel. Arthritis Rheum. 44(11):2477-2484.14 Jakubietz, M.G., J.E. Janis, R.G. Jakubietz and R.J. Rohrich. 2004. Breast augmentation: Cancerconcerns and mammography – A literature review. Plast. Reconstr. Surg. 113:117e-122e.15 McLaughlin, J.K. and L. Lipworth. 2004. Brain cancer and cosmetic breast implants: A review of theepidemiological evidence. Ann. Plast. Surg. 52(2):15-17.16 Signorello, L.B., J.P. Fryzek, W.J. Blot, J.K. McLaughlin and O. Nyren. 2001. Offspring health riskafter cosmetic breast implantation in Sweden. Ann. Plast. Surg. 46:279-286. 13
  14. 14. silicone breast implants and adverse health outcomes in offspring. A review of the published literatureon this issue suggests that the information may be insufficient to draw definitive conclusions.3.0 Mentor’s Clinical StudiesAlthough you will experience your own risks (complications) and benefits following breast implantsurgery, this section describes the specific complications and benefits of Mentor’s gel-filled breastimplants. Mentor’s clinical studies indicate, for example, that while most women can expect toexperience at least one complication at some point through 2 years after implant surgery, most womenwere satisfied with their implants. The studies also indicate that the chance of additional surgery is 1 in8 for augmentation patients (with capsulectomy as the most common type of additional surgery) and 1in 4 for reconstruction patients (with the most common type of additional surgery being implant sizechange). The information below provides more details about the complications and benefits you mayexperience.The long-term safety and effectiveness of breast implants have not been studied; however, Mentor ismonitoring the long-term (i.e., 10 year) chance of implant rupture, reoperation, implant removal, andcapsular contracture (hardening of the tissues around the implant). Mentor is also conductingmechanical testing to assess the long-term likelihood of implant rupture. Mentor will update thisbrochure with this information as it becomes available.Description of StudiesMentor Corporation conducted clinical studies of its silicone gel-filled implants to determine the shortterm and most common complications as well as the benefits of their implants. These were assessedin the following clinical studies: the Core Study and the Adjunct Study.The Core Study was designed as a 10 year study to assess safety and effectiveness in augmentation,reconstruction and revision patients. Patient follow-up was at 6 months, 12 months, 24 months, andannually through 10 years, and is currently on-going. Complications as well as patient satisfaction,breast size change, and measures of body esteem/self esteem/body image were assessed. The CoreStudy consisted of 551 augmentation patients, 251 eligible reconstruction patients, and 205 revisionpatients.The Adjunct Study was designed to assess safety outcomes for a large number of reconstructionpatients at 1, 3 and 5 years, and is on-going. The safety assessment was based on the reportedincidence of capsular contracture, seroma, infection and rupture. The secondary objective of the studywas to provide data concerning potential complications in addition to those reported in the safetyassessment. The Adjunct Study enrolled 48,307 patients (includes primary patients and patients whowere re-implanted with study devices).4.0 Results from Adjunct StudyWhat Were Follow-up Rates from the Adjunct Study?The follow-up rates from the Adjunct Study are shown in the table below.17 Kjoller, K., S. Friis, L.B. Signorello, J.K. McLaughlin, W.J. Blot, L. Lipworth, L. Mellemkjaer, J.F.Winther, and J.H. Olsen. 2002. Health outcomes in offspring of Danish mothers with cosmetic breastimplants. Ann. Plast. Surg. 48:238-245; Kjoller, K., J.K. McLaughlin, S. Friis, W.J. Blot, L. Mellemkjaer,C. Hogsted, J.F. Winther and J.H. Olsen. 1998. Health outcomes in offspring of mothers with breastimplants. Pediatrics 102(5):1112-1115. 14
  15. 15. INDICATION NUMBER YEAR 1 YEAR 3 YEAR 5 ENROLLED FOLLOW-UP FOLLOW-UP FOLLOW-UPReconstruction 13,288 3,614 (34%) 1,301 (19%) 394 (11%)Revision 34,205 9,665 (35%) 3,772 (18%) 1,336 (10%)What Were the 5-Year Complication Rates from the Adjunct Study?The table below shows the 5 year complication rates for reconstruction patients and revision patients.The rates reflect the number of patients out of 100 who experienced the listed complication. Forexample, 16% or 16 out of 100 reconstruction patients experienced capsular contracture at some timewithin 5 years after implantation. However, this does not mean that 16% of the reconstruction patientsstill have capsular contracture at 5 years.Adjunct Study 5-Year Complication Risk RatesComplication Revision Reconstruction N=1,363 N=394Asymmetry 27% 42%Wrinkling 27% 26%Breast Pain 19% 19%Capsular Contracture 18% 16%III /IVExplantation 13% 11%Reoperation 10% 18%Hypertrophic Scarring 6% 9%Irritation/Inflammation 4% 3%Infection 2% 3%Seroma 2% 1%Hematoma 2% 1%Rupture 2% 1%Lymphadenopathy 2% 2%Calcification 2% 1%Delayed Wound Healing 1% 3%Necrosis 1% 2%Extrusion 1% 2%5.0 Augmentation Results from Core StudyWhat Were the Follow-up Rates from the Core Study for Augmentation Patients?Of those patients available to be seen at the 3 year follow-up visit, data are available for 94% of theaugmentation patients.What Were the 3-Year Complication Rates from the Core Study for Augmentation Patients?The 3-year complication rates are shown from the most common to the least common in the table below.The rates reflect the number of augmentation patients out of 100 who experienced the listed complication atleast once within the first 3 years after implantation. Some complications occurred more than once for somepatients. The two most common complications experienced within the first 3 years of implantation werereoperation (15% or 15 patients out of 100) and nipple sensation changes (11% or 11 patients out of 100). 15
  16. 16. 3-Year Complication RateCOMPLICATIONS* N=551 PatientsReoperation 15%Nipple Sensation Changes 11%Capsular Contracture III/IV 8%Hypertrophic Scarring 6%Hematoma 3%Breast Mass 2%Ptosis 2%Breast Pain 2%Breast Sensation Changes 2%Wrinkling 1%Miscarriage 1%Seroma 1%Infection 1%External Injury Not Related to Breast Implants 1%Placement Damage 1%Rash 1%Suture Reaction 1%Rupture <1%Asymmetry <1%Inflammation <1%Granuloma <1%Implant Malposition/Displacement <1%Lymphadenopathy <1%Lactation Difficulties <1%Necrosis <1%New Diagnosis of Rheumatic Disease <1%Other (Non-cosmetic) 3%*Excludes mild occurrences of asymmetry, breast pain, calcification, position change, nipple sensationchanges, breast sensation, nipple complications and wrinkling. 16
  17. 17. What Were the Types of Additional Surgical Procedures Performed for AugmentationPatients?The following table provides a breakdown of the types of additional surgical procedures that were performedthrough the 3 years after the initial implantation. There were 160 additional surgical procedures performed in134 reoperations involving 79 augmentation patients and 115 implants. The most common type ofadditional surgical procedure was capsulectomy (36% of the 160 procedures).TYPE OF ADDITIONAL SURGICAL PERCENTAGEPROCEDURE N=160 ProceduresCapsulectomy 36 (23%)Implant Removal with Replacement 24 (15%)Implant Removal without Replacement 21 (13%)Scar Revision 18 (11%)Capsulotomy 17 (11%)Incision and Drainage 12 (8%)Skin Adjustment 8 (5%)Mastopexy 4 (3%)Biopsy 4 (3%)Capsulorrhaphy 4 (3%)Implant Reposition 4 (3%)Revision of Wound Closure 3 (2%)Implant Pocket Revision 2 (1%)Excise Breast Mass 2 (1%)Nipple Related Procedure (unplanned) 1 (1%)What Were the Reasons for Implant Removal for AugmentationPatients?The main reasons for implant removal among augmentation patients in the Core Study over the 3 years areshown in the table below. There were 45 implants removed in 26 patients. Of these 45 implants, 24 (53%)were replaced. The most common reason for implant removal was patient request (60% of the 45 implantsremoved). PERCENTAGEMAIN REASON FOR IMPLANT REMOVAL N=45 Implants RemovedPatient Request 27 (60%)Capsular Contracture (III and IV) 5 (11%)Breast Pain 2 (4%)Infection 2 (4%)Necrosis 2 (4%)False Positive MRI for Rupture 1 (2%)Wrinkling 1 (2%)Right Implant Removed so Left Implant 1 (2%)Removed AlsoReason Missing 4 (9%) 17
  18. 18. What Were the Breast Disease and CTD Events in Augmentation Patients?Breast disease and connective tissue disease (CTD) were reported in some patients through 3 years afterimplantation in the Core Study. Although there were 551 augmentation patients enrolled in the Core Study,not every patient returned for each follow-up visit. Therefore, the percentage of patients with these eventscannot be determined. Only the number of events can be provided. No new cases of breast cancer werereported in augmentation patients.The table below shows the number of reports of CTD through 3 years after implantation. Some patients mayhave reported more than one CTD. Confirmed reports were based on a diagnosis by a doctor.Rheumatic Disease Augmentation PatientsHashimoto Thyroiditis 1Rheumatoid Arthritis 1Hypothyroiditis 1TOTAL 3Without a comparison group of women with similar characteristics (age, race, etc.) and without breastimplants, no conclusions can be made about the relationship between breast implants and these breastdisease and CTD events.What Were the Benefits from the Core Study for AugmentationPatients?The Core Study measured a variety of outcomes that assessed the benefits of the implants. Foraugmentation, these outcomes included circumferential chest size (the distance around the chest), breastsize change, as well as satisfaction and comfort with appearance. These outcomes were assessed beforeimplantation and at 3 years after surgery for those patients who still had their original implants.For augmentation patients, the average increase in circumferential chest size was 7.1 cm. 370 of the 551patients at 3 years were included in the analysis of cup size. Of these 370 patients, 34% experienced anincrease of one bra cup size, 50% experienced an increase of two bra cup sizes, and 13% experienced anincrease of three bra cup sizes.Ninety seven (97)% of augmentation patients indicated they would have the breast implant surgery again.Among augmentation patients, there was no significant change over two years in the Tennessee Self-Concept Scale and Body Esteem Scale. There was a statistically significant increase in the Rosenberg Self-Esteem Scale, indicating an improvement in self esteem.On the SF-36 Health Survey, at baseline, the overall population scored significantly higher than did thegeneral United States female population on all eight subcategories. The study patients also scoredsignificantly higher than the United States female population on the Mental Component Score (MCS) andPhysical Component Score (PCS). The results for some of the subscales showed scores that decreasedslightly, but statistically significantly, from preoperative to postoperatively, indicating a slight worsening inphysical and mental health. However, the magnitude of these changes was slight, and postoperatively thestudy patients continued to score statistically higher for all eight subcategories and the MCS and PCS ascompared to the United States female population. 18
  19. 19. 6.0 Breast Augmentation ConsiderationsSpecial Considerations for Breast AugmentationWhat Are the Alternatives to Breast Augmentation?• Accept your breasts as they are• Wear a padded bra or external prosthesesYou are advised to wait a week after reviewing and considering the information in this brochure beforedeciding whether to have augmentation surgery.What Questions Do You Ask Your Surgeon about Breast Augmentation?The following list of questions may help to remind you of topics to discuss with your surgeon:1. What are the risks and complications associated with having breast implants?2. How many additional operations on my implanted breast(s) can I expect over my lifetime?3. How will my breasts look if I decide to have the implants removed without replacement?4. What shape, size, surface texturing, incision site, and placement site are recommended for me?5. How will my ability to breast feed be affected?6. How can I expect my implanted breasts to look over time?7. How can I expect my implanted breasts to look after pregnancy? After breast feeding?8. What are my options if I am dissatisfied with the cosmetic outcome of my implanted breasts?9. What alternate procedures or products are available if I choose not to have breast implants?10. Do you have before- and -after photos I can look at for each procedure, and what results are reasonablefor me?Other Factors to Consider In Breast Augmentation• Choosing a SurgeonWhen choosing a surgeon who is experienced with breast augmentation, you should know the answers tothe following questions:1. How many breast augmentation implantation procedures does he/she perform per year?2. How many years has he/she performed breast augmentation procedures?3. Is he/she board certified, and if so, with which board?4. In which states is he/she licensed to practice surgery? Note that some states provide information ondisciplinary action and malpractice claims/settlements to prospective patients either by request or on theWorld Wide Web.5. What is the most common complication he/she encounters with breast augmentation?6. What is his/her reoperation rate with breast augmentation and what is the most common type ofreoperation he/she performs?Familiarize yourself with the following options in breast implant surgery and be preparedto discuss with your surgeon the following issues:• Implant Shape and SizeDepending on the desired shape you wish to achieve, you and your surgeon may choose a round orcontoured implant shape. Generally, the larger you want your cup size, the larger the breast implant thesurgeon will consider (measured in cubic centimeters, or cc’s). You should be aware that contoured implantsthat are placed submuscularly (under your chest muscle) may assume a round shape after implantation.Your surgeon will also evaluate your existing tissue to determine if you have enough to cover the breastimplant. If you desire a breast implant size too large for your tissue, the surgeon may warn you that breastimplant edges may be apparent or visible postoperatively. You may even risk surgical complications. Also,excessively large breast implants may speed up the effects of gravity and result in earlier droop or sag.• Surface TexturingTextured-surface implants were designed to reduce the chance of capsular contracture. Some informationin the literature on small numbers of patients suggests that surface texturing reduces the chance of severecapsular contracture, but clinical information from studies of a large number of women with Mentor implants 19
  20. 20. show no difference in the likelihood of developing capsular contracture with textured implants compared tosmooth-surfaced implants.• PalpabilityThe following may cause implants to be more palpable (more easily felt): textured implants, larger implants,subglandular placement, and the amount of skin/tissue available to cover the implant.• Implant PlacementThe breast implant can be placed either partially under the pectoralis major muscle (submuscular) or on topof the muscle and under the breast glands (subglandular). You should discuss with your surgeon the prosand cons of the implant placement selected for you.The submuscular placement may make surgery last longer,may make recovery longer, may be more painful, and maymake it more difficult to have some reoperation proceduresthan the subglandular placement. The possible benefits of thisplacement are that it may result in less palpable implants, lesscapsular contracture, and easier imaging of the breast withmammography.The subglandular placement may make surgery and recovery shorter, may be less painful, and may beeasier to access for reoperation than the submuscular placement. However, this placement may result inmore palpable implants, more capsular contracture, and more difficult imaging of the breast withmammography.• Incision SitesYou should discuss with your surgeon the pros and cons for the incision site specifically recommended foryou, depending on whether you will be having augmentation or reconstruction.There are 3 common incision sites: under the arm (axillary), around the nipple (periareolar), or within thebreast fold (inframammary). If the incision is made under the arm, the surgeon may use a probe fitted with aminiature camera, along with minimally invasive (very small) instruments, to create a “pocket” for the breastimplant.• Periareolar - This incision is the most concealed, but is associated with a higher likelihood of inability tosuccessfully breast feed, as compared to the other incision sites.• Inframammary - This incision is less concealed than periareolarand associated with less difficulty than the periareolar incisionsite when breast feeding.• Axillary - This incision is less concealed than periareolar andassociated with less difficulty than the periareolar incision sitewhen breast feeding.• Umbilical/endoscopic - This incision site has not been studiedand is not recommended.• Surgical Setting and AnesthesiaAugmentation surgery is usually performed on an outpatientbasis, either in a hospital operating room, surgery center, or 20
  21. 21. surgical suite in the surgeon’s office. General anesthesia is commonly used, and local anesthesia is also anoption. The surgery usually lasts 1 to 2 hours. Your surgeon will make an incision and create a pocket forthe breast implant. Then the breast implant will be placed in the pocket and positioned. Finally, the incisionwill be closed, usually with stitches, and possibly taped.• Postoperative CareYou will probably feel somewhat tired and sore for several days following the operation, and your breastsmay remain swollen and sensitive to physical contact for a month or longer. You may also experience afeeling of tightness in the breast area as your skin adjusts to your new breast size.Postoperative care may involve the use of a postoperative bra, compression bandage, or jog bra for extrasupport and positioning while you heal. At your surgeon’s recommendation, you will most likely be able toreturn to work within a few days, although for at least a couple of weeks you should avoid any strenuousactivities that could raise your pulse and blood pressure. Your surgeon may also recommend breastmassage exercises.Note: If you experience fever, or noticeable swelling and/or redness in your implanted breast(s), you shouldcontact your surgeon immediately.7.0 Reconstruction Results from Core StudyWhat Were the Follow-up Rates from the Core Study for Reconstruction Patients?Of those patients available to be seen at the 3 year follow-up visit, data are available for 95% of thereconstruction patients.What Were the 3-Year Complication Rates from the Core Study forReconstruction Patients?The 3-year complication rates (including all levels of severity, from mild to severe) are shown from the mostcommon to the least common in the table below. The rates reflect the number of reconstruction patients outof 100 who experienced the listed complication at least once within the first 3 years after implantation. Somecomplications occurred more than once for some patients. The two most common complicationsexperienced within the first 3 years of implantation were reoperation (26% or 26 patients out of 100) andcapsular contracture (9% or 9 patients out of 100). 21
  22. 22. 3 Year Complication RateCOMPLICATION* N=251Reoperation 26%Capsular Contracture III/IV 9%Asymmetry 7%Ptosis 7%Hypertrophic Scarring 6%Infection 5%Seroma 5%Breast Mass 4%Wrinkling 3%Nipple Sensation Changes 3%Breast Pain 2%Metastatic Disease 2%Lymphadenopathy 2%Implant Malposition/Displacement 2%Recurrent Breast Cancer 2%Hematoma 2%Necrosis 1%Rupture 1%Extrusion 1%Miscarriage 1%Breast Sensation Changes 1%Rash <1%New Diagnosis of Rheumatic Disease <1%External Injury Not Related to Breast <1%ImplantsDelayed Wound Healing <1%Other (Non-cosmetic) 8%*Excludes mild occurrences of asymmetry, breast pain, calcification, position change, nipple sensationchanges, breast sensation, nipple complications and wrinkling. 22
  23. 23. What Were the Types of Additional Surgical Procedures Performed for ReconstructionPatients?The following table provides a breakdown of the types of additional surgical procedures that were performedthrough the 3 years after the initial implantation. There were 139 additional surgical procedures performed in95 reoperations involving 64 reconstruction patients and 82 implants. The most common type of additionalsurgical procedure was implant removal with replacement (17% of the 139 procedures).TYPE OF ADDITIONAL SURGICAL PERCENTAGEPROCEDURE N=139 ProceduresImplant Removal (With Replacement) 23 (17%)Implant Reposition 17 (12%)Implant Removal (without Replacement) 17 (12%)Capsulotomy 14 (10%)Skin Adjustment 14 (10%)Capsulectomy 10 (7%)Biopsy 10 (7%)Scar Revision 7 (5%)Implant Pocket Revision 6 (4%)Mastopexy 4 (3%)Incision and Drainage 4 (3%)Nipple Related Procedure (unplanned) 2 (1%)Removal of Nodule on Chest Wall 2 (1%)Capsulorrhaphy 2 (1%)Create Inframammary Fold 2 (1%)Revision of Breast/External to Pocket 2 (1%)Revision of Wound Closure 1 (1%)Flap Coverage of Expander 1 (1%)Breast Mass Excision 1 (1%)What Were the Reasons for Implant Removal for Reconstruction Patients?The main reasons for implant removal among reconstruction patients in the Core Study over the 3 years areshown in the table below. There were 40 implants removed in 31 patients. Of the 40 implants removedamong reconstruction patients, 23 (58%) were replaced. The most common reason for implant removal waspatient request (33% of the 40 implants removed). PERCENTAGEMAIN REASON FOR IMPLANT REMOVAL N=40 Implants RemovedPatient Request 13 (33%)Asymmetry 10 (25%)Capsular Contracture III/IV 4 (10%)Implant Reposition 3 (8%)Implant too Large 2 (5%)Infection 2 (5%)Extrusion 2 (5%)Hematoma 1 (3%)Lack of Projection 1 (3%)Muscle Spasm 1 (3%)Recurrent Breast Cancer 1 (3%) 23
  24. 24. What Were the Breast Disease and CTD Events in Reconstruction Patients?Breast disease and connective tissue disease (CTD) were reported in some patients through 3 years afterimplantation in the Core Study. Although there were 251 reconstruction patients enrolled in the Core Study,not every patient returned for each follow-up visit. Therefore, the percentage of patients with these eventscannot be determined. Only the number of events can be provided. There was a new diagnosis of breastcancer in one reconstruction patient.The table below shows the number of reports of CTD through 3 years after implantation. Some patients mayhave reported more than one CTD. Confirmed reports were based on a diagnosis by a doctor.Rheumatic Disease Reconstruction PatientsFibromyalgia 1TOTAL 1Without a comparison group of women with similar characteristics (age, race, etc.) and without breastimplants, no conclusions can be made about the relationship between breast implants and these CTDevents.What Were the Benefits of the Core Study for Reconstruction Patients?The Core Study measured a variety of outcomes that assessed the benefits of the implants. Forreconstruction, these outcomes included circumferential chest size, as well as satisfaction and comfort withappearance. These outcomes were assessed before implantation and at 3 years after surgery for thosepatients who still had their original implants.For reconstruction patients (includes delayed post-mastectomy patients only), the average increase incircumferential chest size was 3.3 cm.Ninety eight (98)% of reconstruction patients indicated they would have the breast implant surgery again.Among reconstruction patients, there was no significant change over two years in the Tennessee Self-Concept Scale, Rosenberg Self Esteem Scale and Body Esteem Scale.On the SF-36 Health Survey, at baseline, the overall population scored significantly higher than did thegeneral United States female population on all eight subcategories. The study patients also scoredsignificantly higher than the United States female population on the Mental Component Score (MCS) andPhysical Component Score (PCS). The results for some of the subscales showed scores that decreasedslightly, but statistically significantly, from preoperative to postoperatively, indicating a slight worsening inphysical and mental health. However, the magnitude of these changes was slight, and postoperatively thestudy patients continued to score statistically higher for all eight subcategories and the MCS and PCS ascompared to the United States female population. 24
  25. 25. 8.0 Breast Reconstruction ConsiderationsSpecial Considerations for Breast ReconstructionShould You Have Breast Reconstruction?Whether you decide to have breast reconstruction depends on your own individual case, medical condition,general health, lifestyle, emotional state, and breast size and shape. You may consider consulting yourfamily, friends, breast implant support groups, and breast cancer support groups to help you in making thisdecision.If you are considering breast reconstruction and do not have a plastic surgeon, ask your general surgeon fora referral for the names of experienced, board-certified plastic surgeons in your area. Your general surgeon,plastic surgeon, and oncologist should work together to plan your mastectomy and reconstruction procedureto give you the best possible result.What Are the Alternatives to Breast Reconstruction?You may choose not to undergo breast reconstruction. In this case, you may or may not decide to wear anexternal breast form (prosthesis) inside your bra. Breast forms are available in a variety of shapes, sizes,and materials such as foam, cotton, and silicone. Custom prostheses are also available to match the sizeand shape of your breast.What Are the Choices in Reconstructive Procedures?The type of breast reconstruction procedure available to you depends on your medical situation, breastshape and size, general health, lifestyle, and goals. Women with small or medium-sized breasts are the bestcandidates for breast reconstruction.Breast reconstruction can be accomplished by the use of a prosthesis (a breast implant, either silicone gel orsaline-filled), your own tissues (a tissue flap), or a combination of the two. A tissue flap is a section of skin,fat, and/or muscle which is moved from your stomach, back, or other area of your body to the chest area,and shaped into a new breast.Whether or not you have reconstruction with or without breast implants, you will probably undergo additionalsurgeries to improve symmetry and appearance. For example, because the nipple and areola are usuallyremoved with the breast tissue in mastectomy, the nipple is usually reconstructed by using a skin graft fromanother area of the body or the opposite breast in addition to tattooing the area. Nipple reconstruction isusually done as a separate outpatient procedure after the initial reconstruction surgery is complete.Breast Reconstruction with Breast ImplantsYour surgeon will decide whether your health and medical condition make you an appropriate candidate forbreast implant reconstruction. Women with larger breasts may require reconstruction with a combination of atissue flap and an implant. Your surgeon may recommend breast implantation of the opposite, uninvolvedbreast in order to make them more alike (maximize symmetry) or he/she may suggest breast reduction(reduction mammoplasty) or a breast lift (mastopexy) to improve symmetry. Mastopexy involves removing astrip of skin from under the breast or around the nipple and using it to lift and tighten the skin over thebreast. Reduction mammoplasty involves removal of breast tissue and skin. If it is important to you not toalter the unaffected breast, you should discuss this with your surgeon, as it may affect the breastreconstruction methods considered for your case.Reconstruction Incision SitesMost implants in breast reconstruction use the mastectomy scar either immediately (during the tissueexpansion procedure) or after tissue expansion.Surgical Settings and AnesthesiaReconstruction surgery is usually performed on an inpatient basis in an operating room. General anesthesiais most often used.The Timing of Your Breast Implant ReconstructionThe following description applies to reconstruction following mastectomy, but similar considerations apply toreconstruction following breast trauma or reconstruction for congenital defects. The breast reconstruction 25
  26. 26. process may begin at the time of your mastectomy (immediate reconstruction) or weeks to years afterwards(delayed reconstruction). Immediate reconstruction may involve placement of a breast implant, but typicallyinvolves placement of a tissue expander, which will eventually be replaced with a breast implant. It isimportant to know that any type of surgical breast reconstruction may take several steps to complete.Two potential advantages to immediate reconstruction are that your breast reconstruction starts at the timeof your mastectomy and that there may be cost savings in combining the mastectomy procedure with thefirst stage of the reconstruction. However, there may be a higher risk of complications such as deflation withimmediate reconstruction, and your initial operative time and recuperative time may be longer.A potential advantage to delayed reconstruction is that you can delay your reconstruction decision andsurgery until other treatments, such as radiation therapy and chemotherapy, are completed. Delayedreconstruction may be advisable if your surgeon anticipates healing problems with your mastectomy, or ifyou just need more time to consider your options.There are medical, financial, and emotional considerations to choosing immediate versus delayedreconstruction. You should discuss with your surgeon, plastic surgeon, and oncologist the pros and cons ofthe options available in your individual case.Surgical Considerations to Discuss with Your SurgeonDiscuss the advantages and disadvantages of the following options with your surgeon and your oncologist:• Immediate Reconstruction:One-stage immediate reconstruction with a breast implant (implant only).Two-stage immediate reconstruction with a tissue expander, followed by delayed reconstruction severalmonths later with a breast implant.• Delayed Reconstruction:Two-stage delayed reconstruction with a tissue expander, followed several months later by replacement witha breast implant.What Is the Breast Implant Reconstruction Procedure?• One-Stage Immediate Breast Implant ReconstructionImmediate one-stage breast reconstruction may be done at the time of your mastectomy. After the generalsurgeon removes your breast tissue, the plastic surgeon will then implant a breast implant that completesthe one-stage reconstruction. In reconstruction following mastectomy, a breast implant is most often placedsubmuscularly.• Two-Stage (Immediate or Delayed) Breast Implant ReconstructionBreast reconstruction usually occurs as a two-stage procedure, starting with the placement of a breast tissueexpander, which is replaced several months later with a breast implant. The tissue expander placement maybe done immediately, at the time of your mastectomy, or be delayed until months or years later.Stage 1: Tissue ExpansionDuring a mastectomy, the general surgeon removes skin as well as breast tissue, leaving the chest tissuesflat and tight. To create a breast-shaped space for the breast implant, a tissue expander is placed under theremaining chest tissues. 26
  27. 27. The tissue expander is a balloon-like device made from elastic silicone rubber. It is inserted unfilled, andover time, sterile saline fluid is added by inserting a small needle through the skin to the filling port of thedevice. The filling port or injection dome can be integral (part of the tissue expander itself) or remote(separate from the tissue expander). As the tissue expander fills, the tissues over the expander begin tostretch, similar to the gradual expansion of a woman’s abdomen during pregnancy. The tissue expandercreates a new breast-shaped pocket for a breast implant.Tissue expander placement usually occurs under general anesthesia in an operating room. Operative time isgenerally 1 to 2 hours. The procedure may require a brief hospital stay, or be done on an outpatient basis.Typically, you can resume normal daily activity after 2 to 3 weeks.Because the chest skin is usually numb from the mastectomy surgery, it is possible that you may notexperience pain from the placement of the tissue expander. However, you may experience feelings ofpressure, tightness, and discomfort after each filling of the expander, which subsides as the tissue expandsbut may last for a week or more. Tissue expansion typically lasts 4 to 6 months.Stage 2: Placing the Breast ImplantAfter the tissue expander is removed, the unfilled breast implant is placed in the pocket, and then filled withsterile saline fluid. In reconstruction following mastectomy, a breast implant is most often placedsubmuscularly. The surgery to replace the tissue expander with a breast implant (implant exchange) isusually done under general anesthesia in an operating room. It may require a brief hospital stay or be doneon an outpatient basis.Breast Reconstruction Without Implants: Tissue Flap ProceduresThe breast can be reconstructed by surgically moving a section of skin, fat, and muscle from one area ofyour body to another. The section of tissue may be taken from such areas as your abdomen, upper back,upper hip, or buttocks.The tissue flap may be left attached to the blood supply and moved to the breast area through a tunnelunder the skin (a pedicled flap), or it may be removed completely and reattached to the breast area bymicrosurgical techniques (a free flap). Operating time is generally longer with free flaps because of themicrosurgical requirements.Flap surgery requires a hospital stay of several days and generally a longer recovery time than implantreconstruction. Flap surgery also creates scars at the site where the flap was taken and on thereconstructed breast. However, flap surgery has the advantage of being able to replace tissue in the chestarea. This may be useful when the chest tissues have been damaged and are not suitable for tissueexpansion. Another advantage of flap procedures over implantation is that alteration of the unaffected breastis generally not needed to improve symmetry.The most common types of tissue flaps are the TRAM (transverse rectus abdominus musculocutaneousflap) (which uses tissue from the abdomen) and the Latissimus Dorsi flap (which uses tissue from the upperback). 27
  28. 28. It is important for you to be aware that flap surgery, particularly the TRAM flap, is a major operation, andmore extensive than your mastectomy operation. It requires good general health and strong emotionalmotivation. If you are very overweight, smoke cigarettes, have had previous surgery at the flap site, or haveany circulatory problems, you may not be a good candidate for a tissue flap procedure. Also, if you are verythin, you may not have enough tissue in your abdomen or back to create a breast mound with this method.The TRAM Flap (Pedicle or Free)During a TRAM flap procedure, the surgeon removes a section of tissue from your abdomen and moves it toyour chest to reconstruct the breast. The TRAM flap is sometimes referred to as a “tummy tuck”reconstruction, because it may leave the stomach area flatter.A pedicle TRAM flap procedure typically takes 3 to 6 hours of surgery under general anesthesia; a freeTRAM flap procedure generally takes longer. The TRAM procedure may require a blood transfusion.Typically, the hospital stay is 2 to 5 days. You can resume normal daily activity after 6 to 8 weeks. Somewomen, however, report that it takes up to 1 year to resume a normal lifestyle. You may have temporary orpermanent muscle weakness in the abdominal area. If you are considering pregnancy after yourreconstruction, you should discuss this with your surgeon. You will have a large scar on your abdomen andmay also have additional scars on your reconstructed breast. 28
  29. 29. The Latissimus Dorsi Flap With or Without Breast ImplantsDuring a Latissimus Dorsi flap procedure, the surgeon moves a section of tissue from your back to yourchest to reconstruct the breast. Because the Latissimus Dorsi flap is usually thinner and smaller than theTRAM flap, this procedure may be more appropriate for reconstructing a smaller breast.The Latissimus Dorsi flap procedure typically takes 2 to 4 hours of surgery under general anesthesia.Typically, the hospital stay is 2 to 3 days. You can resume daily activity after 2 to 3 weeks. You may havesome temporary or permanent muscle weakness and difficulty with movement in your back and shoulder.You will have a scar on your back, which can usually be hidden in the bra line. You may also have additionalscars on your reconstructed breast.• Postoperative CareDepending on the type of surgery you have (i.e., immediate or delayed), the postoperative recovery periodwill vary.Note: If you experience fever, or noticeable swelling and/or redness in your implanted breast(s), you shouldcontact your surgeon immediately.What Questions Do You Ask Your Surgeon about Breast Reconstruction?The following list of questions may help to remind you of topics to discuss with your surgeon:1. What are all my options for breast reconstruction?2. What are the risks and complications of each type of breast reconstruction surgery, and how common arethey?3. What if my cancer recurs or occurs in the other breast?4. Will reconstruction interfere with my cancer treatment?5. How many steps are there in each procedure, and what are they?6. How long will it take to complete my reconstruction?7. How much experience do you have with each procedure?8. Do you have before- and- after photos I can look at for each procedure, and what results are reasonablefor me?9. What will my scars look like?10. What kind of changes in my implanted breast can I expect over time?11. What kind of changes in my implanted breast can I expect with pregnancy?12. What are my options if I am dissatisfied with the cosmetic outcome of my implanted breast?13. Can I talk with other patients about their experiences?14. For staged reconstruction, what is the estimated total cost of each procedure?15. How much will my health insurance carrier cover, especially any complication that may require surgery? 29
  30. 30. 16. How much pain or discomfort will I feel, and for how long?17. How long will I be in the hospital?18. Will I need blood transfusions, and can I donate my own blood?19. When will I be able to resume my normal activity (sexual activity or athletic activity)?Other Factors to Consider In Breast Reconstruction• Choosing a SurgeonWhen choosing a surgeon who is experienced with breast reconstruction, you should know the answers tothe following questions:1. How many breast reconstruction implantation procedures does he/she perform per year?2. How many years has he/she performed breast reconstruction procedures?3. Is he/she board certified, and if so, with which board?4. In which states is he/she licensed to practice surgery? Note that some states provide information ondisciplinary action and malpractice claims/settlements to prospective patients either by request or on theWorld Wide Web.5. What is the most common complication he/she encounters with breast reconstruction?6. What is his/her reoperation rate with breast reconstruction and what is the most common type ofreoperation he/she performs?Familiarize yourself with the following options in breast implant surgery and be prepared to discuss with yoursurgeon the following issues:• Implant Shape and SizeDepending on the desired shape you wish to achieve, you and your surgeon may choose a round orcontoured implant shape. Generally, the larger you want your cup size, the larger the breast implant thesurgeon will consider (measured in cubic centimeters, or cc’s).Your surgeon will also evaluate your existing tissue to determine if you have enough to cover the breastimplant. If you desire a breast implant size too large for your tissue, the surgeon may warn you that breastimplant edges may be apparent or visible postoperatively. You may even risk surgical complications. Also,excessively large breast implants may speed up the effects of gravity and result in earlier droop or sag.• Surface TexturingTextured-surface implants were designed to reduce the chance of capsular contracture. Some informationin the literature on small numbers of patients suggests that surface texturing reduces the chance of severecapsular contracture, but clinical information from studies of a large number of women with Mentor implantsshows no difference in the likelihood of developing capsular contracture with textured implants compared tosmooth-surfaced implants.• PalpabilityThe following may cause implants to be more palpable (more easily felt): textured implants, larger implants,subglandular placement, and the amount of skin/tissue available to cover the implant.• InsuranceMost insurance covers the first breast reconstruction operation. Insurance coverage for reoperationprocedures or additional surgeon’s visits following reconstruction may not be covered, depending on thepolicy. 30
  31. 31. 9.0 Revision Results from Core StudyWhat Were the Follow-up Rates from the Core Study for Revision Patients?Of those patients available to be seen at the 3 year follow-up visit, data are available for 93% of therevision patients.What Were the 3-Year Complication Rates from the Core Study for Revision Patients?The 3-year complication rates are shown from the most common to the least common in the table below.The rates reflect the number of revision patients out of 100 who experienced the listed complication at leastonce within the first 3 years after implantation. Some complications occurred more than once for somepatients. The two most common complications experienced within the first 3 years of implantation werereoperation (26% or 26 patients out of 100) and capsular contracture (17% or 17 patients out of 100). 31
  32. 32. PERCENTAGECOMPLICATION* N=205Reoperation 26%Capsular Contracture III/IV 17%Nipple Sensation Changes 9%Hypertrophic Scarring 6%Breast Mass 6%Asymmetry 3%Implant Malposition/Displacement 3%Hematoma 3%Rupture 2%Wrinkling 2%Ptosis 2%Delayed Wound Healling 2%Breast Pain 2%Breast Sensation Changes 2%Seroma 2%Inflammation 1%External Injury Not Related to Breast 1%ImplantsExtrusion 1%Infection 1%Lactation Difficulties 1%Inflammation 1%New Diagnosis of Breast Cancer 1%New Diagnosis of Rheumatic Disease 1%Granuloma 1%Recurrent Breast Cancer 1%Other (Non-cosmetic) 6%*Excludes mild occurrences of asymmetry, breast pain, calcification, position change, nipple sensitivity(unacceptably low), breast sensitivity (unacceptably low and unacceptably high), nipple complications andwrinkling. 32

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