Things toConsider BeforeYour SiliconeImplant SurgeryINTRODUCTION      Cosmetic or “plastic” surgery thatplaces (implants) ...
package insert or this summary preparedby the California Department of HealthServices and published and distributedby the ...
to olive oil in thickness. Silicone fluidis widely used as a lubricant in medicaland food preparation equipment. Sili-cone...
Two surgeons first used siliconerubber for plastic surgery for cosmeticpurposes in 1961. In 1962, the firstsilicone rubber...
included in this premarket approval cat-egory but were allowed to stay on themarket as “grandfathered” devices sincethey h...
response to these reports. In April 1991FDA asked manufacturers of siliconegel-filled breast implants to submit sci-entifi...
entific data to prove the safety and effec-tiveness of these implants. FDA has notyet set a deadline for submission of thi...
health. One such study reported a slightlyincreased risk of connective tissue diseasein women with breast implants.Henneke...
RISKS ASSOCIATED WITHSILICONE BREASTIMPLANTS      Many women have had siliconebreast implant surgery with few or noproblem...
KNOWN RISKS OFSILICONE BREASTIMPLANTSSurgical Risks     Possible complications of general an-        esthesia, including n...
Temporary or permanent change or loss    of sensation in the nipple or breast    tissue. Formation of calcium deposits in ...
ness or burning; nausea or vomit-        ing; and irritable bowel syndrome.     Fibrositis/fibromyalgia-like disorders —  ...
The implant risks described for sili-cone breast implants apply to silicone im-plants generally. Implants in areas otherth...
Risks of Silicone PenileImplants     Failure of the implant to function as        intended     Sizing errors     Infection...
WHERE CAN I GET MOREINFORMATION?     The best source of informationabout your implant surgery is your doc-tor. He or she k...
State of CaliforniaDepartment of Health Services714/744 P StreetP.O.Box 942732Sacramento, CA 94234-7320
Things ToConsider Before  YourSiliconeImplantSurgery State of CaliforniaDepartment ofHealth Services    April 1999
The information in this booklet iscurrent as of the date of printing.It was developed by the State ofCalifornia, Departmen...
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Things to Consider Before Your Silicone Implant Surgery

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Things to Consider Before Your Silicone Implant Surgery

  1. 1. Things toConsider BeforeYour SiliconeImplant SurgeryINTRODUCTION Cosmetic or “plastic” surgery thatplaces (implants) various types ofsilicone plastic into the human body hasbecome very popular over the past twodecades. In the early 1990s, the publicbecame concerned over widespreadpress reports that silicone may causeharmful side effects, chronic disease,and possibly even fatal complications. The California Legislature re-sponded to this concern by passing theCosmetic Implant Act of 1992. This lawrequires doctors to give written infor-mation to patients considering siliconeimplant surgery. The written informa-tion may be the manufacturer’s patient 1
  2. 2. package insert or this summary preparedby the California Department of HealthServices and published and distributedby the Medical Board of California. This summary will help you betterunderstand the risks of silicone implants.The State of California does not endorseany particular procedure nor does thisbrochure claim to provide an exhaus-tive analysis of all the potential ben-efits or risks associated with anyparticular procedure. Individuals mustevaluate these for themselves with thehelp of their doctors. You will gain the most from thisbrochure by reading it thoroughly andthen discussing any questions you mayhave with your doctor before makingyour decision for silicone implant sur-gery.What is silicone? Silicone is a chemical made fromthe naturally occurring elements silicon,oxygen and hydrogen. Silicon is oneof the most common elements on earth.It is usually found in quartz rock or or-dinary white sand. Silicon found inquartz rock and white sand is called sili-con dioxide because it is combined withoxygen from the air. Silicone is manu-factured by chemically combining sili-con dioxide from white sand, carbonfrom carbon dioxide, and the gases hy-drogen and oxygen. After many stepssilicone fluid is produced. Silicone fluid is clear and is similar2
  3. 3. to olive oil in thickness. Silicone fluidis widely used as a lubricant in medicaland food preparation equipment. Sili-cone fluid can be made into siliconerubber or thickened into silicone gel.Many additional processing and testingsteps are performed before silicone canbe used for medical purposes. Theseinclude steps to assure purity, andtesting to help assure that the materialwill not harm living tissue that it touches.This is known as biocompatability.Silicone rubber produced for medicalpurposes is molded into many formsincluding blocks, tubes or sheets usedto make silicone implants. Silicone gelproduced for medical purposes is usedto fill hollow silicone implants to givethe feel of soft body parts. It is alsoused directly in some eye surgeries.What are the MedicalUses of Silicone? There are many medical uses ofsilicone gel and silicone rubber. Thefirst silicone implant was a small tubeused to drain excess fluid surroundingthe brain into the blood stream. Over500,000 of these tubes have been usedsince 1955. More recently, medical grade sili-cones have been used for bone im-plants, coatings for heart pacemakers,drain tubes for surgical wounds, tubesused to enter the blood stream or uri-nary tract, replacement lenses withinthe eye, and many other medical appli-cations. 3
  4. 4. Two surgeons first used siliconerubber for plastic surgery for cosmeticpurposes in 1961. In 1962, the firstsilicone rubber breast implant was com-mercially developed. Since that time,silicone rubber implants, some with asilicone gel filling, have also been de-veloped for the calf muscles, chestmuscles, facial bones, penis, testicle,nose and ear. Silicone implants may be used forcosmetic purposes or for reconstructionafter injury or illness (such as breast ortesticular cancer). Silicone breastimplant surgery has been the most fre-quently performed silicone implant sur-gery. The federal Food and Drug Ad-ministration (FDA) estimates that ap-proximately 2 million American womennow have breast implants.What Is Being Done toEvaluate the Safety ofSilicone Implants? In 1976 Congress passed the firstlaw requiring FDA to regulate the manu-facture and marketing approval of medi-cal devices, including silicone implants.A major protection provided by this lawwas that certain devices would requireFDA’s premarket approval before theycould be sold. That is, manufacturerswould have to provide FDA scientificevidence of safety and effectivenessbefore FDA would approve them formarketing. Devices such as the siliconerubber and gel cosmetic implants were4
  5. 5. included in this premarket approval cat-egory but were allowed to stay on themarket as “grandfathered” devices sincethey had been in commercial distribu-tion before the law was passed. Thenew law said that the manufacturers ofthese devices would eventually haveto provide FDA with scientific data toshow that the devices are safe and ef-fective. Many research studies have beendone since the early 1950’s to deter-mine the safety of silicone for medicaluses. These included studying the ef-fects of silicone materials implanted intoanimals, and laboratory tests specificallydesigned to evaluate the safety of ma-terials intended to contact human tis-sues. These studies were able toidentify very few negative effectsassociated with silicone as a surgicalimplant material. Silicone implant sur-geries were performed routinely. As silicone implant usage increasedso did the number of adverse reactionreports. Between 1985 and September17, 1996 FDA received 103,343 adversereaction reports associated with siliconebreast implants with silicone gel filler,and another 23,454 associated with sili-cone breast implants with saline (saltwater) filler. FDA does not know whatthe actual rate of adverse reaction reportsis (i.e., the percentage of implantrecipients who have reported adversereactions) because it does not have theauthority to require manufacturers toprovide them information about the ac-tual number of patients who have re-ceived implants. Nevertheless, there was concernthat these may be more than should beexpected. FDA took several actions in 5
  6. 6. response to these reports. In April 1991FDA asked manufacturers of siliconegel-filled breast implants to submit sci-entific data showing safety and effec-tiveness. The data submitted was notenough for FDA to conclude that thedevices were safe and effective. So, inApril 1992, FDA removed silicone gel-filled breast implants from the marketexcept for:• use in controlled clinical studies for reconstruction after mastectomy,• correction of congenital deformities,• or replacement of ruptured silicone gel-filled implants for augmen- tation. The purpose of the studies is togather additional scientific data to evalu-ate the safety and effectiveness of gel-filledimplants for these purposes. Data fromcompleted studies may then be used tosupport an application to FDA for per-mission to resume general marketing ofgel-filled implants for these purposes. In order to conduct the studies,manufacturers of gel-filled implants mustask FDA for an investigational deviceexemption (IDE). FDA will not considerIDE applications for breastaugmentation. Patients who choose toreceive silicone gel-filled implants aspart of these scientific studies must beadvised of all known and possible risksand sign a consent form to participatein the study. Study participants will beclosely monitored for adverse reactions. FDA also is requiring manufactur-ers of saline-filled implants to submit sci-6
  7. 7. entific data to prove the safety and effec-tiveness of these implants. FDA has notyet set a deadline for submission of thisdata. In the interim, FDA is allowing sa-line-filled implants to remain on the mar-ket for use in both cosmetic and recon-structive surgery. This is because FDAconsiders saline-filled implants less risky. Although they have the same siliconerubber envelope as gel-filled implants,leakage or rupture would release only saltwater, not silicone gel, into the body.Manufacturers of saline-filled implantsmust provide written information on theknown and possible risks of their prod-ucts and implant recipients must sign aconsent form. Concerns about implant safety havecaused health researchers to conductstudies as well. Some studies involvethe review of large numbers of medicalrecords to see if persons with implantsexperience an abnormally high level ofhealth problems compared to personswithout implants. Two recent studies, the HarvardNurses’ Health Study and a Mayo Clinicstudy compared the rates of immune-related diseases in women with salineand gel-filled implants to those withoutimplants. These and other similar studieswere not able to identify an increasedrisk of these types of diseases for implantrecipients. A limitation of these types ofstudies is that they are not able to detectvery small increases in risk A different type of study involvesasking people questions about their 7
  8. 8. health. One such study reported a slightlyincreased risk of connective tissue diseasein women with breast implants.Hennekens and co-workers at HarvardUniversity evaluated the responses of al-most 400,000 (nearly 11,000 with gel-filled or saline implants) women to a ques-tionnaire. They found that over a 10-yearperiod women with breast implants were1.24 times more likely to report havingsome type of connective tissue disease thanwomen without breast implants. This applies to all of the connectivetissue diseases considered together. Whencalculated individually, the increased riskof each of these diseases was not statisti-cally significant. This study was limitedin its design because self-reported diseasewas not confirmed by medical records, thestudy cannot differentiate between the riskof saline and gel-filled implants, and notall women asked to participate completedthe questionnaire. For these and otherreasons, the actual risk may be differentthan that reported by the study.8
  9. 9. RISKS ASSOCIATED WITHSILICONE BREASTIMPLANTS Many women have had siliconebreast implant surgery with few or noproblems. But some women who havehad silicone breast implant surgery havehad problems. Anyone considering sili-cone breast implant surgery should knowthat there is a risk that they may haveproblems too. FDA describes the risksof silicone breast implant surgery asbeing either “known” or “possible.” Known risks are those that, whenthey occur, can be attributed to thesurgery or the implant itself. Possiblerisks are problems that women havehad, but that cannot necessarily beattributed to the implants. This is be-cause, after looking at all availablescientific information, FDA scientistsfound that women with implants do nothave a significantly higher rate of theseproblems than women without implants. But scientific studies are not alwaysable to detect small but important in-creases in risk. So silicone breastimplants cannot be ruled out as a pos-sible risk factor for these types of prob-lems. This is why FDA describes themas possible risks, and requires that po-tential implant recipients be informedof these possible, although unlikely, risks. 9
  10. 10. KNOWN RISKS OFSILICONE BREASTIMPLANTSSurgical Risks Possible complications of general an- esthesia, including nausea, vomiting and possible inhalation of stomach contents, pneumonia, fever, brain damage and death. Infection Hematoma — Hematoma is the col- lection of blood that may cause swelling, pain and bruising, perhaps requiring surgery to drain the blood. Hemorrhage — Hemorrhage is abnor- mal bleeding. Thrombosis — Thrombosis is abnor- mal clotting. Skin necrosis — This is skin tissue death resulting from insufficient blood flow to the skin. The chance of skin necrosis may be increased by radia- tion treatments, cortisone-like drugs, an implant too large for the avail- able space (pocket under the skin made by the surgeon for placement of the implant) or smoking.Implant Risks Capsular contracture — This is a hard- ening of the breast due to shrinkage of the scar tissue that naturally forms around the implant. Leak or rupture — Silicone gel-filled implants may leak or rupture, slowly releasing silicone gel into the sur- rounding tissue; saline-filled im- plants may rupture suddenly and deflate.10
  11. 11. Temporary or permanent change or loss of sensation in the nipple or breast tissue. Formation of calcium deposits in sur- rounding tissue, possibly causing pain and hardening. Shifting from the original placement, giving the breast an unnatural look. Interference with mammography read- ings, possibly delaying breast can- cer detection by ‘hiding’ a suspicious area. Also, it may be difficult to dis- tinguish calcium deposits formed in the scar tissue from a tumor when interpreting the mammogram. When making an appointment for a mammogram, the woman should tell the scheduler she has implants to make sure qualified personnel are onsite. At the time of the mammogram she also should remind the technician she has implants be- fore the procedure is done, so the technician can use special techniques to obtain the best mammogram and to avoid rupturing the implant.POSSIBLE RISKS OFSILICONE BREASTIMPLANTS Autoimmune-like disorders — Signs of these types of disorders include joint pain and swelling; skin tightness, redness or swelling; swelling of hands and feet; rash; swollen glands or lymph nodes; unusual fatigue; general aching. Greater chance of getting colds, viruses and flu; unusual hair loss; memory problems; headaches; muscle weak- 11
  12. 12. ness or burning; nausea or vomit- ing; and irritable bowel syndrome. Fibrositis/fibromyalgia-like disorders — These disorders result in pain, ten- derness and stiffness of muscles, ten- dons and ligaments. Cancer — There is no scientific evi- dence that silicone breast implants can increase the risk of cancer, but scientists cannot completely rule out the possibility. Average follow-up time of completed studies in women has been too short to fully evaluate this risk. Breast Feeding — It is not known if the small amounts of silicon that "bleed" from gel-filled and saline- filled implants can get into breast milk, and, if so, whether it could af- fect the nursing infant. More study is needed. Pregnancy — It is not known if a mothers breast implants can have an effect on the fetus.OTHER SILICONEIMPLANT RISKS Many of the known risks describedabove for silicone breast implants applyto any procedure that places a siliconeimplant in the human body The surgical risks noted above canresult from any implant surgery and willvary depending on the general health ofthe patient, skill of the surgeon, size andscope of the implant and numerous otherfactors.12
  13. 13. The implant risks described for sili-cone breast implants apply to silicone im-plants generally. Implants in areas otherthan the breast would not, of course, in-terfere with mammography, but could in-terfere with other diagnostic x-rays or im-aging. Two risk categories mentioned aspossible risks of silicone breast implants(autoimmune-like disorders and fibrositis/fibromyalgia-like disorders) are rare in thegeneral population as well as in siliconebreast implant recipients. While it is logi-cal to ask if these possible risks might ap-ply to other silicone implants, more in-formation is needed before this can be an-swered.Risks described bymanufacturers in the labelingfor silicone implants otherthan breast implants include: Displacement or shifting of the implant. This can occur if the surgical pocket is too large for the implant. Inadequate tissue covering. A surgical pocket that is too small, or an im- plant that is too large can result in skin thinning or loss and result in the implant protruding from the implant site. This may require sur- gical removal of the implant. Visibility of silicone implant. This is most frequently reported with nasal implants and happens when the per- son stands next to a strong light or in direct sunlight and the implant be- comes clearly outlined. 13
  14. 14. Risks of Silicone PenileImplants Failure of the implant to function as intended Sizing errors Infection, and loss of penile tissue. Loss of any natural ability to make the penis erect Loss of penile sensation or sensitivity Movement or wear of the penile im- plant Urinary obstruction or other compli- cations related to implant movement.14
  15. 15. WHERE CAN I GET MOREINFORMATION? The best source of informationabout your implant surgery is your doc-tor. He or she knows your health status,and can best inform you of those risksyou need to consider. Call the FDA consumer informationline at 1-888-INFOFDA OR 1-888-463-6332. Consumers can call this numberfor information about any product thatthe FDA regulates, including silicone im-plants. For the latest information aboutsilicone breast implants, ask for a copy ofthe FDA breast implant information pack-age. This information package also isavailable from the FDA Internet site atwww.fda.gov (from the FDA main pageclick on the "Index" icon, then choose thebreast implant link). Some silicone implant manufactur-ers provide patient information bro-chures that answer commonly askedquestions about their implants. Ask yourdoctor if one is available for the im-plant you are considering and, if so, geta copy and read it. If not, ask yourdoctor for a copy of the package insertfor the silicone implant you are consid-ering. Package inserts provide doctors im-portant information about possible risks.The package insert is written in technicallanguage and your doctor may have tohelp you understand it. 15
  16. 16. State of CaliforniaDepartment of Health Services714/744 P StreetP.O.Box 942732Sacramento, CA 94234-7320
  17. 17. Things ToConsider Before YourSiliconeImplantSurgery State of CaliforniaDepartment ofHealth Services April 1999
  18. 18. The information in this booklet iscurrent as of the date of printing.It was developed by the State ofCalifornia, Department of HealthServices, and was designed andprinted by the Medical Board ofCalifornia.To order additional copies,please write to:Silicone Implant BrochureMedical Board of California2005 Evergreen StreetSuite 1200Sacramento, CA 95815or FAX to 916 • 263 • 2479There is no charge for a singlecopy. For a bundle of 25 book-lets, enclose a check for $6.00payable to Medical Board of Cali-fornia.Questions or comments may beaddressed to:Medical Device Safety SectionFood and Drug BranchDivision of Food, Drug and Radiation SafetyCalifornia Department of Health Services601 North 7th Street, MS 357P.O. Box 942732Sacramento, CA 94234-7320Phone: 916 • 445 • 2263 i

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