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PTOSIS
RECURRENTRECURRENT
and the TISSUE ISSUE
PTOSIS
Indications for Use
SERI
®
Surgical Scaffold is indicated for use as a transitory scaffold for soft tissue support
and repair to reinforce deficiencies where weakness or voids exist that require
the addition of material to obtain the desired surgical outcome.
This includes reinforcement of soft tissue in plastic and
reconstructive surgery, and general soft tissue reconstruction.
Please see Important Safety Information inside.
A look at the role of
SERI
®
Surgical Scaffold
for soft tissue support and repair1
DEFINING THE
TISSUE ISSUE
tis•sue is•sue
noun
A condition that arises when the patient’s soft tissue, on its own,
is too weak or thin to support the desired surgical results.
It may impact the patient’s outcome immediately, or it may
cause undesirable changes in the affected area over time.1
5TABLE of CONTENTS
THE SITUATION
The absence of a consistent approach to address recurrent ptosis	 6
Traditional approaches may need extra support	 7
THE CONSIDERATIONS
Important considerations in repairing mammary soft tissue	 8
THE CRITICAL FACTOR: Address the TISSUE ISSUE
Strategies to rethink the surgical approach	 10
Key questions to consider	 12
KNOW the value of added soft tissue support
Useful approaches to soft tissue support in mastopexy surgeries	 13
WHY SERI®
Surgical Scaffold?	 14
CASES IN BRIEF
Revision mastopexy with augmentation using
SERI®
Surgical Scaffold for soft tissue support and repair	15
Mastopexy-augmentation using SERI®
Surgical Scaffold
for soft tissue support and repair	 16
Important Safety Information
Contraindications
• Patients with a known allergy to silk
• Contraindicated for direct contact with bowel or viscera where formation
of adhesions may occur
Please see additional Important Safety Information throughout this booklet.
76
The history of surgical advancements within mastopexy spans nearly
175 years, yet no consistent approach exists to help maintain the
desired surgical outcome over time.2,3
OVER A CENTURY OF PROGRESS.
STILL NO CONSISTENT APPROACH.
1840s First mastopexy/reduction procedures described4
1927 Joseph describes moving NAC4
1930 Schwarzmann describes deepithelization5
1950s Wise pattern introduced5
1960 Gonzalez-Ulloa introduces one-stage mastopexy procedure6
1973 Periareolar approach introduced7
1976 Regnault introduces grades of ptosis8
1981 Mesh used as an adjunctive soft tissue support
and repair device9
1994 ADM launched as an adjunctive soft tissue
		 support and repair device10
Traditional approaches often rely on the use of local, atrophied tissue
for reinforcement—the same weakened tissue that previously sagged.2
This may sometimes yield a short-term result and recurrent ptosis may
persist after the procedure.2
Due to the poor quality of the soft tissue, mastopexies may
warrant the need for additional tissue support.2,3
According to a survey of 150 plastic surgeons, use of additional soft tissue
support is low in mastopexy procedures (n = 147).2,
* Where appropriate,
surgeons have the opportunity to12
:
• Advise patients about the likelihood of long-term revision
• Offer additional soft tissue support to help maintain the desired results
*Methodology: Results from 150 online interviews with plastic surgeons administered from April
16 to May 2, 2013. Participating plastic surgeons were categorized as having a medium
surgery volume (defined as 6-12 augmentation procedures/month; n = 76) or a high surgery
volume (defined as ≥ 13 augmentation procedures/month; n = 68) in primary and revision
breast augmentation.2
MAY NEED EXTRA SUPPORT
TRADITIONAL APPROACHES
Up to 24% of mastopexy procedures may
require reoperation on average within1 year.11
The SITUATION
TISSUE
ISSUE
Important Safety Information (continued)
Warnings
• SERI®
Surgical Scaffold must be placed in maximum possible contact with
healthy well-vascularized tissue to encourage ingrowth and tissue remodeling
• Caution should be used when implanting SERI®
Surgical Scaffold in pregnant
women.The use of a device that can impede tissue expansion may be
hazardous during pregnancy
Please see additional Important Safety Information throughout this booklet.
The CONSIDERATIONS8
Surgeons who perform mastopexies, with or without augmentation,
face the challenge of providing their patients with lasting outcomes—
without recurrence of ptosis.2,3
To help achieve this, surgical techniques
must consider these factors:
• Loss of tissue volume secondary to13
:	
		 – Pregnancy
		 – Weight loss/gain
		 – Menopause8
• Reliance on atrophied breast tissue to provide long-term support2
• Maintaining the vasculature of the NAC2,14
• Placement of the NAC, especially during one-stage mastopexy-augmentation15
CONSIDERATIONS IN ADDRESSING
RECURRENT PTOSIS
CONSIDER THIS
LIES WITH YOU.
TISSUE
ISSUE
THE DECISION TO HELPADDRESS THE
The long-term success of a mastopexy procedure relies, in part,
on the quality of the overlying soft tissue.2
AGING WEIGHT FLUCTUATIONS
PREGNANCY CONGENITAL SOFT
TISSUE LAXITY MASSIVE WEIGHT
LOSS AFTER BARIATRIC PROCEDURES
PREGNANCY CONGENITAL SOFT
TISSUE LAXITY MASSIVE WEIGHT
LOSS AFTER BARIATRIC PROCEDURES
Important Safety Information (continued)
Adverse Reactions
Adverse reactions are those typically associated with surgically implantable
materials, including infection, inflammation, adhesion formation, fistula
formation, and extrusion.
Please see additional Important Safety Information throughout this booklet.
11The CRITICAL FACTOR10
Allergan offers preoperative surgical planning tools to help identify
the TISSUE ISSUE and support your patient’s procedure.
Ask your Allergan representative for details.
Recognize potential causes of poor mammary soft tissue
within the patient’s preoperative history.
Natural, surgeon-independent factors:
Aging2,16
	 – This may also lead to thinning skin and loss
of skin elasticity
Weight fluctuations16
	 – A potential cause of the loss of shape, projection,
and elasticity in the patient’s breasts
Pregnancy2,16
Congenital soft tissue laxity2
Massive weight loss after bariatric procedures17
Strategies to rethink the surgical approach
Identifying patients at risk and evaluating the soft tissue quality
are key to proper management of long-term surgical outcomes.2
ADDRESS THE TISSUE ISSUE
IDENTIFY. EVALUATE.
Assess the soft tissue quality as part of your routine preoperative surgical
plan. Consider these criteria when evaluating your patients’ soft tissue:
• Degree of ptosis18
• Breast position on the chest wall18
• Nipple position relative to the breast and fold19
• Skin stretch and overall skin quality18
• Tissue envelope and volume18
• Previous breast revision procedures18
• The patient’s operative goals18
MANAGE.
At this point, assess whether to add soft tissue support to help maintain
the desired surgical outcome.1
Refer to the patient’s relevant history and
soft tissue quality to determine the need to manage the TISSUE ISSUE
with a soft tissue support device.
Important Safety Information (continued)
Important: Before using SERI®
Surgical Scaffold, read the Instructions for Use
which accompany the product for full safety information. This can be found at
www.allergan.com or call Allergan Product Support at 1-800-433-8871.
Caution: Rx only.
12 13
KNOW
eep soft tissue assessment as a component of preoperative planning.
ffer added soft tissue support as a part of the patient’s mastopexy
surgery when a TISSUE ISSUE exists.
ote the potential benefits of different surgical repair techniques.
eigh the potential impact of not adding a soft tissue support device
to the patient’s mastopexy procedure.
KNOWthe value of added soft tissue support
Consider implementing these useful approaches
to soft tissue support in mastopexy surgeries:
O
N
W
K
Supporting and strengthening the patient’s soft tissue may positively
affect surgical outcomes.2
That is why there is a growing need to
provide lasting support and strength to help achieve and maintain
the desired surgical result.
CONSIDER ADDING SOFT TISSUE SUPPORT
PUTTING STRATEGIES into PRACTICE KNOW
WEIGHT LOSS AFTER BARIATRIC PROCEDURES
AGING WEIGHT FLUCTUATIONS
PREGNANCY CONGENITAL SOFT
TISSUE LAXITY MASSIVE WEIGHT
LOSS AFTER BARIATRIC PROCEDURES
?
Has the patient had massive weight loss?
Is there a significant degree of ptosis?
Is soft tissue integrity contributing to the problem?
After identifying a TISSUE ISSUE and evaluating the patient’s soft tissue quality,
surgeons should use their clinical judgment to manage the situation. Here are some
questions to ask to help determine the potential benefits of added soft tissue support:
KEY QUESTIONS TO CONSIDER
FOR PROPER MANAGEMENT
PUTTING STRATEGIES INTO PRACTICE—
Managing the TISSUE ISSUE could save your work
Has the patient had a previous mastopexy?
CASES in BRIEF 15
WHY
WHY14
Why SERI®
Surgical Scaffold?
Learn more and register for an upcoming
training opportunity at SERI.com
*Methodology: In an ovine subcutaneous thoracic wall implant study designed to
measure the strength and thickness of SERI®
Surgical Scaffold and newly generated
native tissue at up to 24 months after implantation of SERI®
.2
Note: Similar results in humans have not been confirmed.
In a survey of 92 surgeons attending the RESTORE Program BioSkills
Training Labs, 91% of responding surgeons (n = 67) would consider
using SERI®
Surgical Scaffold for soft tissue support in mastopexy.2
Important Safety Information
Contraindications
• Patients with a known allergy to silk
• Contraindicated for direct contact with bowel or viscera where formation
of adhesions may occur
Please see additional Important Safety Information throughout this booklet.
Patient assessment
• A 29-year-old woman presented with
wrinkling, rippling, stretch deformity, loss
of superior-pole fullness, severely thin and
compromised soft tissues, and pseudoptosis
• Recently experienced massive weight loss
• History of subglandular breast mastopexy-
augmentation with 350-cc implants; she
had undergone 2 revisions due to recurrent
rippling and stretching
Case conclusions
• No palpability of SERI®
Surgical Scaffold
at the first postoperative visit on day 5
or at the 4-week follow-up visit
• No complications from surgery
• The patient was pleased with the result
BEFORE use of SERI®
Surgical Scaffold
AFTER use of SERI®
Surgical Scaffold
Postoperative results: 2 years
Courtesy of Max R. Lehfeldt, MD
Pasadena, California
Revision mastopexy with augmentation using
SERI®
Surgical Scaffold for soft tissue support and repair
Here are 2 examples of how SERI®
Surgical Scaffold may help maintain
the desired result by adding soft tissue support.
CASES IN BRIEF
Results shown with Vectra®
XT imaging.
Individual results may vary.
SERI®
Surgical Scaffold is the only Silk-derived Biological Scaffold
that facilitates the generation of strong, native tissue.1,2,
* Over
time, SERI®
Surgical Scaffold is naturally replaced by new tissue
that was shown to be nearly 2x stronger than ovine fascia.2,
*
This newly generated, well-vascularized tissue provides lasting
support and strength through 24 months.2,
*
CASES in BRIEF16
Important Safety Information (continued)
Warnings
• SERI®
Surgical Scaffold must be placed in maximum possible contact with
healthy well-vascularized tissue to encourage ingrowth and tissue remodeling
Please see additional Important Safety Information throughout this booklet.
Patient assessment
• A 55-year-old woman presented
with Grade III ptosis and loose
skin stretch
• She had had 3 pregnancies and
had given birth to 3 children
Case conclusions
• No palpability of SERI®
Surgical
Scaffold at 4 months, with
minimal palpability at the
initial postoperative visit
• No postoperative complications
• Achieved soft tissue support for
the breast shape and lower
pole of the breast along with
the N:IMF distance	
Postoperative results: 18 months
Courtesy of Bradley Bengtson, MD
Grand Rapids, Michigan
Mastopexy-augmentation using SERI®
Surgical
Scaffold for soft tissue support and repair
BEFORE use of SERI®
Surgical Scaffold
AFTER use of SERI®
Surgical Scaffold
Actual patient photos. Individual results may vary.
Pre-op compared
to 4 months post-op
4 months post-op compared
to 18 months post-op
Results shown with Vectra®
XT imaging. Individual results may vary.
Results at 4 months compared
with results at 18 months
CASES IN BRIEF
Important Safety Information (continued)
Warnings (continued)
• Caution should be used when implanting SERI®
Surgical Scaffold in
pregnant women. The use of a device that can impede tissue expansion
may be hazardous during pregnancy
Adverse Reactions
Adverse reactions are those typically associated with surgically implantable
materials, including infection, inflammation, adhesion formation, fistula formation,
and extrusion.
Important: Before using SERI®
Surgical Scaffold, read the Instructions for Use
which accompany the product for full safety information. This can be found at
www.allergan.com or call Allergan Product Support at 1-800-433-8871.
Caution: Rx only.
1. SERI®
Surgical Scaffold. Instructions for Use, 2014. 2. Data on file, Allergan, Inc. 3. Dixon JM, Arnott I,
Schaverien M. Chronic abscess formation following mesh mastopexy: case report. J Plast Reconstr Aesthet
Surg. 2010;63(7):1220-1222. 4. Eisenmann-Klein M. Breast reduction and mastopexy. In: Siemionow MZ,
Eisenmann-Klein M, eds. Plastic and Reconstructive Surgery. London, UK: Springer; 2010:421-434. 5. O’Toole
JP, Song A, Rubin JP. The history of body contouring surgery. Semin Plast Surg. 2006;20(1):5-8. 6. Gonzalez-
Ulloa M. Correction of hypotrophy of the breast by means of exogenous material. Plast Reconstr Surg
Transplant Bull. 1960;25:15-26. 7. Jones FR, Tauras AP. A periareolar incision for augmentation mammoplasty.
Plast Reconstr Surg. 1973;51(6):641-644. 8. Regnault P. Breast ptosis. Definition and treatment. Clin Plast Surg.
1976;3(2):193-203. 9. de Bruijn HP, ten Thije RH, Johannes S. Mastopexy with mesh reinforcement: the
mechanical characteristics of polyester mesh in the female breast. Plast Reconstr Surg. 2009;124(2):364-371.
10. LifeCell products. LifeCell website. http://www.lifecell.com/health-care-professionals/lifecell-products/.
Accessed October 10, 2014. 11. Swanson E. Prospective comparative clinical evaluation of 784 consecutive
cases of breast augmentation and vertical mammaplasty, performed individually and in combination.
Plast Reconstr Surg. 2013;132(1):30e-45e. 12. Spear SL, Low M, Ducic I. Revision augmentation mastopexy:
indications, operations, and outcomes. Ann Plast Surg. 2003;51(6):540-546. 13. Beale EW, Ramanadham S,
Harrison B, Rasko Y, Armijo B, Rohrich RJ. Achieving predictability in augmentation mastopexy. Plast Reconstr
Surg. 2014;133(3):284e-292e. 14. Tessone A, Millet E, Weissman O, et al. Evading a surgical pitfall:
mastopexy-augmentation made simple. Aesthetic Plast Surg. 2011;35(6):1073-1078. 15. Spear SL, Dayan JH,
Clemens MW. Augmentation mastopexy. Clin Plast Surg. 2009;36(1):105-115. 16. Grewal NS, Fisher J. Why
do patients seek revisionary breast surgery? Aesthetic Surg J. 2013;33(2):237-244. 17. Hurwitz DJ. Strategies
in breast reduction and mastopexy after massive weight loss. In: Spear SL, Willey SC, Robb GL, Hammond
DC, Nahabedian MY, eds. Surgery of the Breast: Principles and Art. 3rd ed. Philadelphia, PA: Lippincott
Williams  Wilkins; 2011:1185-1204. 18. Hidalgo DA, Spector JA. Mastopexy. Plast Reconstr Surg.
2013;132(4):642e-656e. 19. Calobrace MB, Herdt DR, Cothron KJ. Simultaneous augmentation/mastopexy:
a retrospective 5-year review of 332 consecutive cases. Plast Reconstr Surg. 2013;131(1):145-156.
©2015 Allergan, Inc., Irvine, CA 92612  ®
marks owned by Allergan, Inc.
Vectra is a registered trademark owned by Canfield Scientific, Inc.
www.SERI.com  APC46HS14 143488

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143488 Mastopexy Leave Behind_ST

  • 1. PTOSIS RECURRENTRECURRENT and the TISSUE ISSUE PTOSIS Indications for Use SERI ® Surgical Scaffold is indicated for use as a transitory scaffold for soft tissue support and repair to reinforce deficiencies where weakness or voids exist that require the addition of material to obtain the desired surgical outcome. This includes reinforcement of soft tissue in plastic and reconstructive surgery, and general soft tissue reconstruction. Please see Important Safety Information inside. A look at the role of SERI ® Surgical Scaffold for soft tissue support and repair1
  • 2. DEFINING THE TISSUE ISSUE tis•sue is•sue noun A condition that arises when the patient’s soft tissue, on its own, is too weak or thin to support the desired surgical results. It may impact the patient’s outcome immediately, or it may cause undesirable changes in the affected area over time.1
  • 3. 5TABLE of CONTENTS THE SITUATION The absence of a consistent approach to address recurrent ptosis 6 Traditional approaches may need extra support 7 THE CONSIDERATIONS Important considerations in repairing mammary soft tissue 8 THE CRITICAL FACTOR: Address the TISSUE ISSUE Strategies to rethink the surgical approach 10 Key questions to consider 12 KNOW the value of added soft tissue support Useful approaches to soft tissue support in mastopexy surgeries 13 WHY SERI® Surgical Scaffold? 14 CASES IN BRIEF Revision mastopexy with augmentation using SERI® Surgical Scaffold for soft tissue support and repair 15 Mastopexy-augmentation using SERI® Surgical Scaffold for soft tissue support and repair 16
  • 4. Important Safety Information Contraindications • Patients with a known allergy to silk • Contraindicated for direct contact with bowel or viscera where formation of adhesions may occur Please see additional Important Safety Information throughout this booklet. 76 The history of surgical advancements within mastopexy spans nearly 175 years, yet no consistent approach exists to help maintain the desired surgical outcome over time.2,3 OVER A CENTURY OF PROGRESS. STILL NO CONSISTENT APPROACH. 1840s First mastopexy/reduction procedures described4 1927 Joseph describes moving NAC4 1930 Schwarzmann describes deepithelization5 1950s Wise pattern introduced5 1960 Gonzalez-Ulloa introduces one-stage mastopexy procedure6 1973 Periareolar approach introduced7 1976 Regnault introduces grades of ptosis8 1981 Mesh used as an adjunctive soft tissue support and repair device9 1994 ADM launched as an adjunctive soft tissue support and repair device10 Traditional approaches often rely on the use of local, atrophied tissue for reinforcement—the same weakened tissue that previously sagged.2 This may sometimes yield a short-term result and recurrent ptosis may persist after the procedure.2 Due to the poor quality of the soft tissue, mastopexies may warrant the need for additional tissue support.2,3 According to a survey of 150 plastic surgeons, use of additional soft tissue support is low in mastopexy procedures (n = 147).2, * Where appropriate, surgeons have the opportunity to12 : • Advise patients about the likelihood of long-term revision • Offer additional soft tissue support to help maintain the desired results *Methodology: Results from 150 online interviews with plastic surgeons administered from April 16 to May 2, 2013. Participating plastic surgeons were categorized as having a medium surgery volume (defined as 6-12 augmentation procedures/month; n = 76) or a high surgery volume (defined as ≥ 13 augmentation procedures/month; n = 68) in primary and revision breast augmentation.2 MAY NEED EXTRA SUPPORT TRADITIONAL APPROACHES Up to 24% of mastopexy procedures may require reoperation on average within1 year.11 The SITUATION
  • 5. TISSUE ISSUE Important Safety Information (continued) Warnings • SERI® Surgical Scaffold must be placed in maximum possible contact with healthy well-vascularized tissue to encourage ingrowth and tissue remodeling • Caution should be used when implanting SERI® Surgical Scaffold in pregnant women.The use of a device that can impede tissue expansion may be hazardous during pregnancy Please see additional Important Safety Information throughout this booklet. The CONSIDERATIONS8 Surgeons who perform mastopexies, with or without augmentation, face the challenge of providing their patients with lasting outcomes— without recurrence of ptosis.2,3 To help achieve this, surgical techniques must consider these factors: • Loss of tissue volume secondary to13 : – Pregnancy – Weight loss/gain – Menopause8 • Reliance on atrophied breast tissue to provide long-term support2 • Maintaining the vasculature of the NAC2,14 • Placement of the NAC, especially during one-stage mastopexy-augmentation15 CONSIDERATIONS IN ADDRESSING RECURRENT PTOSIS CONSIDER THIS LIES WITH YOU. TISSUE ISSUE THE DECISION TO HELPADDRESS THE The long-term success of a mastopexy procedure relies, in part, on the quality of the overlying soft tissue.2
  • 6. AGING WEIGHT FLUCTUATIONS PREGNANCY CONGENITAL SOFT TISSUE LAXITY MASSIVE WEIGHT LOSS AFTER BARIATRIC PROCEDURES PREGNANCY CONGENITAL SOFT TISSUE LAXITY MASSIVE WEIGHT LOSS AFTER BARIATRIC PROCEDURES Important Safety Information (continued) Adverse Reactions Adverse reactions are those typically associated with surgically implantable materials, including infection, inflammation, adhesion formation, fistula formation, and extrusion. Please see additional Important Safety Information throughout this booklet. 11The CRITICAL FACTOR10 Allergan offers preoperative surgical planning tools to help identify the TISSUE ISSUE and support your patient’s procedure. Ask your Allergan representative for details. Recognize potential causes of poor mammary soft tissue within the patient’s preoperative history. Natural, surgeon-independent factors: Aging2,16 – This may also lead to thinning skin and loss of skin elasticity Weight fluctuations16 – A potential cause of the loss of shape, projection, and elasticity in the patient’s breasts Pregnancy2,16 Congenital soft tissue laxity2 Massive weight loss after bariatric procedures17 Strategies to rethink the surgical approach Identifying patients at risk and evaluating the soft tissue quality are key to proper management of long-term surgical outcomes.2 ADDRESS THE TISSUE ISSUE IDENTIFY. EVALUATE. Assess the soft tissue quality as part of your routine preoperative surgical plan. Consider these criteria when evaluating your patients’ soft tissue: • Degree of ptosis18 • Breast position on the chest wall18 • Nipple position relative to the breast and fold19 • Skin stretch and overall skin quality18 • Tissue envelope and volume18 • Previous breast revision procedures18 • The patient’s operative goals18 MANAGE. At this point, assess whether to add soft tissue support to help maintain the desired surgical outcome.1 Refer to the patient’s relevant history and soft tissue quality to determine the need to manage the TISSUE ISSUE with a soft tissue support device.
  • 7. Important Safety Information (continued) Important: Before using SERI® Surgical Scaffold, read the Instructions for Use which accompany the product for full safety information. This can be found at www.allergan.com or call Allergan Product Support at 1-800-433-8871. Caution: Rx only. 12 13 KNOW eep soft tissue assessment as a component of preoperative planning. ffer added soft tissue support as a part of the patient’s mastopexy surgery when a TISSUE ISSUE exists. ote the potential benefits of different surgical repair techniques. eigh the potential impact of not adding a soft tissue support device to the patient’s mastopexy procedure. KNOWthe value of added soft tissue support Consider implementing these useful approaches to soft tissue support in mastopexy surgeries: O N W K Supporting and strengthening the patient’s soft tissue may positively affect surgical outcomes.2 That is why there is a growing need to provide lasting support and strength to help achieve and maintain the desired surgical result. CONSIDER ADDING SOFT TISSUE SUPPORT PUTTING STRATEGIES into PRACTICE KNOW WEIGHT LOSS AFTER BARIATRIC PROCEDURES AGING WEIGHT FLUCTUATIONS PREGNANCY CONGENITAL SOFT TISSUE LAXITY MASSIVE WEIGHT LOSS AFTER BARIATRIC PROCEDURES ? Has the patient had massive weight loss? Is there a significant degree of ptosis? Is soft tissue integrity contributing to the problem? After identifying a TISSUE ISSUE and evaluating the patient’s soft tissue quality, surgeons should use their clinical judgment to manage the situation. Here are some questions to ask to help determine the potential benefits of added soft tissue support: KEY QUESTIONS TO CONSIDER FOR PROPER MANAGEMENT PUTTING STRATEGIES INTO PRACTICE— Managing the TISSUE ISSUE could save your work Has the patient had a previous mastopexy?
  • 8. CASES in BRIEF 15 WHY WHY14 Why SERI® Surgical Scaffold? Learn more and register for an upcoming training opportunity at SERI.com *Methodology: In an ovine subcutaneous thoracic wall implant study designed to measure the strength and thickness of SERI® Surgical Scaffold and newly generated native tissue at up to 24 months after implantation of SERI® .2 Note: Similar results in humans have not been confirmed. In a survey of 92 surgeons attending the RESTORE Program BioSkills Training Labs, 91% of responding surgeons (n = 67) would consider using SERI® Surgical Scaffold for soft tissue support in mastopexy.2 Important Safety Information Contraindications • Patients with a known allergy to silk • Contraindicated for direct contact with bowel or viscera where formation of adhesions may occur Please see additional Important Safety Information throughout this booklet. Patient assessment • A 29-year-old woman presented with wrinkling, rippling, stretch deformity, loss of superior-pole fullness, severely thin and compromised soft tissues, and pseudoptosis • Recently experienced massive weight loss • History of subglandular breast mastopexy- augmentation with 350-cc implants; she had undergone 2 revisions due to recurrent rippling and stretching Case conclusions • No palpability of SERI® Surgical Scaffold at the first postoperative visit on day 5 or at the 4-week follow-up visit • No complications from surgery • The patient was pleased with the result BEFORE use of SERI® Surgical Scaffold AFTER use of SERI® Surgical Scaffold Postoperative results: 2 years Courtesy of Max R. Lehfeldt, MD Pasadena, California Revision mastopexy with augmentation using SERI® Surgical Scaffold for soft tissue support and repair Here are 2 examples of how SERI® Surgical Scaffold may help maintain the desired result by adding soft tissue support. CASES IN BRIEF Results shown with Vectra® XT imaging. Individual results may vary. SERI® Surgical Scaffold is the only Silk-derived Biological Scaffold that facilitates the generation of strong, native tissue.1,2, * Over time, SERI® Surgical Scaffold is naturally replaced by new tissue that was shown to be nearly 2x stronger than ovine fascia.2, * This newly generated, well-vascularized tissue provides lasting support and strength through 24 months.2, *
  • 9. CASES in BRIEF16 Important Safety Information (continued) Warnings • SERI® Surgical Scaffold must be placed in maximum possible contact with healthy well-vascularized tissue to encourage ingrowth and tissue remodeling Please see additional Important Safety Information throughout this booklet. Patient assessment • A 55-year-old woman presented with Grade III ptosis and loose skin stretch • She had had 3 pregnancies and had given birth to 3 children Case conclusions • No palpability of SERI® Surgical Scaffold at 4 months, with minimal palpability at the initial postoperative visit • No postoperative complications • Achieved soft tissue support for the breast shape and lower pole of the breast along with the N:IMF distance Postoperative results: 18 months Courtesy of Bradley Bengtson, MD Grand Rapids, Michigan Mastopexy-augmentation using SERI® Surgical Scaffold for soft tissue support and repair BEFORE use of SERI® Surgical Scaffold AFTER use of SERI® Surgical Scaffold Actual patient photos. Individual results may vary. Pre-op compared to 4 months post-op 4 months post-op compared to 18 months post-op Results shown with Vectra® XT imaging. Individual results may vary. Results at 4 months compared with results at 18 months CASES IN BRIEF
  • 10. Important Safety Information (continued) Warnings (continued) • Caution should be used when implanting SERI® Surgical Scaffold in pregnant women. The use of a device that can impede tissue expansion may be hazardous during pregnancy Adverse Reactions Adverse reactions are those typically associated with surgically implantable materials, including infection, inflammation, adhesion formation, fistula formation, and extrusion. Important: Before using SERI® Surgical Scaffold, read the Instructions for Use which accompany the product for full safety information. This can be found at www.allergan.com or call Allergan Product Support at 1-800-433-8871. Caution: Rx only. 1. SERI® Surgical Scaffold. Instructions for Use, 2014. 2. Data on file, Allergan, Inc. 3. Dixon JM, Arnott I, Schaverien M. Chronic abscess formation following mesh mastopexy: case report. J Plast Reconstr Aesthet Surg. 2010;63(7):1220-1222. 4. Eisenmann-Klein M. Breast reduction and mastopexy. In: Siemionow MZ, Eisenmann-Klein M, eds. Plastic and Reconstructive Surgery. London, UK: Springer; 2010:421-434. 5. O’Toole JP, Song A, Rubin JP. The history of body contouring surgery. Semin Plast Surg. 2006;20(1):5-8. 6. Gonzalez- Ulloa M. Correction of hypotrophy of the breast by means of exogenous material. Plast Reconstr Surg Transplant Bull. 1960;25:15-26. 7. Jones FR, Tauras AP. A periareolar incision for augmentation mammoplasty. Plast Reconstr Surg. 1973;51(6):641-644. 8. Regnault P. Breast ptosis. Definition and treatment. Clin Plast Surg. 1976;3(2):193-203. 9. de Bruijn HP, ten Thije RH, Johannes S. Mastopexy with mesh reinforcement: the mechanical characteristics of polyester mesh in the female breast. Plast Reconstr Surg. 2009;124(2):364-371. 10. LifeCell products. LifeCell website. http://www.lifecell.com/health-care-professionals/lifecell-products/. Accessed October 10, 2014. 11. Swanson E. Prospective comparative clinical evaluation of 784 consecutive cases of breast augmentation and vertical mammaplasty, performed individually and in combination. Plast Reconstr Surg. 2013;132(1):30e-45e. 12. Spear SL, Low M, Ducic I. Revision augmentation mastopexy: indications, operations, and outcomes. Ann Plast Surg. 2003;51(6):540-546. 13. Beale EW, Ramanadham S, Harrison B, Rasko Y, Armijo B, Rohrich RJ. Achieving predictability in augmentation mastopexy. Plast Reconstr Surg. 2014;133(3):284e-292e. 14. Tessone A, Millet E, Weissman O, et al. Evading a surgical pitfall: mastopexy-augmentation made simple. Aesthetic Plast Surg. 2011;35(6):1073-1078. 15. Spear SL, Dayan JH, Clemens MW. Augmentation mastopexy. Clin Plast Surg. 2009;36(1):105-115. 16. Grewal NS, Fisher J. Why do patients seek revisionary breast surgery? Aesthetic Surg J. 2013;33(2):237-244. 17. Hurwitz DJ. Strategies in breast reduction and mastopexy after massive weight loss. In: Spear SL, Willey SC, Robb GL, Hammond DC, Nahabedian MY, eds. Surgery of the Breast: Principles and Art. 3rd ed. Philadelphia, PA: Lippincott Williams Wilkins; 2011:1185-1204. 18. Hidalgo DA, Spector JA. Mastopexy. Plast Reconstr Surg. 2013;132(4):642e-656e. 19. Calobrace MB, Herdt DR, Cothron KJ. Simultaneous augmentation/mastopexy: a retrospective 5-year review of 332 consecutive cases. Plast Reconstr Surg. 2013;131(1):145-156.
  • 11. ©2015 Allergan, Inc., Irvine, CA 92612  ® marks owned by Allergan, Inc. Vectra is a registered trademark owned by Canfield Scientific, Inc. www.SERI.com  APC46HS14 143488