143488 mastopexy leave behind_st

PTOSIS

RECURRENTRECURRENT

and the TISSUE ISSUEPTOSIS

Indications for UseSERI® 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 ISSUEtis•sue is•suenounA 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 SITUATIONThe absence of a consistent approach to address recurrent ptosis 6Traditional approaches may need extra support 7

THE CONSIDERATIONSImportant considerations in repairing mammary soft tissue 8

THE CRITICAL FACTOR: Address the TISSUE ISSUEStrategies to rethink the surgical approach 10Key questions to consider 12

KNOW the value of added soft tissue supportUseful approaches to soft tissue support in mastopexy surgeries 13

WHY SERI® Surgical Scaffold? 14

CASES IN BRIEFRevision mastopexy with augmentation using SERI® Surgical Scaffold for soft tissue support and repair 15Mastopexy-augmentation using SERI® Surgical Scaffold for soft tissue support and repair 16

Important Safety InformationContraindications• 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 SUPPORTTRADITIONAL APPROACHES

Up to 24% of mastopexy procedures may require reoperation on average within 1 year.11

The S ITUATION

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


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 ADDRESSINGRECURRENTPTOSIS

CONSIDER THIS

LIES WITH YOU.

TISSUE ISSUE

THE DECISION TO HELP ADDRESS 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 ReactionsAdverse reactions are those typically associated with surgically implantable materials, including infection, inflammation, adhesion formation, fistula formation, and extrusion.


11The CRIT ICAL FACTOR 10

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 approachIdentifying 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

KNOWeep 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.

KNOW the 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 in to PRACTICE KNOW

WEIGHT LOSS AFTER BARIATRIC PROCEDURESAGING 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

WHY 14

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 InformationContraindications• Patients with a known allergy to silk• Contraindicated for direct contact with bowel or viscera where formation

of adhesions may occur


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, MDPasadena, 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 BRIEF 16

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


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, MDGrand 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 ReactionsAdverse 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.

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