Home Patient Resources Commitment to Safety About Investors For U.S. Surgeons COMMITMENT to safety WE’RE GUIDED BY THE SCIENCE SUPPORTING OUR PRODUCTS WHICH CONTINUES TO CONFIRM THE LONG-TERM SAFETY AND EFFECTIVENESS OF ALL SIENTRA IMPLANTS. At Sientra, patient safety and product quality are our highest priority. That is why, from our inception, we have exclusively entrusted the safety and patient satisfaction of our breast implants to only the most qualified surgeons in our industry – board-certified and board-eligible plastic surgeons. Sientra is committed to providing transparent, evidence-based information about our implants to help physicians and patients make an informed decision. UNDERSTAND THE BENEFITS AND RISKS Undergoing any surgical procedure involves risks. We entrust patient safety and satisfaction to only the most qualified surgeons in our industry, which is why we offer breast implants exclusively to board-certified or board-eligible plastic surgeons in the United States. Women should always talk to their board-certified or board-eligible plastic surgeon about the different implant options, the known benefits and risks associated with any procedure, and their individual needs, to make an informed decision. It is important for women to know that complications may occur after surgery with breast implants. Below are a few of the key complications associated with breast implant surgery reported in Sientra’s 10-Year Clinical Study.1 IMPLANT RUPTURE Through 10 Years, in general, a patient’s risk of developing a rupture is 7.9%. This means 8 out 100 patients may experience a rupture through 10 years.* CAPSULAR CONTRACTURE During the healing process after surgery, in some women, the scar tissue (capsule) squeezes the implant. It can result in firmness or hardening of the breast. Through 10 Years, in general, a patient’s risk of capsular contracture is 13.5%.1 This means 14 out of 100 patients may experience capsular contracture within 10 years after receiving implants.* BREAST IMPLANT-ASSOCIATED ANAPLASTIC LARGE CELL LYMPHOMA (BIA-ALCL) BIA-ALCL is NOT breast cancer. BIA-ALCL is a rare and treatable type of non-Hodgkin T-cell lymphoma. Women with breast implants have a small but increased risk of developing this.2,3 Current data suggests that BIA-ALCL occurs more frequently in women with textured implants than smooth implants.4 BIA-ALCL has been diagnosed in women with silicone and saline implants.5 Worldwide, the reported incidence rates of BIA-ALCL vary widely and within different implant surfaces.6 When caught early, BIA-ALCL is usually curable.7 It is important to understand how rare the occurrence is and put the numbers into perspective. The risk of developing ALCL from a breast implant is 0.003%.8 It is important for women to be advocates for their breast health and be aware of any changes in size or shape of their breasts or breast implants. For any woman who is concerned about their breast health, they should see their board-certified or boardeligible plastic surgeon for evaluation.7 THINGS TO REMEMBER: Long-term clinical and real-world data supports the safety of breast implants.9 Because of this: The FDA and all leading medical societies currently do not recommend the removal of implants in women without symptoms. The FDA and leading medical societies currently do not recommend changing the routine medical care and follow-up for women with implants. Patients should contact their board-certified plastic surgeon with any changes to breast shape or size, including pain, lumps or swelling.4 SIENTRA BREAST IMPLANTS ARE FDA-APPROVED AND SAFE DEVICES THAT OFFER MANY QUALITY OF LIFE BENEFITS FOR WOMEN. Women choose primary breast augmentation surgery to increase the size and proportion of their breast(s). Most women who have undergone breast implant surgery have reported high levels of satisfaction with their body image and the shape, feel and size of their implants. In Sientra’s Clinical Study, most primary and revision-augmentation patients were pleased with the results of their implant surgery. Most women who underwent primary or revision-augmentation with Sientra Implants felt their breast implants made them feel more feminine and more attractive. In addition, the majority of these women indicated that their breast implants made them feel better about themselves. 0% FELT MORE FEMININE 0% FELT THEIR BREASTS LOOK NATURAL AND SOFT 0% FELT THEIR CLOTHES FIT BETTER (primary augmentation cohort) *Average rate of specific complication reported across all study cohorts. Individual rates may be higher or lower depending upon multiple factors for each patient. SEE THE INDUSTRY’S MOST comprehensive 20-year warranty Because we believe in the safety and performance of our implants, we can offer the industry’s best warranty. Our Sientra Platinum20™ Product Replacement and Limited Warranty Program provides the most comprehensive protection, longest length of coverage, most financial assistance, and least amount of warranty restrictions amongst all implant brands. For complete details about the terms and conditions of the Sientra Platinum20 program and Sientra breast implants visit resources. If you’re ready to explore your options regarding breast augmentation or reconstruction surgery, we encourage you to reach out to your board-certified plastic surgeon. FOR physicians Letter to Plastic Surgeons – FDA Breast Panel Statement VIEW Letter to Plastic Surgeons – Breast Implant Safety Update, February 2019 VIEW Sientra Breast Implant Warranty Information VIEW Directions for Use – Sientra Silicone Gel Breast Implants VIEW 2019 BIA-ALCL Frequently Asked Questions from Sientra Medical Affairs VIEW Surgical Best Practices: 14-Point Plan VIEW ASPS – Important Notes About Breast Implant Safety VIEW ASPS – FDA Announcement and Registry Information VIEW ASAPS – Breast Implant-Associated Illness References VIEW FDA – Summary of Breast Implant Risks VIEW FDA – Statement on new efforts to protect women’s health and ensure safety of breast implants VIEW FOR patients Safety of Silicone VIEW Sientra Breast Implant Safety Data VIEW Sientra Breast Implant Warranty Information VIEW Sientra Silicone Gel Breast Implants: Quick Facts About Breast Augmentation & Reconstruction VIEW Sientra Breast Augmentation Patient Educational Brochure VIEW Sientra Breast Reconstruction Patient Educational Brochure VIEW Patient Decision Check-list VIEW ASPS – Important Notes About Breast Implant Safety VIEW ASAPS – Breast Implant-Associated Illness References VIEW FDA – Summary of Breast Implant Risks VIEW Patient Device ID Card VIEW connect with us Group 3 Group 8 Group 9 SCROLL TO TOP IMPORTANT SAFETY INFORMATION: Sientra’s Silicone Gel Breast Implants are indicated for breast augmentation in women at least 22 years old and for breast reconstruction. Breast augmentation includes primary breast augmentation to increase the breast size, as well as revision surgery to correct or improve the result of primary breast augmentation surgery. Breast reconstruction includes primary reconstruction to replace breast tissue that has been removed due to cancer or trauma or that has failed to develop properly due to a severe breast abnormality. Breast reconstruction also includes revision surgery to correct or improve the results of a primary breast reconstruction surgery. Breast implant surgery is contraindicated in women with active infection anywhere in their bodies, with existing cancer or pre-cancer of their breast who have not received adequate treatment for those conditions and, who are pregnant or nursing. Key complications include capsular contracture, implant removal, rupture and reoperation. For more detailed information about the risks and benefits of Sientra breast implants, please visit sientra.com/resources or call Sientra at 888.708.0808. Sientra breast implants with high-strength cohesive silicone gel are only available through board-certified or board-eligible plastic surgeons. The sale and distribution of this device is restricted to users and/or user facilities that provide information to patients about the risks and benefits of this device in the form and manner specified in the approved labeling provided by Sientra, Inc. REFERENCES: 1. Stevens WG, et al. Ten-year core study data for sientra’s food and drug administration-approved round and shaped breast implants with cohesive silicone gel. Plast Reconstr Surg. 2018;145:7S-19S. 2. Thompson PA, et al. Breast implant-associated anaplastic large cell lymphoma: a systematic review of the literature and mini-meta analysis. Curr Hematol Malig Rep. 2013; 8(3):196-210.2 3. Benjamin K, et al. Breast implant-associated anaplastic large cell lymphoma: updated results from a structured expert consultation process. Plast Reconstr Surg Glob Open. 2015; 3(1): e296. 4. “Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL)”. 2019. FDA. US Food and Drug Administration. Web. 06 Feb 2019 5. “Medical Device Reports of Breast Implant-Associated Anaplastic Large Cell Lymphoma”. 2019. FDA. US Food and Drug Administration. Web. 06 Feb 2019 6. Hamdi M. Association Between Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL) Risk and Polyurethane Breast Implants: Clinical Evidence and European Perspective. Aesth Surg J. 2019; 39(S1):S49-S54 7. “Breast Implant Associated Anaplastic Large Cell Lymphoma (BIA-ALCL)”. 2019. ASPS. American Society of Plastic Surgeons. Web. 14 Mar 2019 8. Clemens, MW. “Breast Implant Associated Anaplastic Large Cell Lymphoma (BIA-ALCL) Resources: By the numbers, and what they mean”. ASPS. American Society of Plastic Surgeons. 2019. Web. 08 Feb 2019 9. Calobrace, M.B., et al. Long-Term Safety of Textured and Smooth Breast Implants. Plast Reconstr Surg. 2018; 38-48. PRIVACY STATEMENT TERMS OF USE SAFETY COMPLIANCE RESOURCES PATENTS CONTACT US CAREERS © 2021 Sientra, Inc. All rights reserved. This website uses cookies and other technologies to enhance site navigation, analyze site usage and assist in marketing efforts . You may find out more about our use of cookies in our Privacy Statement here. By continuing to use this site you accept our use of cookies. Learn more Got it!