A 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.

First Company to Provide 20-Year Warranty

Because Sientra trusts in the safety and performance of our breast implants, Sientra offers the Platinum20™ Warranty, the most complete warranty program, and is the first company to provide 20-year coverage.

Platinum20™ Warranty

Deciding to have breast surgery is a very personal choice. And women should feel confident in their breast implants and their decision to have breast augmentation or reconstructive surgery.

Our intent is to strengthen the entire industry and to help drive continuous improvement in options for patients. We will continue to assure the highest patient safety by ongoing clinical studies, implant innovations and transparency with publications of our long-term safety data. If you should have any questions, please feel free to reach out to info@sientra.com or 888.708.0808.

The Safety of Silicone Breast Implants

Science-Based Facts of Silicone Gel Breast Implants

How common are breast implants?
Did you know?

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 OPUS® 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.3

A Legacy of Safety

Overall Sientra OPUS® 10-Year Clinical Study Results3

Rupture Free

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%.3 This means 14 out of 100 patients may experience capsular contracture within 10 years after receiving implants.*

*Average rate of specific complication reported across all study cohorts. Individual rates may be higher or lower depending upon multiple factors for each patient.

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.4.5

Current data suggests that BIA-ALCL occurs more frequently in women with textured implants than smooth implants.6 BIA-ALCL has been diagnosed in women with silicone and saline implants.7 Worldwide, the reported incidence rates of BIA-ALCL vary widely and within different implant surfaces.8. When caught early, BIA-ALCL is usually curable.9

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%.10

It is important for women to be advocates for their breast health and be aware of any changes in size or shape their breasts or breast implants. For any woman who is concerned about their breast health, they should see their board-certified or board-eligible plastic surgeon for evaluation.9

Learn more about potential breast implant risk in augmentation and reconstruction

Things to Remember:

Long-term clinical and real-world data supports the safety of breast implants.11 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.6

Sientra OPUS® 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.

Primary Augmentation Patient Satisfaction Rates

Important Safety Information

Important Safety Information: Sientra’s OPUS® 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 OPUS® breast implants, please visit sientra.com/resources or call Sientra at 888.708.0808. Sientra OPUS® breast implants with High-Strength Cohesive silicone gel are only available through board-certified or board-eligible plastic surgeons.

References

1. Sieber DA, et al. What’s your micromort? A patient-oriented analysis of breast-implant associated anaplastic large cell lymphoma (BIA-ALCL). Aesth Surg J. 2017;37:1-5.

2. American Society of Plastic Surgeons. 2017 Plastic Surgery Statistics Report.

3. 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.

4. 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

5. 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.

6. "Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL)". 2019. FDA. US Food and Drug Administration. Web. 06 Feb 2019

7. "Medical Device Reports of Breast Implant-Associated Anaplastic Large Cell Lymphoma". 2019. FDA. US Food and Drug Administration. Web. 06 Feb 2019

8. 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

9. "Breast Implant Associated Anaplastic Large Cell Lymphoma (BIA-ALCL)". 2019. ASPS. American Society of Plastic Surgeons. Web. 14 Mar 2019

10. 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

11. Calobrace, M.B., et al. Long-Term Safety of Textured and Smooth Breast Implants. Plast Reconstr Surg. 2018; 38-48.