Commitment to Safety

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.

%

Felt More Feminine

%

Felt Their Breasts Look Natural and Soft

%

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.

woman standing in doorway

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.

ForPhysicians

Letter to Plastic Surgeons – FDA Breast Panel Statement

Letter to Plastic Surgeons – Breast Implant Safety Update, February 2019

Sientra Breast Implant Warranty Information

Directions for Use – Sientra Silicone Gel Breast Implants

2019 BIA-ALCL Frequently Asked Questions from Sientra Medical Affairs

Surgical Best Practices: 14-Point Plan

ASPS – Important Notes About Breast Implant Safety

ASPS – FDA Announcement and Registry Information

ASAPS – Breast Implant-Associated Illness References

FDA – Summary of Breast Implant Risks

FDA – Statement on new efforts to protect women’s health and ensure safety of breast implants

ForPatients

Safety of Silicone

Sientra Breast Implant Safety Data

Sientra Breast Implant Warranty Information

Sientra Silicone Gel Breast Implants: Quick Facts About Breast Augmentation & Reconstruction

Sientra Breast Augmentation Patient Educational Brochure

Sientra Breast Reconstruction Patient Educational Brochure

Patient Decision Check-list

ASPS – Important Notes About Breast Implant Safety

ASAPS – Breast Implant-Associated Illness References

FDA – Summary of Breast Implant Risks

Patient Device ID Card

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