Implant Statement

Breast implants are not lifetime devices and, in some cases, have been associated with complications. For more information, please click these links to details provided by three breast implant manufacturers.

Allergan

(https://www.allerganaesthetics.com/natrelle) retrieved 7.21.22

Breast implants are not considered lifetime devices. The longer people have them, the greater the chances are that they will develop complications, some of which will require more surgery. Breast implants have been associated with the development of a cancer of the immune system called breast implant–associated anaplastic large cell lymphoma (BIA-ALCL). This cancer occurs more commonly in patients with textured breast implants than smooth implants, although rates are not well defined. Some patients have died from BIA-ALCL.

Patients receiving breast implants have reported a variety of systemic symptoms, such as joint pain, muscle aches, confusion, chronic fatigue, autoimmune diseases, and others. Individual patient risk for developing these symptoms has not been well established. Some patients report complete resolution of symptoms when the implants are removed without replacement.

J&J Mentor

(https://www.breastimplantsbymentor.com/home) retrieved 7.21.22

Breast implants are not considered lifetime devices. The longer people have them, the greater the chances are that they will develop complications, some of which will require more surgery.

Breast implants have been associated with the development of a cancer of the immune system called breast implant-associated anaplastic large cell lymphoma (BIA-ALCL). This cancer occurs more commonly in patients with textured breast implants than smooth Implants, although rates are not well defined. Some patients have died from BIA-ALCL.

Patients receiving breast implants have reported a variety of systematic symptoms such as joint pain, muscle aches, confusion chronic fatigue, autoimmune diseases and others. Individual patient risk for developing these symptoms has not been well established. Some patients report complete resolution of symptoms when the implants are removed without replacement.

Sientra

(https://sientra.com/commitment-to-safety/) retrieved 7.21.22

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 board eligible 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.

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;141(4S):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.