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Policy Archive

FORCE Weighs in on Breast Implant Safety and Informed Consent

Device Safety & Drug Development

December 23, 2019 - Today, FORCE submitted comments on U.S. Food and Drug Administration's proposed labeling and patient communication guidelines for breast implants. These updates follow a device safety hearing and recall of certain textured breast implants earlier this year. If enacted, the guidance will revise those established in 2006 by adding a boxed warning, patient decision checklist, revised rupture screening recommendations, and more.

The proposed changes follow July 2019 action to protect women from breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) by requesting that Allergan, the manufacturer of a specific type of textured implant, recall certain models of its textured breast implants from the U.S. market due to the risk of BIA-ALCL.

Per the agency's request, Allergan recalled its BIOCELL textured breast implant products, including: Natrelle Saline-Filled breast implants, Natrelle Silicone-Filled breast implants, Natrelle Inspira Silicone-Filled breast implants, and Natrelle 410 Highly Cohesive Anatomically Shaped Silicone-Filled breast implants. The recall also includes tissue expanders used by patients prior to breast augmentation or reconstruction, including Natrelle 133 Plus Tissue Expander and Natrelle 133 Tissue Expander with Suture Tabs.

Read our XRAY review for a more in-depth analysis of the recall and related issues.

See the "Related Resources" box below for more history behind this new guidance, recall, and FDA meetings that took place earlier this year.

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HISTORY

May 2, 2019 - The FDA released a statement on the agency's new efforts to protect women's health and help to ensure the safety of breast implants. The statement follows a 2-day meeting on the safety of breast implants and the surgical mesh frequently used in reconstructive surgeries. FDA staff and members of the General and Plastic Surgery Devices Advisory Committee were joined by industry representatives, professional societies, and members of the public to review the data available, and to make recommendations for future use. A FORCE representative attended the meeting and made remarks during the public comments period on March 26. 

Key topics discussed during the meeting included:

Breast Implant Illness (BII)
BII is an umbrella term used to describe a collection of symptoms and illnesses thought to be related to breast implants. Women who experience these problems may be having an autoimmune or allergic response to a foreign object (implants) being placed in the body. Currently, there is no established medical definition or diagnostic criteria for BII but many are calling for better research and informed consent. Women with a personal or family history of autoimmune disease or allergies are encouraged to discuss this with their surgeons when considering breast implants.

BIA-ALCL
Breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) is a cancer that can develop in the capsule around an implant used in breast reconstruction or augmentation. The estimated lifetime risk of BIA-ALCL is less than 1%. BIA-ALCL has been linked to textured implants, although the FDA says there are a small number of reported cases with smooth implants. The agency recently sent a letter to healthcare providers in an effort to increase awareness. Important information is posted on the FDA website and professional societies have created patient resources and safety information. Materials and continuing education for clinicians have also been developed.

Implant Rupture
The typical lifespan for a breast implant ranges from 10-20 years. If an implant tears or develops a hole, it is called a rupture. The rupture rate usually correlates with the age of the implant but earlier ruptures may occur due to a defect, surgical error, or blunt trauma from a fall or accident. If a rupture occurs, the doctor usually recommends removing and replacing the implant. There is disagreement about the best way to monitor women with breast implants. The FDA recommends an MRI three years after implantation and once every two years after that, but some healthcare professional groups disagree, suggesting that MRIs should only be used if a problem is suspected. The lack of consistent guidelines and a standard of care for screening women with implants is a significant issue. FORCE is encouraging the FDA to work with medical societies and implant manufacturers to develop uniform recommendations.

Surgical Mesh
Acellular dermal matrix (ADM), also known as surgical mesh, is used in the majority of implant-based breast reconstructions. While ADM is FDA-approved for use in other indications such as pelvic, abdominal, and burn surgeries, it is not officially approved for use in breast reconstruction. The FDA expressed concern that the use of ADMs may complicate the ability to determine the cause of implant-related illnesses, and is asking manufacturers to launch studies on its safety and efficacy in breast reconstruction. Ultimately, the agency may require approval for using ADM in breast surgeries.

Read our blog on the FDA meeting for a more comprehensive overview of the issues and proceedings, and encourage you to read our XRAY review on a study of women with implants. It's clear that independent, high-quality research is needed. Only with well-designed, long-term studies will we better understand BII, BIA-ALCL, and the overall safety of implants.

We are now participating in a Breast Device Collaborative Community to advise the FDA on important issues related to breast implants, including improved informed consent and implant monitoring. FORCE continues to follow and weigh-in on this topic and will keep the community informed.