FDA Issues Stronger Safety Requirements for Breast Implants

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The US Food and Drug Administration (FDA) on Wednesday announced stronger safety requirements for breast implants, restricting sales of implants only to providers and health facilities that review potential risks of the devices with patients before surgery, via a “Patient Decision Checklist.” The agency also placed a boxed warning — the strongest warning that the FDA requires — on all legally marketed breast implants.

“Protecting patients’ health when they are treated with a medical device is our most important priority,” Binita Ashar, MD, director of the Office of Surgical and Infection Control Devices in the FDA’s Center for Devices and Radiological Health, said in a press release. “In recent years, the FDA has sought more ways to increase patients’ access to clear and understandable information about the benefits and risks of breast implants. By strengthening the safety requirements for manufacturers, the FDA is working to close information gaps for anyone who may be considering breast implant surgery.”

This announcement comes 10 years after the FDA issued a comprehensive safety update on silicone gel-filled implants, which reported a possible association between these devices and anaplastic large cell lymphoma (ALCL). The studies reviewed in the 2011 document also noted that a “significant percentage of women who receive silicone gel-filled breast implants experience complications and adverse outcomes,” the most common being repeat operation, implant removal, rupture, or capsular contracture (scar tissue tightening around the implant).

Breast augmentation has been one of the top five cosmetic procedures in the United States since 2006, according to the American Society for Plastic Surgery (ASPS), with more than 400,000 people getting breast implants in 2019. Nearly 300,000 were for cosmetic reasons, and more than 100,000 were for breast reconstruction after mastectomies.

In 2019, the FDA proposed adding a boxed warning for breast implants, stating that the devices do not last an entire lifetime; that over time the risk for complications increases; and that breast implants have been associated with ALCL, and also may be associated with systemic symptoms such as fatigue, joint pain, and brain fog. This week’s FDA action now requires that manufacturers update breast implant packaging to include that information in a boxed warning, as well as the following:

  • A patient-decision checklist

  • Updated silicone gel-filled breast implant rupture screening recommendations

  • A device description including materials used in the device

  • Patient device ID cards

The updated label changes must be present on manufacturers’ websites in 30 days, the FDA said.

The new requirements have received largely positive reactions from both physicians and patient organizations. In an emailed statement to Medscape Medical News, Lynn Jeffers, MD, MBA, the immediate past president of the American Society of Plastic Surgeons, said, “ASPS has always supported patients being fully informed about their choices and the risks, benefits, and alternatives of the options available. “We look forward to our continued collaboration with the FDA on the safety of implants and other devices.”

Maria Gmitro, president and co-founder of the Breast Implant Safety Alliance, an all-volunteer nonprofit based in Charleston, South Carolina, said that some of the language in the patient checklist could be stronger, especially when referring to breast implant associated ALCL.

To inform patients of risks more clearly, “It’s the words like ‘associated with’ that we feel need to be stronger” she said in an interview with Medscape. She also noted that women who already have breast implants may not be aware of these potential complications, which these new FDA requirements do not address.

But overall, the nonprofit was “thrilled” with the announcement, Gmitro said. “Placing restrictions on breast implants is a really big step, and we applaud the FDA’s efforts,” she added. “This is information that every patient considering breast implants should know, and we’ve been advocating for better informed consent.”

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