The FDA Just Strengthened Its Safety Requirements for Breast Implants
While "boob jobs" are a safe and now familiar procedure, many of us have also seen Botched. In reality, most cosmetic surgeries do come with at least a small risk of a poor outcome, but when it comes to breast implants these risks can be dangerous or even deadly. That's one of the reasons that last week, the U.S. Food and Drug Administration took several steps to help patients considering breast implants make more informed decisions before surgery. Breast augmentation, one of the most common cosmetic surgeries in the United States, is an important procedure for those seeking reconstruction after breast cancer or those who simply wish to transform their breasts' size or shape. Because of this, the FDA continuously updates their research and practices when it comes to implants, and these just-mandated restrictions focus on patient awareness.
These new efforts include new labeling for all legally-marketed implants, which will include a "patient decision checklist" meant to ensure those seeking implants fully understand the risks, benefits, and full range of information regarding the specific implants they're considering. This checklist will be discussed between the patient and provider, both of who must sign off on the checklist before the augmentation can take place. (Implant manufacturers will be required to post within 30 days of the FDA's ruling, so we'll update this story with what, exactly, these checklists include as we find out more.) The FDA has also restricted the sale and distribution of breast implants to only health care providers and facilities that provide this checklist to patients.
Pre-surgical checklists can help protect both patient and provider. "These lists make sure every single patient has understood certain key points, are easier to review than long and rambling documents, and they provide greater liability coverage for the surgeon and manufacturer on those issues," says Steven Teitelbaum, M.D., an associate clinical professor of plastic surgery at the UCLA School of Medicine. He does point out that in his experience, these comprehensive lists seldom change a patient's final decision regarding surgery.
“We are all accustomed to signing consents and releases, whether to enroll in an exercise class or to update the operating system on our phones…. [this checklist] will help patients make more informed decisions, but the reality is that no one inclined to get an implant chooses not to do so when you show them the paperwork," he says. "Most patients getting implants today have extensively researched implants online, and by the time they are ready to sign the consent, they have already made up their mind." But here's where patient and doctor relationships become more important: “What patients pay attention to is how the doctor explains each of the issues in their own words. A patient is probably inclined to trust the perspective [though which] their chosen surgeon describes the issues.”
In addition to the checklist, the new labels will include updated silicone gel-filled breast implant rupture screening recommendations, a device description with a list of specific materials in the device, and a patient device card which tells patients which specific implant they've received. These comprehensive restrictions were based on recommendations from the General and Plastic Surgery Devices Panel in 2019, where health-care professionals discussed the latest research involving benefits and risks of breast implants indicated for breast augmentation and reconstruction. Finally, the FDA released updated post-approval study data regarding the long-term effects of implants.
“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," said Binita Ashar, M.D., director of the office of surgical and infection control devices in the Center for Devices and Radiological Health, in an FDA press release. “By strengthening the safety requirements for manufacturers, the FDA is working to close information gaps for anyone who may be considering breast implant surgery.” All things considered, more information is always welcome where surgery is concerned.
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