Key Points
- On October 27, 2021, the U.S. Food and Drug Administration (FDA) announced stronger safety requirements for breast implants, which include a boxed warning and “patient decision checklist,” in a move to enhance patient safety and increase transparency around implant risks.
- As part of informed patient consent, the FDA is requiring that “the patient must be given the opportunity to initial and sign the patient decision checklist and it must be signed by the physician implanting the device” prior to surgery.
- For more information on breast implant safety, read our breast implant safety checklist and guide.
UPDATE (10/29/2021): The U.S. Food and Drug Administration (FDA) has announced several new breast implant safety requirements to better inform and protect breast augmentation patients.
Binita Ashar, M.D., director of the Office of Surgical and Infection Control Devices in the Center for Devices and Radiological Health at the FDA, offered the following statement: “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. As the FDA continues to evaluate the overall effects of breast implants in patients, today’s actions help ensure that all patients receive the information they need to make well-informed decisions affecting their long-term, personal health.”
To that end, the agency is restricting the sale and distribution of breast implants to only healthcare providers who use the “patient decision checklist” brochure to review with prospective patients the risks, benefits, and alternatives to breast implants, as part of the informed consent process. As recently reported by The New York Times, “the checklist states explicitly that there are some medical conditions that should preclude women from getting implants.” It also notes certain conditions that may predispose women to a “higher risk of a poor outcome.”
Each implant manufacturer will modify the standard checklist to reflect the unique risks and nuances specific to their specific devices. According to the FDA, “the patient must be given the opportunity to initial and sign the patient decision checklist and it must be signed by the physician implanting the device.”
In addition to the checklist (which highlights potential problems like capsular contracture and rupture), the FDA is requiring that all breast implant labeling feature a boxed warning alerting patients to significant risks, such as BIA-ALCL—a rare lymphoma that can be triggered by certain textured implants—along with a host of systemic symptoms (commonly referred to as breast implant illness or BII) that some doctors and patients believe may be linked to breast implants.
The new labeling must also include revamped rupture screening recommendations for patients with silicone gel breast implants and identify all the materials used to make the devices, as well as any chemicals that can be released from the implants over time.
The FDA is giving breast implant manufacturers 30 days to post the updated device labeling to their websites.
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After years of controversy surrounding breast implants, the U.S. Food and Drug Administration (FDA) is proposing new guidance for implant manufacturers and providers in order to ensure women are sufficiently warned about the risks associated with breast implants. Most notably, the agency is pushing for a boxed warning—the strongest form of caution required by the FDA—on the packaging of implants to inform consumers about potential complications, such as cancer.
“Breast implants are not considered lifetime devices” and “the chance of developing complications increases over time” are examples of the boxed warning the FDA is urging implant manufacturers to add to the packaging of their devices. The agency is also asking that a checklist, spelling out the possible risks associated with breast implants, is provided to prospective patients to review before officially scheduling their surgery. Doctors would then be responsible for reviewing this checklist with their patients. More than 70,000 people have signed a petition advocating for this checklist to become mandatory, and support for this plea appears to grow each day.
“Taken as a whole, we believe this draft guidance, when final, will result in better labeling for breast implants that will ultimately help patients better understand breast implant benefits and risks, which is a critical piece in making healthcare decisions that fit patients’ needs and lifestyle,” said FDA Principal Deputy Commissioner Dr. Amy Abernethy and Dr. Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health in a recent statement.
This new direction comes after several breast implant controversies arose over the past year. In July, Allergan recalled its textured breast implants due to the risk of a rare cancer called breast implant–associated anaplastic large-cell lymphoma (BIA-ALCL). Other breast implant complications, including ruptures, rippling and loss of nipple sensation, are also possible after the surgery. Thousands of women have also reported a post-implant onset of symptoms, ranging from cognitive issues to chronic fatigue to joint pain— a condition broadly referred to as “breast implant illness.” Numerous breast implant patients testified before the FDA at an advisory panel meeting in March regarding the breast implant–related illnesses they’d experienced, bringing the agency under fire for not having more stringent rules to ensure that patients are educated properly before undergoing surgery. The FDA says studies show no evidence of breast implants causing breast implant illness.
Existing studies, however, have their limitations. Many breast implant studies are funded by implant manufacturers or plastic surgery associations, and they often focus only on well-known diseases rather than symptoms (like those described in breast implant illness). The New York Times reports that the studies also don’t examine long term effects of implants—information that women should know before undergoing breast implant surgery.
In addition to the aforementioned proposals, the FDA is also imploring that manufacturers include an exact ingredients list on packaging so consumers know which chemicals are included in the device before it’s inserted into their bodies. The agency is also suggesting new screening guidelines for women who already have silicone implants, recommending that patients undergo imaging scans to search for ruptures five to six years after implant surgery and every two years after that.
For more information on breast implant safety, read our breast implant safety guide.
