FDA calls for boxed warning on breast implants
The FDA issued draft guidance today recommending inclusion of a boxed warning on breast implant labeling to ensure women receive and understand complete information about their benefits and potential risks.
The guidance also calls for a patient decision checklist in breast implant labeling, as well as updated recommendations related to screening patients for potential device rupture.
“There is a distinct opportunity to do more to protect women who are considering breast implants,” FDA Principal Deputy Commissioner Amy Abernethy, MD, PhD, and Jeff Shuren, MD, JD, director of FDA’s Center for Devices and Radiological Health, said in joint statement. “We believe women should have thoughtful and balanced discussions with their health care providers about both the benefits and risks of breast implants based on clear and current information. This draft guidance is an important step in making that happen.”
In July, in response to a request from FDA, Allergan recalled specific models of its textured breast implants due to a potential risk for breast implant-associated anaplastic large cell lymphoma (BIA-ALCL).
At the time of the recall, the FDA reported 573 unique cases of BIA-ALCL and 33 patient deaths worldwide. The majority (83%; n = 481) of those cases had been attributed to Allergan implants.
Earlier this year, the FDA held a public advisory panel meeting about breast implant safety. The agency also has worked with patients and other stakeholders on the issue.
“We have heard from many women that they are not fully informed of the risks when considering breast implants,” Abernethy and Shuren wrote. “They’ve stated that they need more information to facilitate meaningful conversations with their doctors and to make appropriate decisions for themselves. Many stakeholders suggested that a boxed warning and patient decision checklist could provide this information.”
The FDA recommended the boxed warning specify that breast implants have been associated with BIA-ALCL and may be associated with other systemic symptoms, such as joint pain or fatigue. The warning also should indicate that breast implants are not lifetime devices, specify that the likelihood of complications increases with time, and specify that additional surgery may be necessary to address complications.
The FDA’s draft guidance also recommends that manufacturers include a checklist at the end of brochures or informational booklets to help guide a patient’s consultation with their surgeon and give patients a chance to acknowledge the risks of breast implants.
The guidance also included new recommendations for breast implant rupture screening for patients with silicone gel-filled breast implants. The agency proposed patients without symptoms be screened with MRI or ultrasound at 5 years or 6 years after implantation, then every 2 years thereafter. Current labeling recommends MRI screenings starting at 3 years after implantation, followed by every other year thereafter.
“These new proposed screening recommendations are based on data showing rupture rates are higher 5 to 6 years after implantation, recommendations from the American College of Radiology, recommendations from the FDA panel meeting earlier this year, data suggesting that ultrasound is an effective screening method for asymptomatic patients and our awareness of poor patient compliance with the existing MRI recommendations,” Abernethy and Shuren wrote. “By proposing updates to the recommendations based on current science and other information, the FDA hopes to make it easier for patients to comply with these new recommendations.”
The FDA guidance also recommends breast implant manufacturers include easy-to-understand product ingredient information in the device’s labeling, and it also includes updates to previous recommendations regarding patient device cards.
The draft guidance is available for public comment.
“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 health care decisions that fit patients’ needs and lifestyle,” Abernethy and Shuren wrote. “After a period of public comment, once the guidance is finalized, manufacturers may choose to follow the recommendations in the final guidance or they may choose other methods of labeling their devices, so long as the labeling complies with applicable FDA laws and regulations.”