FDA announces stronger warnings on breast implant labels

Regulatory NewsRegulatory News | 28 October 2021 |  By 

The US Food and Drug Administration on 27 October announced new labeling, including boxed warnings, to facilitate informed consumer decision-making regarding the risks of breast implants.
FDA is also restricting the sale and distribution of breast implants to providers who agree to provide patients with adequate information on their risks by reviewing a decision checklist with patients. The physician performing the breast implant must sign the checklist, and patients must be given the opportunity to initial and sign it as well.
“The FDA is requiring these restrictions based on its finding that the available information indicates such restrictions are necessary to provide a reasonable assurance of the device’s safety and effectiveness,” said the agency.
The new labeling requirements follow the recommendations set in FDA’s September 2020 guidance. (RELATED: Breast implant label guidance finalized by FDA, Regulatory Focus 28 September 2020).
FDA specifies that manufacturers of these products should include a boxed warning communicating the risk of implants to patients. The labeling should also include updated screening recommendations to prevent silicone gel-filled breast implant ruptures; a decision checklist to help patients make decisions on whether to get implants; and a description of the materials used in implants. Patients should also be issued cards with the device’s serial number, lot number, device style and device size.
The following breast implants are affected by the update:  
  • Ideal Implant’s Structured Saline Breast Implants
  • Mentor’s Saline-Filled and Spectrum Breast Implants
  • Allergan’s Natrelle Saline Filled Breast Implants
  • Allergan’s Natrelle Silicone Filled Breast Implants
  • Mentor’s MemoryShape Silicone Gel-Filled Breast Implants
  • Mentor’s MemoryGel Silicone Gel-Filled Breast Implants
  • Sientra’s OPUS Silicone Gel Breast Implants.
Manufacturers of these implants should post the updated device labeling on their websites within 30 days of this announcement.
“Protecting patients’ health when they are treated with a medical device is our most important priority,” said Binita Ashar, director of the Office of Surgical Control Devices in the Center for Devices and Radiological Health. “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.”
Breast implants are considered Class III medical devices, which require premarket approval (PMA) before they can be legally marketed.
The labeling is also aligned with earlier recommendations from FDA’s General and Plastic Surgery Devices Advisory Panel. In a 2019 meeting, the panel said FDA should consider additional postmarket data reporting requirements on breast implant manufacturers. The 2019 panel reviewed data about the thousands of breast implant-related adverse events that had been reported through FDA’s Medical Device Reporting (MDR) pathway, focusing on characterization of breast implant associated anaplastic large cell lymphoma (BIA-ALCL).
FDA announcement on breast implant labeling


© 2023 Regulatory Affairs Professionals Society.

Discover more of what matters to you