The FDA issued warning letters today to two breast implant manufacturers for failure to comply with regulatory requirements.
One letter went to Allergan (now part of AbbVie) for failing to comply with requirements — under two separate premarket approval orders — to conduct post-approval studies to assess the long-term safety and risks of two models of breast implants, both of which were voluntarily recalled from the market last year. The FDA also issued a warning letter to Ideal Implant (Dallas, Texas) for failure to comply with current good manufacturing practice requirements and adverse event reporting requirements following an inspection conducted earlier this year.
Every manufacturer of FDA-approved silicone gel-filled breast implants must conduct post-approval studies to further evaluate the implants’ safety and effectiveness and to answer additional scientific questions about the long-term safety and potential risks of breast implants that their premarket clinical trials were not designed to answer. Generally, a manufacturer must still comply with post-approval requirements even if a breast implant has been voluntarily recalled from the market, in part, to continue assessing long-term outcomes in patients who are already implanted with these devices, according to the agency.
The warning letter to Allergan noted several serious deficiencies in the manufacturer’s post-approval study to evaluate its Natrelle silicone gel-filled breast implants (“Round Responsive implants”) and its Natrelle 410 highly cohesive anatomically shaped silicone-filled breast implants (“Style 410 implants”). The post-approval study group of subjects with Round Responsive implants has shown poor recruitment and follow-up rates, according to the letter. Allergan’s failure to address these concerns and comply with its post-approval study requirements is a violation of the firm’s premarket approval order, the agency added.
“The FDA imposes post-approval requirements because they are an important tool for ensuring the safety and effectiveness of the medical devices we regulate,” said Dr. Binita Ashar, director of the Office of Surgical and Infection Control Devices in the Center for Devices and Radiological Health, in a news release. “The agency has been diligently tracking post-approval studies as part of our ongoing efforts to evaluate, understand and provide updates to the public on breast implant safety and risks. Post-approval studies are especially important to inform our understanding of the long-term potential risks associated with Allergan’s implants, including the models that have since been recalled from the market due to increased risk of breast implant associated anaplastic large cell lymphoma. The manufacturer’s low recruitment and low follow-up rates for these devices is unacceptable. The FDA will continue to hold manufacturers accountable if they fail to fulfill their obligations.”
The FDA began reporting on cases of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL), a type of non-Hodgkin’s lymphoma and a known risk from breast implants, in 2011.
In its warning letter to Ideal Implant, the FDA said that an inspection in January and February 2020 revealed that the company failed to:
- Maintain proper files for device complaints the received from customers.
- Establish and maintain appropriate procedures for implementing corrective and preventive actions.
- Provide timely reports of device malfunctions to the FDA that could result in death or serious injury.
- Establish and maintain adequate criteria for testing finished devices.
Although Ideal Implant Inc. responded to the agency’s observations, most of the corrective actions they took were not adequate, according to Ashar.
In its warning letter, the FDA asked Ideal Implant to better describe details about device complaints, including what happens when a customer cancels a complaint. And it asked the company to clarify how it tests a finished product to ensure it meets specifications.
The agency gave each company 15 working days to explain how they will correct the violations. Failure to promptly comply with post-approval requirements may result in additional action.
Neither company immediately responded to requests for comment on the warning letters.