WASHINGTON — The FDA issued warning letters to a pair of breast implant manufacturers that failed to comply with federal regulations — including Allergan, which failed to follow-up on safety assessments for some of its implants that were recalled in 2019.
“The agency issued a warning letter to breast implant manufacturer Allergan of Irvine, California, 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 agency explained in a release. “The FDA also issued a warning letter to Ideal Implant Incorporated of Dallas, Texas, for failure to comply with current good manufacturing practice requirements and adverse event reporting requirements following an inspection conducted earlier this year.”
Following a request from the FDA, Allergan pulled all of its BIOCELL textured breast implants from markets across the globe last year due to reports of an increased risk of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) — the agency later called for the addition of boxed warnings to safety information for breast implants to properly warn patients of the associated risks. However, while Allergan’s implants were voluntarily recalled, the manufacturer was not exempt from conducting post-approval studies for their devices. And, according to the FDA, Allergan’s recruitment has been slipping in its post-approval study of the NATRELLE Silicone Gel-Filled Breast Implants (“Round Responsive implants”) and its NATRELLE 410 Highly Cohesive Anatomically Shaped Silicone-Filled Breast Implants (“Style 410 implants”). In addition, the manufacturer has failed to provide sufficient follow-up data regarding long-term complications, cancer rates, and other important safety data.
“The manufacturer’s low recruitment and low follow-up rates for these devices is unacceptable,” said Binita Ashar, MD, director of the Office of Surgical and Infection Control Devices in the Center for Devices and Radiological Health, in a statement. “The FDA will continue to hold manufacturers accountable if they fail to fulfill their obligations.”
Meanwhile, following inspections of the manufacturer’s facility in January and February, the FDA accused Ideal Implant Inc. of “failure to maintain proper files for device complaints the manufacturer received from customers, failure to establish and maintain appropriate procedures for implementing corrective and preventive actions and failure to establish and maintain adequate criteria for testing finished devices.” The agency also found that the manufacturer’s products were misbranded “because the firm failed to provide timely reports of device malfunctions to the FDA that could result in death or serious injury.”
Allergan and Ideal Implant Inc. have each been given 15 working days from the issuance of the warning letters to respond to the FDA with details of how they intend to correct these violations — and, should they fail to comply, further enforcement actions may be forthcoming, the agency warned.
The FDA added that health care providers and consumers should report any adverse events related to breast implants to the agency’s MedWatch reporting program.
John McKenna, Production Editor, BreakingMED™
Cat ID: 151
Topic ID: 88,151,730,191,192,151,725