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 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.
The FDA’s 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. 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 FDA requested a response from Allergan within 15 working days of issuance of the warning letter and asked Allergan to provide details about how the company will correct the violations. Failure to promptly comply with post-approval requirements may result in additional action.
The warning letter issued to Ideal Implant Inc. revealed the Ideal saline-filled breast implants were adulterated due to a 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 FDA’s warning letter requests that, in a response to the agency, Ideal Implant Inc. more adequately describe and clarify details about device complaints, including what happens when a customer cancels a complaint. The FDA also requests that the firm clarify how it tests a finished product to ensure it meets specifications.
The FDA’s inspection also revealed the 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.
The FDA requested a response from Ideal Implant Inc. within 15 working days of issuance of the warning letter with details about how the company will correct the violations. Failure to address the violations identified within the Warning Letter could result in enforcement action, such as seizure, injunction and civil money penalties.