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.
Ideal Implant Inc. Warning Letter
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...
Full text at GMPnews.Net