Last week FDA issued warning letters to breast implant manufacturers Allergan and Ideal Implant, Inc. The warning letter to Allergan called out “serious deficiencies” in the company’s post-approval study involving the evaluation of its Natrelle Silicone Gel-Filled breast implants and the Natrelle 410 Highly Cohesive Anatomically Shaped Silicone-Filled Breast Implants—both implants were recalled last year. Allergan’s failure to address the agency’s concerns related to poor recruitment and follow-up rates were in violation of the premarket approval order.
FDA’s warning letter to Ideal Implant noted that the company’s 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 agency stated that the products were misbranded because Ideal Implants did not provide timely reports of implant malfunctions to the FDA.
Both companies have 15 working days to inform FDA of how they will correct the violations.
Earlier last year, Mentor Worldwide and Sientra were issued warning letters from FDA for failure to conduct post-approval studies that met agency requirements.