Posted 14 May 2020 | By
"The FDA's actions today are part of the agency's ongoing commitment to its public health mission of ensuring patient access to safe and effective medical devices," FDA officials said in a statement. "The FDA remains committed to thoughtful, scientific, transparent, public dialogue concerning breast implant safety and effectiveness."
Allergan was warned for failing to conduct post-approval studies on long-term safety and risks regarding two products – Natrelle Silicone Gel-Filled Breast Implants and Natrelle 410 Highly Cohesive Anatomically Shaped Silicone-Filled Breast Implants.
Regarding the former device, the company did not adequately conduct a 10-year large post-approval study, enroll enough patients in that study or collect adequate data on safety endpoints including long-term complications, connective tissue diseases, neurological impacts, reproductive issues, psychosocial well-being of patients, breast imaging compliance and rupture results, according to the FDA. The agency also noted that the company did not collect local complication rate data from physicians at specified intervals.
For the latter, the FDA warned the company that it had not adequately evaluated the long-term performance of the device and had not enrolled enough subjects in its post-approval studies.
"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 Binita Ashar, director of the Office of Surgical and Infection Control Devices in the Center for Devices and Radiological Health. "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."
Ideal Implant received its warning letter about an FDA inspection of its Dallas facility in early February. The inspection found that the facility was not in compliance with current good manufacturing practice requirements.
Specifically, FDA deigned Ideal Implant's saline-filled breast implants were adulterated due to several factors. The agency noted that the company did not properly maintain files regarding patients’ complaints, did not establish and maintain procedures for corrective and preventive actions (CAPA), and did not keep appropriate criteria for testing manufactured devices. The agency is seeking more information on those practices and procedures.
Each company was given 15 working days to respond to its warning letter.