Two breast implant manufacturers were issued warning letters from the U. S. Food and Drug Administration (FDA) on May 14th for failure to comply with required studies and manufacturing and reporting requirements. Allergan of Irvine, California was issued a warning letter concerning two separate premarket approval orders: failure to conduct post-approval studies to assess the long-term safety and risks of two voluntarily-recalled models of breast implants: NATRELLE Silicone Gel-Filled Breast Implants (“Round Responsive implants”) and its NATRELLE 410 Highly Cohesive Anatomically Shaped Silicone-Filled Breast Implants (“Style 410 implants”). Ideal Implant Incorporated of Dallas, Texas was also issued a warning letter by the FDA for failing to comply with good manufacturing practice requirements as well as adverse event reporting requirements.
Every manufacturer of approved silicone gel or saline-filled implants is required to conduct post-approval studies. Post-market studies are essential to monitor safety and risks particularly when an implant has been recalled. Allergan’s implants have been identified as increasing the risk of breast implant associated anaplastic large cell lymphoma. The FDA has requested a response from Allergan within 15 working days of issuance of warning letter citing deficiencies in post-approval studies including low recruitment and follow-up rates to assess long-term outcomes in patients who are already implanted with these recalled devices.
Ideal Implant Inc. was cited by the FDA for failure to adhere to quality system regulations including reporting of device-related adverse events. FDA inspectors found potential violations of the Federal Food, Drug, and Cosmetic Act during onsite visits in January and February 2020. The FDA determined that corrective actions taken by Ideal Implant Inc. after these inspections were inadequate. Among violations cited were the adulterating of Ideal saline-filled breast implants, failure to establish and maintain appropriate procedures for implementing corrective and preventative actions and failure to establish and maintain adequate criteria for testing finished devices. FDA inspectors found that some of Ideal Implant Inc.’s products were misbranded and that the firm failed to provide timely reports of device malfunctions that could result in death or serious injury.
Significantly, the FDA has asked Ideal Implant Inc. to clarify how it tests a finished product to ensure it meets specifications. If Ideal Implant Inc. does not address these violations within 15 working days of issuance, the firm will face enforcement action such as seizure, injunction and civil monetary penalties. The FDA announcement can be found here: https://www.fda.gov/news-events/press-announcements/fda-issues-warning-letters-two-breast-implant-manufacturers-part-ongoing-efforts-protect-patients
Cowper Law LLP is currently on the Plaintiff Steering Committee in the Allergan Biocell Textured Implant Litigation before Judge Martinotti (MDL 2921). If you or someone you know has been implanted with Allergan textured breast implants, please call our firm at 877.529.3707 for a free consultation with one of our attorneys.