UNITED STATES – June 1, 2020 – According to the FDA, the agency has issued warning letters to two U.S. breast implant manufacturers. The warning letters were issued due to the failure of the companies to comply with regulatory requirements. Allergan, based in Irvine, California, received a warning letter from the FDA concerning the company’s failure to administer post-approval studies that evaluate the long-term safety and dangers of two models of textured breast implants. Both models were pulled from the market in 2019.
The FDA also distributed a warning letter to Ideal Implant Incorporated, based in Dallas, Texas, for its failure to comply with current manufacturing requirements and its failure to comply with the FDA’s adverse event reporting requirements following an inspection administered earlier this year.
In the last several years, the FDA has set up systems to help monitor the safety and dangers of breast implants. The FDA also requires post-approval studies for all breast implants marketed inside the United States. In a coordinated effort with the Plastic Surgeons Foundation and the American Society of Plastic Surgeons, the FDA developed the Patient Registry and Outcomes for Breast Implants and Anaplastic Large Cell Lymphoma (ALCL) Etiology and EpidemiologyExternal Link Disclaimer(PROFILE). PROFILE collects real-world data concerning implant patients with a medical diagnosis of Breast Implant Associated ALCL (BIA-ALCL). The data amassed from PROFILE contributes to a greater comprehension of BIA-ALCL. This information helps the FDA provide communication updates to alert the public about breast implant-related diseases such as BIA-ALCL.
The FDA also developed the National Breast Implant Registry External Link Disclaimer. This platform is responsible for collecting real-world data on the safety and reliability of breast implants. The registry includes information the FDA accumulates in post-approval studies concerning the long-term breast implant safety and may help enhance the knowledge of the long-term risks connected with breast implants.
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