Allergan Hit with FDA Warning Letter Over Recalled Breast Implants

Published on May 15, 2020 by Laurie Villanueva

The U.S. Food & Drug Administration (FDA) has issued a Warning Letter to Allergan, Inc., asserting the company failed agency-mandated safety studies of now-recalled Natrelle gel-filled implants and Natrelle 410 anatomically shaped breast implants.

Allergan Breast Implant Warning Letter

According to the FDA, the 10-year post-market studies were to include nearly 60,000 participants with gel- and saline-filled implants. But nine years after issuing the mandate, the agency approved a redesigned trial protocol that lowered enrollment to 2,775 people. Nevertheless, Allergan continued to show poor recruitment and follow-up rates and did not collect adequate safety data at the four-year mark, including rates of local implant complications.

Last August, Allergan agreed to recall the Natrelle devices, as well as its Biocell textured breast implants, after an FDA investigation linked the products to a rare form of cancer called breast implant associated-anaplastic large cell lymphoma, or BIA-ALCL. But according to the FDA, the recent Natrelle breast implant recall does not exempt Allergan from the obligation to conduct the required studies.

“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,” said Binita Ashar, M.D., director of the FDA’s Office of Surgical and Infection Control Devices in the Center for Devices and Radiological Health. “The manufacturer’s low recruitment and low follow-up rates for these devices is unacceptable.”

Ideal Implants Warning Letter

The FDA also issued a Warning Letter to Dallas, Texas-based Ideal Implants for failing to adequately correct deficiencies uncovered during an agency inspection earlier this year. Among other things, the company had failed to provide timely reports of device malfunctions that could result in death or serious injury.

Ideal also neglected to maintain the proper files for processing and responding to customer complaints related to its saline-filled breast implants and did not adequately ensure that its finished products met specifications.

The FDA has given Allergan and Ideal Implants 15 days to respond to the Warning Letters, including details on how they intend to correct the violations cited by the agency. Failure to comply could result in additional action, including seizure, injunction and civil money penalties.

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