FDA Issues Warning to Allergan Over Failure to Perform Adequate Safety Studies on Breast Implants
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WASHINGTON, DC — The U.S. Food and Drug Administration, or FDA, announced that the agency issued a warning letter to Allergan for improperly handling post-market studies on the safety of breast implants. Allergan, according to icij.org, is one of the world’s leading manufacturers of breast implants. The FDA admonished Allergan for not satisfying FDA standards for the following study participants who have different styles of breast implants for cancer risks. The studies should have included implant models that were taken off of the worldwide market because of the link to cancer. The FDA also admonished, in a warning letter, breast implant manufacturer Ideal Implant Incorporated for refusing to monitor complaints or appropriately correct problems inspectors identified during a routine inspection.
The FDA wants medical device manufacturers to understand the agency will pursue all companies who do not honor its regulations. Breast implant safety has garnered a substantial amount of attention in the last two years. In November of 2018, according to icij.org, thousands of women were diagnosed with illnesses they developed after having breast implantation surgery performed.
The FDA and health regulatory agencies in Canada and France banned Allergan’s Biocell breast implants. Scientific studies connected Biocell implants to a particularly rare cancer. Soon after that, Allergan announced a recall of its Biocell line of products worldwide. Through intensive investigations, the FDA learned that Allergan did not study the breast implants that were under recall around the world.
The FDA relies heavily on studies performed by medical device makers to ensure the safety of medical devices. Aftermarket studies allow regulators to assess the potential long-term effects that surface. Accordingly, the FDA came down hard on Allergan and Ideal Implant Incorporated for failing to conduct proper studies. Some commentators say that the FDA must be ready to take even more aggressive action against companies that shirk its responsibilities so that patients receive the best healthcare possible and a protected from defective medical devices.
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