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The FDA Plans To Inform the Public on "Emerging Signals" For Medical Devices

While A Welcome Development, This Is Too Late For Victims of Morcellation

In a memorandum titled "Public Notification of Emerging Postmarket Medical Device Signals" the Food and Drug Administration (FDA) announced that it intends to take a more proactive approach to warning the public about potentially dangerous medical devices. Currently, the FDA relies on reports of patient deaths, complications and other adverse outcomes before deciding whether to warn the public about drugs and devices.

In 2016, the FDA intends to provide the public more guidance about "emerging signals" on medical devices. Per the FDA, emerging signals involve new information on devices that the FDA is currently reviewing. If the FDA discovers information that could conceivably change the benefit-risk profile of a device, it will make this information known, even if the information has not been fully validated, and even if the FDA does not have specific recommendations.

By taking this approach, the FDA hopes to "help health care providers, patients, and consumers make informed treatment choices based on the most current available information." By doing so, this can potentially "reduce or limit the number of patients exposed to the potential risk." While these steps will undoubtedly save lives, it is too late for many, including women who died needlessly due to medical devices that were not sufficiently tested.

How Did The FDA Fail Victims Of Morcellation?

The FDA's lax warning systems have unquestionably cost many women their lives. For women with undiagnosed uterine cancer (leiomyosarcoma) who underwent hysterectomies or fibroid removals, the morcellator spread the cancer throughout the abdominal cavity. This led to upstaged cancer and for many, death.

The FDA never tested morcellators for use on hysterectomies. In fact, device manufacturers relied on the FDA's "fast track" procedure to approve these devices for use. From the early 1990s until late 2014, the FDA stood by despite increasing evidence that morcellators upstaged uterine cancer. Currently, dozens of families who have lost loved ones due to power morcellators have brought claims against the makers of these devices.

The lawyers of Fay Law Group, P.A., work with families across the United States who have been harmed by defective or unsafe medical devices. We represent clients in the current Multidistrict Litigation (MDL) against Ethicon and other manufacturers of morcellators.

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