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FDA Takes Aim at Medical Devices Review Process as Lawsuits Mount

FDA Takes Aim at Medical Devices Review Process as Lawsuits Mount

On February 12, 2019 the United States Food and Drug Administration (FDA) convened for its Obstetrics and Gynecology Devices Panel to discuss the current regulatory practices regarding implanted medical devices.

These types of devices have had a history of being involved in numerous legal battles over the years. Products such as vaginal mesh and metal hip replacements have been at the center of litigation, recalls, and a growing conversation about FDA regulatory practices.

These devices have been linked to a plethora of health complications, including pelvic pain, erosion or exposure of the mesh, infection, incontinence, and neurological deficits or dysfunctions. Legal verdicts for cases related to these medical devices have reached hundreds of millions of dollars, with class actions having arisen throughout the nation, including over 100,000 women suing manufacturers.

In reviewing this medical issue, the FDA has focused their review on their own medical device approval process. This pathway to have a device approved for the market, known as the 510(k)-clearance pathway, has received critique from many who claim this process is inadequate and effectively contributing toward the epidemic of faulty medical devices.

Those in favor of tougher regulation are arguing the 510(k) process be more rigorous to reflect the current FDA process regarding drugs entering the market. While manufacturers are claiming they are concerned about the issues caused by their devices, some of stated that the regulations used for drugs are not suitable for evaluating medical devices.

Medical Device Injury Compensation

With the FDA recently stating that complications related to these medical devices are relatively frequent, the national spotlight has shifted to the Courts to find justice for the growing number of injured patients.

Experienced mass tort lawyers have begun fighting for the rights of their client’s after they have suffered medical complications following the use of these devices. In fact, over a thousand settlements have already been reached.

With this widespread issue of flawed medical devices at the center of a nationwide debate regarding patient safety, the Whitley Law Firm believes every patient should be able to receive medical care without the fear of injury.

Whitley defective medical device attorneys are dedicated to fighting for those who have suffered at the hands of negligent medical device practices and their manufacturers. If you were injured after using one of these devices, contact us today to discuss your legal options.