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Insurance Carriers Push for Stronger Regulations on Medical Devices

An influential health insurer trade group has called for more stringent rules related to the approval and tracking of medical devices. The request follows revelations of gaps or loopholes in the federal regulatory procedures which allow potentially dangerous medical devices to be put on the market with minimal safety and performance testing. In particular, the group referenced a medical tool used in performing hysterectomies which, despite being widely available, has been found to contribute to the spread of cancer in patients.

This week, America's Health Insurance Plans, an organization representing nearly 1300 health insurers who provide coverage for over 200 million Americans, sent a letter to United States Senator Bob Casey, D-Pennsylvania, citing the dangers discovered regarding laparoscopic power morcellators. Since the 1990s, morcellators have been used to remove fibroids, or benign uterine growths, frequently during hysterectomies. Last year, the U.S. Food and Drug Administration (FDA) announced that women undergoing such procedures may be at higher risk for a certain type of malignant cancer, and use of the devices can potentially spread the cancerous tissue and worsen the condition.

While medical officials are reporting a significant drop in the use of power morcellators, they remain on the market. Johnson & Johnson, once the largest manufacturer of such devices, however, has withdrawn from the market.

The insurance group expressed concern over an FDA approval system commonly called 510(k), which allows a large number of medical devices to reach market without clinical studies proving effectiveness and safety. Instead, a manufacturer must show that a device is substantially equivalent to a product already on the market. Only a small number of medical devices, which are deemed higher-risk, are subject to more significant testing or trials.

In addition to tightening testing procedures and closing potentially dangerous regulatory gaps, the insurance organization also called for better tracking procedures. Currently, only hospitals and manufacturers are required to report serious issues with medical devices, but it can take time for true problems to be identified. Surgical tools, such as morcellators or the duodenoscope linked to last year's superbug outbreak, are not generally included in claims data to insurers, so carriers may not be aware of how frequently they are being used. An effort to implement use of device identifiers is under way and improving such a system can help insurance carriers join the fight against dangerous medical devices.

If you have been negatively affected by any type of defective or dangerous medical device, the manufacturer could be liable for your illness or injuries. The first step, however, is understanding your situation and our team can help you do just that. Contact an experienced Illinois defective medical device attorney today to schedule a free consultation.

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