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New Bill May Allow Regulators to Block Products With Past Safety Issues

Current law allows the Food and Drug Administration (FDA) to approve medical implants or devices even when a similar product was previously removed from the market due to safety concerns. A new bill was proposed to address this practice. The bill was catalyzed by injuries caused from faulty transvaginal mesh devices, and would close the approval loophole by allowing regulators to block the release of some medical devices based on the safety of similar products, reports Businessweek.

Vaginal Implants Act as Catalyst

This bill was pushed after the FDA was put on alert last year when patients complained of pain and internal injuries connected to use of vaginal implants made by Johnson & Johnson and C.R. Bard Inc. The medical devices were sold without going through typical human testing protocol because the FDA ruled they were similar to existing products.

Details of Bill

The bill, known as H.R. 3847, aims to remove the ability to market a product based on a determination that it is "substantially equivalent" to a preexisting device, the process used to put transvaginal mesh on the market. If the preexisting product was "recalled, corrected, or removed from the market" based on a flaw adversely affecting consumer safety, the Secretary of Health and Human Services can deny approval.

The bill amends the Federal Food, Drug and Cosmetic Act and requires the Secretary to use and update a database outlining which medical devices were removed from the market. Ultimately, the Secretary will be able to deny release of the product until additional testing is completed to ensure safety.

The bill still requires passing the Senate and approval from President Barack Obama before it will become law.

Change Aimed to Increase Consumer Safety

This amendment is intended to increase public safety by adding an extra layer of protection. Allowing regulators to require additional testing prior to market release is intended to reduce the rate of injuries suffered through using faulty medical devices.

Although these safeguards will reduce injuries if the bill is passed, products like transvaginal mesh continue to cause injuries to consumers. As a result, if you or a loved one were injured by a medical device, it is important to contact an experienced medical implant side effect lawyer to ensure all legal rights and remedies are protected.

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