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FDA Requires Johnson & Johnson to Conduct Studies On Organ Damage

The Food and Drug Administration (FDA) is calling Johnson & Johnson and 32 fellow manufacturers to study organ damage and complications resulting from the use of vaginal mesh implants. Transvaginal mesh devices were designed to treat incontinence and pelvic organ prolapse.

Complaints Lead FDA to Demand Further Study

Businessweek reported a fivefold increase in deaths, injuries or malfunctions tied to use of the product. Studies find edges of fibers on the mesh implant "can constrict or cut internal organs after" the device is implanted, according to Bloomberg News.

Particulars of Future Studies

The FDA is requesting manufacturers, like Johnson & Johnson, collect data on results and complications of the procedure. The FDA is also continuing to monitor reports of adverse effects associated with the products. Although earlier studies were conducted, they do not clearly state whether the procedures provide benefits not present in older methods.

The FDA faces increased scrutiny from various lawsuits due to a lack of human testing prior to sale. The device manufacturers were able to bypass this requirement due to a loophole in FDA procedure. The loophole allows release without testing if the product is similar to an earlier, already fully approved device. The FDA is attempting to resolve the problem by ensuring the products now receive full testing.

Congressional Hearings

In addition, in response to the injuries caused by medical devices like transvaginal mesh, House Democrats' are pushing for Congressional Subcommittee Hearings to review the safety of these products and to assess the effectiveness of FDA device rules and regulations, as reported by Bloomberg.

U.S. Representative Henry Waxman (CA-DEM) led the charge to push for hearings by the House Energy and Commerce Committee, which is carefully investigating medical device rules. Democrats are urging the Republication lead committee to take a hard look at whether the devices in question are hazardous to the public and if FDA regulations are adequate to safeguard consumers from these potentially dangerous products.

Remedies Available

Remedies are available for victims of injuries resulting from medical devices. This includes compensation for medical and rehabilitative expenses, as well as pain and suffering. It is important to discuss your case with an experienced attorney to ensure all legal rights and remedies are protected.

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