Democrats Seek Hearings for FDA Medical Device Approval

Last week, House Democrats asked for hearings to examine the accuracy and safety of FDA screening processes of medical devices. California Representative Henry Waxman led the Democrats of the Energy and Commerce Committee in writing a letter of request for these hearings to some chairmen of the Energy and Commerce Committee. Specifically, the hearings would look at the approval process for medical devices that get implanted into patients, such as transvaginal mesh. Transvaginal mesh has caused serious injuries to patients over the years, and Representative Waxman claims that the implants and those who approve of them are in need of reform.

The number of claims that have risen out of transvaginal mesh cases are high, and are suggestive of a flaw in the FDA's process of approval for new medical devices. Transvaginal mesh implants were approved through the FDA's 510(k) process. This particular process gives manufacturers the ability to gain approval for a product without clinical testing. The negative reports that the FDA has received from users of transvaginal mesh number in the thousands. In the year 2010 alone, an estimated 300,000 women received the implant and currently there are more than 650 transvaginal mesh lawsuits pending. Of those lawsuits are some against manufacturers such as C.R. Bard and Johnson & Johnson.

If you have used transvaginal mesh to treat bladder or pelvic prolapse problems and sustained side effects such as erosion, bleeding, or in some serious cases, organ perforation, you should contact a pharmaceutical injury attorney from Arnold & Itkin immediately. These types of injuries are very serious, and you shouldn't have to suffer without compensation. Don't hesitate to contact a transvaginal mesh attorney from our firm if you have suffered the same or similar side effects. By contacting our firm, you can be sure that you will receive the quality of legal expertise you can trust, so contact a pharmaceutical injury lawyer from Arnold & Itkin today.