Transvaginal Mesh Lawsuit Attorneys Urge Congress to Take Action
“Johnson & Johnson’s withdrawal of their defective TVM transvaginal mesh products is a good first step towards patient safety,”-- Attorney Ryan L Thompson of Watts Guerra Craft LLP
Houston, TX (Law Firm Newswire) June 19, 2012 – Transvaginal mesh lawyers Ryan L. Thompson and Mikal C. Watts, of Watts Guerra Craft LLP (WGC), were disappointed by the federal government’s recent failure to close a legal loophole that would have required FDA testing of medical devices, such as transvaginal mesh implants, prior to using such devices in patients. Johnson and Johnson recently announced the withdrawal of four types of transvaginal mesh implants that have been the subject of intense scrutiny and litigation. While this a step toward saving lives, WGC attorneys do not believe it is enough.
Thousands of women have filed transvaginal mesh lawsuits alleging serious harm from four Johnson and Johnson products: Gynecare products TVT Secur system, Prosima Pelvic Floor Repair System, Prolift Pelvic Floor Repair System and Proflit + M Pelvic Floor Repair System. On June 4, 2012, Johnson and Johnson attorneys notified the judge overseeing multiple transvaginal mesh lawsuits that their client planned to “stop commercializing” these transvaginal mesh implants in the United States within 120 days.
“While we appreciate Johnson and Johnson’s belated market withdrawal of these dangerous and defective products, other devices, with similar safety issues, remain on the market and are still being implanted into unsuspecting patients across the United States”, says attorney Ryan L. Thompson, one of WGC’s leading surgical mesh lawyers. “We need Congress to give the FDA the power it needs to protect the public.”
A loophole in current federal law allows the marketing of new medical devices without advanced FDA testing if a device is “substantially equivalent” to one already on the market. This loophole applies even if the equivalent product was recalled. Thompson says Congress had the opportunity to close the loophole last month when passing an FDA funding bill but declined to do so, despite pleas by Consumers Union and other groups as well as some legislators.
“Even the director of the FDA’s Center for Devices and Radiological Health confirmed they don’t have the power to prevent marketing of new mesh implants similar to ones recalled,” says Thompson. “That loophole puts patients at serious risk of suffering devastating injuries.”
The FDA issued concerns about surgical mesh implants in 2008 and 2011. Still, each year physicians implant surgical mesh in thousands of women suffering with pelvic organ prolapse or stress urinary incontinence and the manufacturers of these dangerous products continue to market them across the United States.
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