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Boston Scientific Named In 300 Transvaginal Mesh Lawsuits | cialis online

Boston Scientific Named In 300 Transvaginal Mesh Lawsuits

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Device maker, Boston Scientific, has been named in 300 transvaginal mesh lawsuits. The controversial devices are typically used during surgical procedures to treat pelvic organ prolapse (POP) and/or stress urinary incontinence (SUI). Sadly, patients describe horrific pain and infections that worsen even after corrective surgery is attempted, leaving these women with limited options and debilitating health responses.

Transvaginal mesh devices were approved through the U.S. Food & Drug Administration’s (FDA) 510(k) fast-track approval process. The 501(k) enables a device access to the market with reduced pre-market safety testing if that device is similar to a previously approved device. Because of the significant outpouring of adverse reactions reports associated with these devices, as well as mounting lawsuits, the agency is considering rescinding 510(k) approvals for transvaginal mesh devices used in POP repair. As a matter-of-fact, the FDA recently asked transvaginal mesh device makers to conduct safety studies of their products.

In 1999, Boston Scientific recalled its ProteGen Sling, following many complaints of pain, infections, and injuries. Now, Johnson & Johnson is involved in a number of transvaginal mesh lawsuits involving a product approved via a 510(K) clearance because of its similarity to the defective Boston Scientific ProteGen sling, said NewsInferno.

Boston Scientific, said Massachusetts Market (Mass. Market), maintains that transvaginal placement of mesh for SUI and POP remains an important patient treatment options. But, plaintiffs suffering from inflammation and infection, pain from mesh shrinkage, extrusion of mesh through the vaginal wall, and pain during intercourse and urination—just some of the reported reactions,—now wonder if they received sufficient information on the devices’ possible risks.

In one case, the plaintiff accuses Boston Scientific of routinely minimizing problems, underreporting and withholding information, on its vaginal mesh sling products, from patients, doctors, and the FDA, said Mass. Massachusetts. Undergoing surgery in 2008 for pelvic discomfort and incontinence, Sheila Roach filed a lawsuit last week in Boston federal court, blaming the device on her incapacitating pain and infections, which continue and continue to worsen, despite 2010 corrective surgery, said Mass. Market.

Federal cases against Boston Scientific are being consolidated in Charleston, West Virginia, and similar lawsuits have been filed against C.R. Bard and American Medical Systems, in addition to Johnson & Johnson. Some 1,300 federal lawsuits, as a matter-of-fact, have been filed against the four firms; about 170 name Boston Scientific. At least 100 more have been filed against Boston Scientific in Middlesex County and are under the oversight of Judge Diane Kottmyer, bringing the total lawsuits filed against Boston Scientific to about 300, to date.

The FDA said in a July Safety Communication that it received 2,874 new reports of complications linked to transvaginal surgical mesh procedures from January 2008 through December 2010; 1,503 were associated with POP repairs and 1,371, with SUI repairs. According to agency, even when women undergo surgery, sometimes multiple times, to remove defective mesh, complications continue because it nearly impossible to completely remove the device.

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