Boston Scientific Mesh Implant Lawsuits Pile Up, Near 300

Boston Scientific Mesh Implant Lawsuits Pile Up, Near 300Sheila Roach is one of hundreds across the country who received surgery to treat pelvic discomfort and urinary incontinence, but ended up with a more problematic and painful health condition than before, Massachusetts Market reports.

Roach's lawsuit, filed on Tuesday, May 8, is similar to dozens more that have been filed in Boston federal court. The complaint states that a mid-urethral sling system manufactured by the company has led to debilitating pain and infections – both of which have worsened since her first attempt to correct the problem with surgery in 2010.

Boston Scientific isn't alone in the dispute. All over the country, several of its rival manufacturers are facing lawsuits over vaginal mesh implants that were inserted to treat incontinence or a condition known as pelvic organ prolapse. The surge in defective medical device lawsuits has become a multi-million dollar setback for these companies, while the federal cases against Boston Scientific are being consolidated in Charleston, West Virginia.

According to the National Library of Medicine, pelvic organ prolapse is a relatively common condition that occurs to in women as internal muscles that support pelvic organs stretch and weaken over time, allowing the organs to drop.

The condition often leads to incontinence, which can be treated in a number of ways besides vaginal mesh, including weight loss, cutting caffeine or performing special pelvic muscle exercises known as Kegel exercises.

A National Problem

One malpractice lawsuit lawsuit in Charleston says that as many as 1,300 lawsuit have been filed across the country that claim vaginal mesh inserts have caused serious problems, with as many as 170 naming Boston Scientific in their complaints. In Middlesex County, Massachusetts, more than 100 lawsuits have been filed in the court of Judge Diane Kottmyer, according to the news source.

The explosion of lawsuits may stem from a U.S. Food and Drug Administration (FDA) ruling in 2011 that found the events were not rare, which came as a reversal of its decision in 2008 that such occurrences were not widespread. The agency also ruled that the treatment offers no extra benefits compared to traditional treatments that do not involve surgical mesh.

The media outlet stated that Boston Scientific has declined to comment on the lawsuits, and holds fast to its position that the mesh inserts are an appropriate treatment for patients with pelvic organ prolapse or incontinence. The company is now working with the FDA to provide accurate information about the mesh products to both doctors and patients.

But despite the company's efforts to provide more information, more patients are coming out saying they were not fully informed of the potential risks of the surgery. Sheila Roach contents that that company is underreporting problems stemming from the mesh, and is withholding information about information on its products.

One Boston lawyer involved in Boston Scientific lawsuits says the issues described in the complaints have led to changes in the way the FDA clears medical devices for sales. The devices were originally treated as Class II devices, meaning to get clearance, all makers had to do was prove the products were similar to others already on the market.

The increase in lawsuits over surgical mesh is one of many factors that have influenced the FDA to more rigorously scrutinize medical devices, said Bruce Jackson, a Northern Securities analyst. Jackson says companies like Boston Scientific are finding it more difficult to get their products on the shelves due to the more intense FDA studies.

Similar lawsuits have been filed against C.R. Bard, Johnson and Johnson and American Medical Systems regarding mesh implants.