Massachusetts court sides with Boston Scientific in second vaginal-mesh lawsuit: report

Jurors in Massachusetts state court ruled that Boston Scientific's Obtryx transobturator mid-urethral sling was not defectively designed and that the company had provided sufficient warning about the product's potential risks, Bloomberg reported Friday. In the case, the plaintiff alleged that the device, which she had implanted for incontinence problems, caused her pain and necessitated surgical removal.

"We are pleased that after considering the evidence, the jury found no design or warning defect with our pelvic-repair product," remarked Boston Scientific spokeswoman Kelly Leadem. The verdict marks the second victory for the company in as many trials alleging that the vaginal mesh erodes, causing organ damage and pain, according to court filings. The device maker currently faces more than 12 000 lawsuits over the inserts.

Most of the cases against Boston Scientific and other manufacturers of similar devices have been consolidated in a US district court in West Virginia, with other cases ongoing in California, Delaware, Massachusetts, Missouri and New Jersey.

In February 2013, a jury in New Jersey ordered Johnson & Johnson to pay $7.76 million in punitive damages, as well as $3.35 million in compensation to a woman who claimed injuries from the company's Gynecare Prolift vaginal mesh implant. California jurors in 2012 said C.R. Bard must pay damages of $5.5 million over claims that its Avaulta Plus vaginal implant caused incontinence and chronic pain, while Endo Health Solutions recently agreed to pay $830 million to settle more than 20 000 lawsuits alleging that the company's vaginal mesh inserts, which include the Perigee, Apogee and Elevate implants, eroded in some women, leaving them incontinent and in pain.

Meanwhile, the FDA in 2012 ordered more than 30 vaginal implant makers, including Boston Scientific and Johnson & Johnson, to assess the rates of organ damage and complications associated with their products. In April, the agency also issued two proposed orders that if finalised would reclassify surgical mesh for transvaginal pelvic organ prolapse from a moderate-risk to a high-risk device and require companies to submit a premarket approval application.

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