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A Lawsuit Alleges Boston Scientific Should’ve Known About Transvaginal Mesh Problems

According to a plaintiff’s attorney in a new vaginal mesh lawsuit, manufacturer Boston Scientific Corporation should have known about the transvaginal mesh problems associated with their product. For instance, on October 20, 2008, the FDA issued a public health notification entitled “Serious Complications Associated with Transvaginal Placement of Surgical Mesh in Repair of Pelvin Organ Prolapse and Stress Urinary Incontinence.”

The agency noted they had received over 1,000 reports from nine surgical mesh manufacturers of complications associated with surgical mesh devices used to repair pelvic organ prolapse and stress urinary incontinence. The complications included vaginal mesh erosion, infection, pain, and urinary problems.

The plaintiff notes that though neither Boston Scientific nor its products were mentioned specifically in the FDA’s announcement, a “review of the relevant FDA database reveals that the FDA received multiple ‘adverse event reports’ relating to this product.”

Three years later, on July 13, 2011, the FDA issued an update to its 2008 announcement, stating that serious vaginal mesh problems associated with surgical mesh, including vaginal mesh erosion, were “not rare.” From January 1, 2008 through December 31, 2010, the FDA received over 2,800 additional reports of transvaginal mesh problems.

The plaintiff brings counts of breach of warranties, negligence, and failure to warn. The plaintiff’s husband also claims loss of consortium.

A lawsuit is filed in Tennessee

The plaintiff, from Tennessee, and her husband filed their lawsuit on July 11, 2012 in the U.S. District Court for the Western District of Tennessee. According to the complaint, the plaintiff was implanted with the Boston Scientific product, and afterwards experienced debilitating personal injuries.

The couple seeks to hold Boston Scientific liable for these injuries, and for failing to warn of the risks associated with the product.

The transvaginal mesh lawsuit notes in the complaint that in 2009, the plaintiff was diagnosed as suffering from pelvic pain and stress urinary incontinence.

To treat her conditions, on November 2, 2009, surgeons implanted the Obtryx Tansobturator Mid-Urethral Sling System. According to Boston Scientific’s website, the product offers a “distinct and versatile” approach for treating stress urinary incontinence.

The purpose of transvaginal mesh

Sometimes as women age, due to multiple childbirths, surgery, or menopausal changes, the pelvic muscles can become stretched and weakened. These muscles may then no longer be strong enough to fully support pelvic organs like the uterus, bowel, and bladder. Symptoms may include pressure and incontinence, particularly when coughing, sneezing, or laughing.

The Boston Scientific device was designed to help correct the plaintiff’s pelvic organ prolapse and stress urinary incontinence. The system includes the “Advantage Mesh,” which was marketed as reducing irritation to the wall of the urethra.

According to the plaintiff, however, after she was discharged from the hospital, she experienced numerous complications. These included pain, vaginal bleeding, and dyspareunia (painful sexual intercourse).

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