Boston Scientific is facing a new transvaginal mesh lawsuit, alleging their Upsylon Y mesh caused a woman permanent complications. This transvaginal mesh lawsuit was filed by a couple from Tennessee, alleging their lives and marriage have been drastically impacted by the Upsylon Y mesh product.

Plaintiffs Sophia L. and James L. allege Boston Scientific failed to warn them against the potentially defective nature of the Upsylon Y mesh, including complications it could present.

The Upsylon Y mesh is a transvaginal mesh product that is primarily used to treat pelvic organ prolapse (POP) and stress urinary incontinence (SUI), which are conditions typically caused by weakened pelvic muscle.

POP and SUI often develop soon after intense physical trauma like childbirth, which affects the woman’s ability to control urination or keep pelvic organs from prolapsing outside their body.

The Upsylon Y mesh and other transvaginal mesh products provide additional support, and gives women discrete treatment options for these personal health conditions.

With these benefits in mind, Sophia agreed to have the Upsylon Y mesh implanted to treat her vaginal wall prolapse and had no reason to believe she was at risk for serious side effects. According to the transvaginal mesh lawsuit, the Upsylon Y mesh was implanted in Sophia on Dec. 10, 2014 and reportedly experienced painful side effects soon after.

Upsylon Y mesh is made of a monofilament polypropylene material that is supposed to be biologically safe for patients, but, according to the couple’s lawsuit, can cause potentially devastating side effects in patients.

According to the transvaginal mesh lawsuit, Sophia had experienced significant mental and physical pain and has had to undergo multiple procedures to fix internal damage allegedly caused by the Upsylon Y mesh product.

Sophia further alleges that she had to have the Upsylon Y mesh removed, with surgeons having to repair damage to her pelvic organs, tissue, and damaged nerves. In addition, Sophia says she has had to undergo numerous injuries of the pelvis, spine, and vagina and had to have portions of her female genitalia removed.

Sophia says she will most likely require additional medical procedures, and has been forced to contend with the permanent effects of the transvaginal mesh complications.

Along with her husband, Sophia opted to file legal action against Boston Scientific after discovering other women had also experienced serious transvaginal mesh complications.

Overview of Transvaginal Mesh Complications

The FDA recently reclassified transvaginal mesh as high risk devices in January 2016, after tens of thousands of women had reportedly experienced mesh erosion and infection. The FDA had first approved surgical mesh for POP treatment in 2002, and had been used for off label POP treatment since the 1990s.

In 2011, the FDA stated it had received almost 4,000 transvaginal mesh injury reports between 2005 and 2010. At this time, the FDA had concluded that transvaginal mesh complications were “not rare” and that transvaginal mesh procedures were no more effective than traditional surgery.

Over 100,000 women have reported experiencing serious transvaginal mesh complications, spurring litigation action against Boston Scientific and other manufacturers. Sophia states she would not have agreed to have the Upsylon Y mesh implanted, if she had been aware of the potential transvaginal mesh complications.

This Transvaginal Mesh Lawsuit is Case No. 3:18-cv-00888, in the U.S. District Court of the Middle District of Tennessee, Nashville Division.