A woman who lost her case in the Boston Scientific transvaginal mesh litigation more than two years ago is getting another opportunity in court. Previously, she filed a lawsuit alleging that she suffered injuries caused by the Pinnacle Pelvic Floor Repair Kit, which was implanted in 2010 to treat an anterior pelvic organ prolapse, or cystocele. She alleged that the device was to blame for severe pain and other complications. The lawsuit filed on her behalf alleged that Boston Scientific failed to warn her or her physician about the risks.
The plaintiff’s case went to trial, and the jury issued a verdict in favor of Boston Scientific. They found that the transvaginal mesh implant was not defectively designed. However, an appeals court has ruled that the plaintiff is entitled to another trial due to the improper omission of information.
Transvaginal mesh implants were approved to treat pelvic organ prolapse and stress urinary incontinence. The devices came under increased scrutiny due to a mounting number of complaints and personal injury lawsuits. One point of contention was the fact that transvaginal mesh implants were approved through 510(k), a process that essentially allows medical devices onto the market without a substantial amount of clinical testing if the manufacturer can show that it is “substantially equivalent” to a previously approved device. Plaintiffs and transvaginal mesh patient advocates argued that manufacturers used 510(k) as a loophole to get pelvic mesh onto the market.
In light of these complaints, the U.S. Food and Drug Administration (FDA) reclassified transvaginal mesh implants from Class II (moderate risk) to Class (III). This re-designation means that mesh makers now have to go through premarket approval, which requires submittal of safety data, in order to approve new mesh products.
When the plaintiff’s lawsuit went to trial, her attorney argued that the Pinnacle Pelvic Floor Repair Kit was too large and heavy to be implanted safely and difficult to remove in case of complications. According to Law360, the appeals court ruled that the trial judge improperly excluded information that appeared on the material safety data sheet (MSDS) for the polypropylene material used to make the mesh. The MSDS contained a warning stating that the mesh was not suitable for implantation, the plaintiff said in her appeal. The plaintiff also alleged that the judge should not have excluded letters from the FDA asking for post-market surveillance data.