Six Defective Vaginal Mesh Implants Cited in New Lawsuit

An adoption of the long form master complaint was made by plaintiff Selena Denise Young, who filed her vaginal mesh lawsuit on September 17, 2012 with the MDL in West Virginia’s Southern District Court.

Vaginal mesh implant devices were first used in the treatment of hernias; now they have been recently used in the treatment of symptoms related to pelvic organ prolapse (POP), starting in the 1970s. About 20 years later, doctors discovered another use for transvaginal mesh: it could be used as a treatment for stress urinary incontinence.

However, following bladder sling implant surgery, numerous women began to suffer pelvic complications related to the mesh implant, such as pain, infections, scarring, organ perforation, urinary problems, and fistula.

A warning was issued by the FDA in 2011 regarding the complications related to the pelvic mesh implant. The FDA warned that complications brought with it dangerous adverse reactions such as erosion, pain, bleeding, protrusion, and infections, which were quite common and even numerous surgical procedures won’t help rectify the problems.

FDA Approved Vaginal Mesh through Fast-Tracking, Resulting in a Forego of Safety Testing Procedures

The vaginal mesh implant products did meet FDA approval, yet they skipped the normally mandatory trials ensuring their safety, despite the fact that scientific evidence proves incompatibility between polypropylene and human tissue.

Polypropylene is used in numerous vaginal mesh implants. The FDA’s 501(k) process or fast-track approval process was used by the agency to grant the devices approval, which allowed them to skip necessary safety testing. Eligibility of a product depends on similar products meeting approval. If a product that has previously been approved is very similar to the newer product, that newer product will automatically be approved through the FDA’s fast-track process. It goes by the dangerous assumption that if product A was approved, then product B should be approved, too. This also assumes that Product A and B are very similar.

A shocking 2012 congressional report discovered that under the fast-track approval process, a product is approved, even if its predecessor product was recalled. This indicates that a line of defective products are still on the market, as the FDA basically approved a defective product, because the product the new product is based was defective, was approved, and is still on the market and patients are still being implanted with them.

February Will See the First Vaginal Mesh Implant Lawsuit Trial

Hundreds of women are filing vaginal mesh implant lawsuits as a result of the establishment of four MDLs. These vaginal mesh lawsuits were combined into the MDLs against the various manufacturers named as defendants. Joseph R. Goodwin, Chief District Judge is overseeing the entirety of vaginal mesh lawsuit MDLs. February 5, 2013 is the schedule date for the first bellwether trial on the vaginal mesh.

Filing a Vaginal Mesh Lawsuit