Transvaginal Mesh: “Women Are Suffering All Over the World”

Boston, MAChristine Asprey, a Canadian women whose life was turned upside down thanks to transvaginal mesh, is free from the device after revision surgery in California. But Asprey tells the Winnipeg Free Press that she is no better off without the mesh. In other words, even with the mesh removed from her body, Asprey is still suffering from complications.

According to the Winnipeg Free Press (9/14/13), the former hospital program assistant was in severe pain within three weeks of implantation of the transvaginal sling (TVT sling) to treat Pelvic Organ Prolapse (POP), and specifically prolapse of her bladder that caused incontinence. According to the report, Asprey once described the pain as a cheese grater “taking pieces of tissue off.”

Receiving the problematic TVT mesh in January 2012, she lived with the pain for 16 months before finally raising enough money through the generosity of friends to travel to Los Angeles for consultation with specialists this past April. She finally had the surgery to remove the mesh July 8 in California.

Nearly three months after the surgery, there are still problems and she remains worse off than she was before receiving the mesh to treat her POP in the first place. While she tells the Winnipeg Free Press she is relieved the mesh is no longer inside her, transvaginal mesh complication remains.

The TVT side effects that linger include nerve damage and the inability to drive. “If I drive, it kills me…” she says. While she can now walk without a cane, she is incapable of covering any substantial distance and remains in great pain. “Women are suffering all over the world,” said Asprey, in comments published in the Winnipeg Free Press. “This is not a joke; this is real.”

The transvaginal mesh lawsuit count in Canada is about 1,000 - women who have already initiated litigation or who have expressed interest in joining a class-action lawsuit. Those numbers are much higher in the US, given the hundreds of thousands of TVT sling procedures that have been done in the years since transvaginal mesh was approved by the US Food and Drug Administration (FDA). To that end, the number of lawsuits spiked over the summer as many litigants lined up to get into the pipeline prior to the expiry of the two-year limitation in several states.

Many jurisdictions hold that would-be plaintiffs have two years in which to file a lawsuit from the time the FDA issues a substantive warning about a product. According to the Boston Business Journal (7/12/13), the most recent FDA warning was issued July 13, 2011, and updated a previous warning issued three years prior to that - in 2008 - that acknowledged complications associated with TVT sling surgery using mesh, but that such complications were rare.

The 2011 warning was much more dire, suggesting that complications involving transvaginal mesh were not only possible and no longer rare, but that the FDA no longer held confidence that laparoscopic insertion and deployment of transvaginal mesh was safer and offered added efficacy over more traditional methods of treatment.

The federal gatekeeper for drugs and medical devices noted that about 10 percent of women with a mesh-based transvaginal tape sling experienced erosion of the mesh within 12 months of surgery. Complications also included pain, infection, bleeding, and pain during sexual intercourse, organ perforation and urinary problems. Manufacturers of mesh - more than 30 of them - were mandated by the FDA to undertake post-market analysis and safety of TVM mesh.

A few of the manufacturers have since abandoned the market entirely.

According to the Boston Business Journal, the statute of limitations in Massachusetts is three years, which gives potential litigants in that state until July 2014 to file. But many plaintiffs are filing early, and ahead of a bellwether case that is scheduled for January 2014 in Middlesex Superior Court. An attorney close to the case says about 16,000 lawsuits in total have been launched against six manufacturers of a product that was once considered a miracle product…

But no more.