If you have never heard of vaginal meshes, it is probably a good thing. Vaginal meshes are medical devices designed to help women whose organs drop from position, a common problem after childbirth. The mesh is designed to hoist the organ back into place (think of a hammock strung between two trees). Unfortunately, unknown to the 1000s of women who agreed to allow them to be implanted, the mesh can erode, cause scarring and has even been alleged to have caused organ perforation. As a result, some women with meshes end up requiring 10 or even more corrective surgeries, and many are told “there is nothing we can do.” Thus, they must live with the intense pain, and inability to have intercourse absent extreme pain, not to mention other effects.
Over 650 lawsuits have been filed against the makers of the mesh, and on July 23, 2010, a jury in California awarded $5.5 million to a California couple in one of the first cases to go to trial. Christine Scott, a formerly avid runner, had a mesh installed to correct a leaky bladder. The mesh soon began cutting into her colon and tissue continued to grow through tiny holes in the mesh,causing intense pain. After eight surgeries, she is still in tremendous pain.
As to the fact that the device has been FDA-approved, Ms. Scott’s lawyer noted that “[t]hey tested this on 16 rats, 12 rabbits, four sheep and, by their own researcher’s admission, the next living being this product went into was women.” For its part, the manufacturer continues to rely on the fact that the device is FDA-approved. Good point: do not assume that simply because a medical device or drug is approved the FDA that it cannot be dangerous.
Meanwhile, Ms. Scott who was under a gag order during the trial noted that “[t]he hardest part, I will tell you, though this whole thing, is having to keep quiet,watching women still get hurt.” It will be interesting to see what the manufacturer does for the affected women going forward. Admit its mistake, and help them? Or fight, fight, fight?