Pelvic organ prolapse and stress urinary incontinence are relatively common medical conditions among adult women. According to the U.S. Food and Drug Administration, millions of American women are affected by these conditions. In most cases, they occur because the pelvic muscles have weakened, allowing the bladder to sink and press against the vaginal wall.
For many women, this condition has been addressed through the surgical implantation of a transvaginal mesh - basically, a piece of woven fine wire mesh that is used to reinforce and support the damaged tissue. Unfortunately, transvaginal mesh has been linked to a number of serious and painful complications.
Between 2005 and 2010, the FDA received nearly 4,000 reports of adverse events involving complications from transvaginal mesh. Some of the most common reported complications included the following:
- Severe pain
- Infection of the implantation site
- Erosion of the mesh into the vaginal tissue
- Recurrence of prolapse or incontinence
- Urinary problems
- Neuromuscular problems
In some instances, these problems can be corrected with revision surgeries. In others, surgical intervention is ineffective and women are forced to live with pain and other complications.
Transvaginal mesh lawsuits
In the wake of these problems, a number of product liability lawsuits have been filed against manufacturers of transvaginal mesh. In February, the first jury verdict was reached. In that case, a jury awarded $3.35 million to a woman who had the mesh implanted to treat a pelvic organ prolapse. She ended up experiencing severe complications and had to undergo 18 surgeries to correct the problem.
The woman sued Johnson & Johnson and its subsidiary Ethicon (the manufacturer of the mesh at issue in her case) claiming that the companies misrepresented the dangers of the product and that she was not adequately warned about what could happen. She further claimed that the product was defective both in its design and in its manufacturing.
Though this was the first case to be tried by a jury, approximately 11,000 other cases are pending against a variety of manufacturers. (In addition to Johnson & Johnson, other major transvaginal mesh manufacturers include C.R. Bard, Boston Scientific and American Medical Systems.) Many of these cases are part of consolidated multi-district litigation arrangements. Though each case is unique, February's verdict is expected to set the tone for upcoming trials and settlement negotiations.
Women who were injured by transvaginal mesh would be wise to discuss their cases with an experienced personal injury attorney who can help them understand if they qualify to take action against the product's manufacturer. No one should be forced to live with the consequences of what happens when medical device manufacturers put profits over patient safety.