Ethicon Prolene Mesh is a synthetic monofilament suture used to treat hernias, pelvic organ prolapse (POP), and stress urinary incontinence (SUI). Unfortunately, despite originally being considered a revolutionary breakthrough in medical device technology, Prolene Mesh has recently been associated with complications including mesh erosion, infections, pain, dyspareunia, organ perforation, and the recurrence of urinary problems. Prolene Mesh is also extremely difficult to remove once it has been implanted, meaning that women who are injured by the device may not ever be able to fully recover.
Prolene Mesh Complications
The dangers of Ethicon Prolene Mesh products have come to the public’s attention over the last few years, as more and more women implanted with the devices have reported adverse health complications. In 2011, the U.S. Food & Drug Administration (FDA) warned that between 2008 and 2010, it received more than 1,500 injury reports associated with transvaginal mesh, which included instances of:
- erosion through vaginal epithelium
- pain, including dyspareunia
- urinary problems
- recurrence of prolapse and/or incontinence
- bowel, bladder, and blood vessel perforation
- vaginal scarring
- mesh erosion
In addition to these Prolene Mesh complications, there have been reports of recurrent prolapse, neuromuscular issues, vaginal scarring/shrinkage, as well as mental and emotional problems in women implanted with the devices. Unfortunately, many of these complications may require revision surgeries, emergency medical intervention, and extended hospital stays. According to a July 2011 Safety Communication issued by the Food & Drug Administration:
“The FDA’s literature review found that erosion of mesh through the vagina is the most common and consistently reported mesh-related complication from transvaginal POP surgeries using mesh. Mesh erosion can require multiple surgeries to repair and can be debilitating for some women. In some cases, even multiple surgeries will not resolve the complication.”
The warning went on to state that transvaginal mesh complications have been reported to include serious pelvic pain, pain during intercourse, and the inability to have sex. Additionally, men may suffer irritation and pain in the penis during intercourse when surgical mesh is exposed.
Are Prolene Mesh Lawsuits Being Filed?
A federal Ethicon Transvaginal Mesh Multidistrict Litigation (MDL) is currently underway in the U.S. District Court, Southern District of West Virginia. According to court documents, a number of Prolene Mesh products are named in the suits, including:
- Prolene Mesh/Prolene Soft Mesh
- Gynemesh PS,
- Gynemesh TVT
- TVT Exact
- TVT Abbrevo
- Prolift + M