Monmouth County Transvaginal/ Pelvic Mesh Complication Lawyer
Representing NJ clients facing injury caused by transvaginal mesh
When transvaginal mesh was introduced to the market in the late 1990’s, it was touted as an easier fix for prolapsed and incontinence compared with traditional surgery. In the procedure, doctors surgically implant a piece of synthetic mesh through the vagina to support organs that have prolapsed, or fallen out of place. To treat incontinence, doctors use a smaller piece of mesh known as a bladder ring. Within weeks or months of the mesh being implanted, medical problems typically start to crop up.
Women have reported:
- Urinary problems
- Vaginal bleeding
- Recurrent prolapsed
- Perforation of the bladder, intestines and uterus
In addition, women and their partners have reported sexual dysfunction as a result of the mesh. In many cases, patients must have the mesh surgically trimmed or removed. The removal process can require three or more revision surgeries. The FDA has said that 10% of women experienced erosion or exposure of the mesh within 12 months of having the mesh implanted. More than half of these women require follow-up surgery to remove the mesh.
FDA acknowledges rise in mesh complications
In 2008, the FDA caused an uproar when it acknowledged problems with transvaginal repairs, but claimed mesh complications were rare. However, between 2008 and 2010, the FDA received more than 1,700 reports of injuries or complications involving pelvic organ mesh repair kits. In 2011, the agency reversed its decision and said complications were in fact not rare, noting that issues arise in 10 percent of transvaginal mesh prolapsed patients within a year of surgery. From 2005 to 2010, the agency received nearly 4,000 reports of complications related to transvaginal mesh products, including three deaths. In 2011, the FDA issued an update recognizing the problems with transvaginal mesh were more serious than they thought. They reported: “serious complications associated with surgical mesh for transvaginal repair of pelvic organ prolapsed are not rare.” They also stated that it is not clear that transvaginal repair with mesh is more effective than traditional non-mesh repair and it may expose patients to greater risk. When the FDA’s advisory committee panel refused to recommend a recall, but is considering reclassifying transvaginal mesh as a Class III device, which would require stringent premarket testing before widespread distribution.
Lack of safety testing
Mesh products were initially seen as a high-tech improvement over traditional surgery. Since similar mesh was already used in other surgery, the products received fast-track approval from the FDA without the tests that agency requires for first time devices. Therefore, no safety testing was done, and the companies failed to inform the medical community of the potential for the harm. It’s unclear what the FDA will do at this point. The agency usually follows its advisory committee recommendations and has ordered 40 mesh manufacturers to conduct safety reviews of their products. Even with that, legal and governmental spotlights on transvaginal mesh may force the FDA to take a harder stance. If you or a loved one have undergone a revision surgery after one of these products and would like more information on your legal rights, please contact us.
Update on the status of lawsuits regarding TVM and pelvic mesh
There are currently more than 60,000 lawsuits pending due to these horrific injuries women face now and will face in the future. Several multi-million dollar verdicts have come back, not only for compensatory damages but also for punitive damages, based on the faulty research and marketing of these products. Most recently, a jury awarded $100 million against Boston Scientific, which included a $75 million punitive verdict. To date, 16 plaintiffs have received jury verdicts and the manufacturers have won 3. There have been a few settlements; however, multiple trials are scheduled for the coming year.
Contact a Freehold attorney with faulty medical device experience
If you are suffering from complications from transvaginal mesh products, you need an attorney to protect your future. You could face a multitude of complications that were caused by this faulty device. Tomes & Hanratty, P.C. has decades of experience working with clients who are victims of negligence. If you need our legal support, contact our firm immediately. We are here to serve.