Transvaginal Mesh Lawyers in Dallas
Public awareness has increased about the risk of transvaginal mesh- and still, these surgeries continue. In 2011, the FDA issued a warning indicating that transvaginal mesh does not appear to provide any benefit over other means of treatment for Pelvic Organ Prolapse (POP).
The Dangers of Transvaginal Mesh
While transvaginal mesh was developed to be an improvement over other surgical techniques, the opposite appears true:
- The FDA has recently warned that the complications associated with transvaginal mesh are “not rare” and “may expose patients to greater risk” than repairs performed without transvaginal mesh
- In 2007, a transvaginal trial consisted of 65 women who had been diagnosed with pelvis organ prolapse. After two years, the trial was suspended because the women experienced adverse effects. Within a period of only three months, researchers discovered that over 15% of women who had received a mesh implantation suffered from dangerous complications
- In 2010, more than 75,000 transvaginal mesh prolapse surgeries were performed and more than 10% (7,500) resulted in failure
- While the U.S. Drug Administration (FDA) received more than 1,000 reports from 2005-2007 of adverse events involving surgical mesh used to treat POP and stress incontinency, this number has tripled in subsequent years
- Patients may have to endure multiple surgeries to remove the device
- Public Citizen has called upon the FDA and manufacturers of transvaginal mesh to recall these devices
According to Drugwatch.com, “The most common problem associated with vaginal mesh implants is unfortunately the most dangerous. Transvaginal mesh erosion, also called mesh extrusions, occurs when the rough edges of the synthetic mesh cuts through the vaginal lining and nearby organs.” As a result, bleeding, infection, organ perforation, urinary problems and pain during intercourse can result. Because mesh often contracts or shrinks, once inside the vaginal area, this can cause vaginal shortening, tightening and pain. Other injuries according to the FDA, include:
- Neuromuscular problems
- Vaginal scarring
- Emotional problems
- Recurrent prolapses
Lawsuits that Have Been Filed
Despite these facts, in 2010, doctors performed more than 100,000 urogynecologic surgical procedures, 75% of which were performed transvaginally. As of May 2012, the number of lawsuits filed against transvaginal mesh manufacturers were as follows:
- 313 cases filed against Boston Scientific
- 457 cases filed against Johnson & Johnson’s Ethicon division
- 529 cases filed against AMS
- 740 cases filed against C.R. Bard
Doctor Expectations When Performing Surgeries
Individuals who filed lawsuits due to the adverse effects of a transvaginal mesh implantation, have been awarded up to $5 million in damages. The FDA has advises that physicians:
- Obtain specialized training for each mesh technique and be aware of its risks
- Be vigilant for potential adverse events from the mesh, especially erosion and infection
- Watch for complications associated with the tools used in transvaginal placement, especially bowel, bladder and blood vessel perforations
- Inform patients that implantation of surgical mesh is permanent, and that some complications associated with the implanted mesh may require additional surgery that may or may not correct the complication
- Inform patients about the potential for serious complications and their effect on quality of life, including pain during sexual intercourse, scarring and narrowing of the virginal wall (in POP repair)
- Provide patients with a written copy of the patient labeling from the surgical mesh manufacturer, if available
Get Zinda Law Group on your side today!
In 2011, the FDA committee, Obstetrics & Gynecology Devices Advisory Committee reviewed the dangers of mesh but declined to remove transvaginal mesh from the market. While the committee did call for tougher testing, reclassifying the device and premarket approval that will better ensure the safety and effectiveness of future devices, this problem has by no means been entirely solved.
If you underwent a transvaginal mesh operation and have since experienced mesh erosion or contraction, mesh exposure, formation of scar tissue or pain or bleeding of any kind, you should contact a personal injury attorney immediately to see how you too can file a lawsuit. Call Zinda Law Group today to get the qualified representation you deserve!