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Have you had a Transvaginal Mesh Implant?
You may be eligible for compensation.
Symptoms you may be experience with
- Mesh Erosion
- Stress Urinary Incontinece
- Vaginal Shrinkage
- Vaginal Scarring
- Organ Perforation
- Pain During Intercourse
- Recurrent Prolapse
- Neuromuscular Problems
Facts about Transvaginal Mesh:
Transvaginal Mesh is a type of surgical mesh used to treat pelvic organ prolapse, bladder prolapse, stress urinary incontinence, and similar problems. According to the FDA, nearly 40 percent of women between the ages of 35 and 54 suffer from SUI. In 2010, more than 10,000 women underwent vaginal mesh surgery to repair pelvic organ prolapse.
During a surgical procedure, the mesh is implanted in the vagina and used to create what is called a pelvic or bladder sling. The mesh is also utilized to reinforce the vaginal wall.
Recently the FDA has received an increasing number of adverse event reports regarding transvaginal mesh. Reported complications include mesh from nine different manufacturers. The most common complications reported to the FDA from 2008-2010 include:
In August 2010, the medical journal Obstetrics & Gynecology reported that researches were forced to stop a transvaginal mesh clinical trial early because women implanted with the mesh experienced too many complications. Specifically, 65 women with pelvic organ prolapse underwent surgery using the pelvic mesh or an alternative procedure known called colpopexy that uses ligaments to help support the pelvic muscles. The trial was cut short after researchers found that more than 15 percent of the women implanted with the mesh suffered mesh erosion within only three months after implantation.
On July 13, 2011, the FDA issued a Safety Communication intended for health care providers, physicians, and patients who have undergone the transvaginal mesh procedure or who are considering the surgery. In the communication, the FDA warned of the risks associated with the use of the mesh and recommended considering alternatives for treating pelvic organ prolapsed and stress urinary incontinence.
In September 2011, the FDA issued a recall of several transvaginal mesh products. Specifically, the FDA recalled Boston Scientific Corporation’s Pinnacle Pelvic Floor Repair Kit--Anterior/Apical STERILE and Pinnacle Pelvic Floor Repair Kit--Posterior STERILE because they could exhibit low tensile strength between the needle and suture and lead to needle detachment during placement.
An FDA advisory panel also met during that time period to discuss the safety of medical devices in general, including transvaginal mesh. The panel recommended tougher pre-market testing of vaginal mesh products and reclassifying the devices to a Class III—the highest-risk category for medical devices—without recalling existing products.
Are you eligible to receive compensation?
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