Women Tells of Mentor ObTape HorrorsMay 6, 2008 | Parker Waichman LLP
Mentor’s ObTape Vaginal Sling is a medical device meant to stop the uncontrollable flow of urine as a result of urinary stress incontinence, a medical condition affecting about two million American women. Patients with urinary stress incontinence are no longer able to control or stop urine flow, which often happens in the years following childbirth. Approximately 35,000 women were implanted with Mentor Corporation’s ObTape and, now, women are reporting that the tape has deteriorated in their bodies and is making them ill and causing severe pain and other complications.
ObTape is a piece of mesh that is inserted as a type of sling that tapes up the bladder to prevent leaking. The Mentor ObTape Vaginal Sling is designed to replace eroded or weakened muscles in the urethra and is essentially a hammock for the vaginal wall. The vaginal sling technique has been around for about 100 years and is considered the “gold standard” in stress urinary incontinence treatment. Generally, the minimally invasive treatment can be done on an outpatient basis.
Meanwhile, one woman who has filed a lawsuit against Mentor Corporation, reports that following implantation of the mentor ObTape Vaginal Sling, the tape moved out of place and started to disintegrate inside her. When she became ill, doctors removed the sling, piece by piece, which left her with a large leg wound. Also, a medical study examined 67 patients and found that over 13 percent of patients experienced similar complications as well as impaired healing, vaginal extrusion, and urinary tract erosion that causes extreme vaginal pain, discharge, and infections, not to mention that the sling did not correct the original problem in many of the woman. Another eight developed a chronic vaginal discharge and one patient developed an abscess of the left thigh that tracked to the incision site. The study compared these patients to 56 others who had received another brand of vaginal sling. None of those patients experienced the complications seen with the Mentor ObTape Vaginal Sling.
Some believe Mentor misled the Food & Drug Administration (FDA) when it applied for what's called 510K status, which means it claimed that its product was so similar to ones already on the market it didn't need complete testing. Many believe the FDA was not as diligent as it should have been with the Mentor ObTape Sling.
Dr. Jaime Sepulveda is a national expert in pelvic floor medicine and reports he has always been skeptical about Mentor's ObTape because, unlike similar products on the market, it had different dimensions and hole sizes and it should have received separate Food and Drug Administration (FDA) approval. The non-woven design of the Mentor ObTape Vaginal Sling blocked much-needed oxygen and nutrients while woven vaginal slings produced by other companies allow oxygen and nutrients to pass through.
Currently, there are a variety of lawsuits against the Mentor Corporation as more women come forward claiming that ObTape migrated inside their bodies, disintegrated, and required surgical removal. Mentor no longer makes ObTape and within three years of the Mentor ObTape Vaginal Sling going on the market in 2003, the defective medical device was removed.