Transvaginal Mesh

Recent FDA warnings and side effect studies have indicated that transvaginal mesh medical devices, like Bard Avaulta mesh, may be linked to serious side effects like surgical mesh infection and erosion of the mesh into the vaginal tissue. Millions of women suffer from painful and embarrassing conditions, like pelvic organ prolapse (POP) and stress urinary incontinence (SUI), caused by weakened or damaged pelvic floor muscles, tissues and ligaments. Transvaginal mesh is a type of medical device used to treat these conditions, which are particularly common in women who have had multiple large pregnancies or women who have undergone a hysterectomy. Many women suffering from POP or SUI opt for transvaginal implantation of surgical mesh because it is minimally invasive and has been considered one of the top surgical treatments for POP and SUI repair. Unfortunately, recent information suggests that transvaginal mesh devices like Bard Avaulta may pose a significant danger to patients, potentially resulting in severe and debilitating side effects. In fact, the FDA recently indicated that transvaginal placement of surgical mesh may carry more risks than other treatment options, without any evidence of greater benefit. If you received a transvaginal mesh implant to repair POP or SUI and have since suffered from a major side effect, contact a transvaginal mesh attorney to discuss your legal options.

Transvaginal Mesh Uses

Transvaginal mesh is made from porous absorbable or non-absorbable synthetic material, or absorbable biologic material, and is permanently implanted to reinforce the weakened vaginal walls in women with POP or to support the urethra or bladder neck in women struggling with SUI. Pelvic organ prolapse is a serious condition in which one or more pelvic organs, like the bladder or uterus, slip from their normal position and put pressure on the vagina. Stress urinary incontinence describes the involuntary leakage of urine occurring during physical activity, like coughing, sneezing, laughing or exercising. Because POP and SUI can cause significant discomfort and pain, many women suffering from these conditions opt for surgical repair using transvaginal mesh. Unfortunately, transvaginal mesh may no longer be considered safe for the treatment of POP or SUI, due to potential transvaginal mesh side effects.

Potential Side Effects of Transvaginal Mesh

Recent FDA warnings have indicated that transvaginal mesh devices like Bard Avaulta mesh may be associated with significant side effects which can severely harm affected women. Among these potential transvaginal mesh side effects are surgical mesh infection, erosion of the mesh into the vaginal tissue, recurrence of POP and/or SUI, bladder, bowel and blood vessel perforation, injury to nearby organs, urinary problems, and pain during sexual intercourse. Due to the severity of potential transvaginal mesh side effects, the FDA has recommended that healthcare providers obtain specialized training for each mesh placement technique, and be aware of the risks of surgical mesh. Healthcare professionals should be vigilant for potential adverse side effects from the mesh, especially erosion and infection, and should inform patients about the potential for serious complications and their effect on quality of life.

FDA Warnings for Transvaginal Mesh Side Effects

In 2008, the FDA issued a public health advisory warning the public about the complications associated with transvaginal placement of surgical mesh to treat POP and SUI. At that point, the FDA had received more than 1,000 reports over the previous three years alone from nine surgical mesh manufacturers of complications associated with surgical mesh devices used to repair POP and SUI. The FDA indicated that the most frequent complications included erosion through the vaginal tissue, pain, infection, urinary problems, and recurrence of prolapse and/or incontinence.

In July 2011, the FDA issued an additional warning to patients and healthcare professionals indicating that the serious complications associated transvaginal mesh are not rare. The agency also reported that it is not clear that transvaginal POP repair with mesh is more effective than traditional non-mesh repair in all patients with POP, and it may actually expose patients to greater risk. Some of the serious side effects potentially linked to transvaginal mesh devices like Bard Avaulta may even require removal of the defective mesh, which is extremely dangerous given that surgical mesh implantation is intended to be permanent. Women who require transvaginal mesh removal may suffer from significant complications resulting from surgery, including hemorrhage, scarring of the pelvic tissues and muscles, and even permanent disfigurement.

Legal Help for Transvaginal Mesh Side Effects

Transvaginal mesh products are currently categorized by the FDA as Class II medical devices, which means that manufacturers are only required to show that the device is "substantially equivalent" to an existing device on the market, without requiring preclinical testing. If you or a loved one has suffered from a serious side effect, and you believe transvaginal mesh to be the cause, contact a transvaginal mesh attorney to discuss your options for legal recourse. You may have grounds to file a transvaginal mesh lawsuit against the manufacturing company responsible for the product, in order to seek financial compensation for your injuries, medical expenses, and pain and suffering. You are not at fault for any injuries caused by a defective consumer product, and you should not be held accountable for the resulting consequences. With the help of a qualified transvaginal mesh lawyer, victims of potential transvaginal mesh side effects can protect their rights and collect the compensation they deserve.

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