Bard Avaulta Mesh Injury Lawyers
Missouri • Kansas • Southern Illinois
Vaginal wall prolapse is a painful condition. It is typically seen in women who have had hysterectomies. The vaginal wall becomes unstable and collapses into the vaginal cavity. Medical providers may recommend pelvic floor surgery to remedy this condition.
The Bard Avaulta Pelvic Floor Support Systems vaginal mesh products are designed to repair vaginal wall prolapse. They are marketed under the following brand names:
- Avaulta Plus BioSynthetic Support System
- Avaulta Solo Synthetic Support System
- Avaulta Anterior BioSynthetic Support System
- Avaulta Posterior Synthetic Support System
When the manufacturer, C.F. Bard, sought approval from the FDA for the Avaulta systems, it filed a "510(k)" application[1]. This process allows for medical devices to be fast-tracked for approval if they "substantially equivalent" to an already approved device[2]. The FDA granted this status in September of 2008. However, injuries to patients have caused questions about the safety of this product.
The FDA website has an "adverse event" reporting section, called MAUDE, where problems caused by a medical device or drug can be reported. Since 2008, there have been over 180 MAUDE reports about Avaulta, 40 in the first three months of 2011 alone.
Complications from mesh implants can include:
- Pain
- Infection
- Urinary problems
- Recurrence of vaginal wall prolapse
- Fistulas
- Bowel perforation
- Bladder perforation
The manufacturer's response has been to blame the surgeons who used this defective product. A typical response from Bard reads like this:
"The instructions for use states under precautions: 'the mesh should only be used by physicians who are trained in the surgical procedures and techniques required for pelvic floor reconstruction and the implantation of nonabsorbable meshes.'"
If you or a loved one has been harmed by a Bard manufactured Avaulta product, you may be entitled to compensation. The experienced lawyers at Brown & Crouppen provide tough, aggressive representation for victims and their families. Our attorneys are familiar with these serious injury cases and are ready to help.
Brown & Crouppen can help you make informed decisions about your legal rights, so please call us Toll-Free at: 1-888-891-2022 for your free legal consultation or save time with our online contact form.
[1] http://www.fda.gov/downloads/AboutFDA/CentersOffices/CDRH/CDRHFOIAElectronicReadingRoom/UCM249903.pdf
[2] http://www.fda.gov/BiologicsBloodVaccines/DevelopmentApprovalProcess/default.htm
