Transvaginal Mesh plastic implants are also referred to as a pelvic sling, bladder mesh, or transvaginal mesh vaginal mesh support systems. These medical products, the transvaginal mesh vaginal mesh support systems are used to fix pelvic organ prolapse and stress urinary incontinence, and have now been found to cause serious internal injuries in women.
These transvaginal mesh patch implants, manufactured by Johnson & Johnson, C.R. Bard, Boston Scientific, American Medical Systems, and others, may cause pain, infection, erosion, organ damage, and corrective surgeries, among other vaginal mesh injuries.
If you have experienced vaginal mesh complications following pelvic organ prolapse surgery or stress urinary incontinence surgery, our vaginal mesh lawyers may be able to help you pursue significant compensation for the vaginal mesh problems you are experiencing.
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The Food and Drug Administration (FDA) has issued Public Health Notifications concerning the use of vaginal mesh products or bladder slings for the treatment of Stress Urinary Incontinence and Pelvic Organ Prolapse.
The July 13, 2011 FDA warning, urged patients and their healthcare providers to consider alternatives to transvaginal mesh (TVM). TVM is a medical device implanted surgically to treat Pelvic Organ Prolapse (POP) and Stress Urinary Incontinence (SUI). In 2010, more than 75,000 women had vaginal mesh surgery to repair POP.
Recent research shows that at least 10% of women who have received TVM implants suffer from mesh erosion within 12 months of surgery and more than half of these patients require additional surgery to remove the mesh following complications.
The advisory also noted that the FDA will be meeting on September 8-9, 2011 to discuss a potential ban on the mesh. The FDA was prompted to issue this warning after receiving more than 3,875 injury reports associated with the mesh, three of which involved fatalities, from 2005 to 2010.
Complications from Bard Avaulta vaginal mesh may cause severe pain and permanent injury that can have a devastating impact on women. The Bard Avaulta lawyers at the Dr Shezad Malik Law Firm are investigating potential lawsuits for women who were implanted with a Bard Avaulta mesh to treat pelvic organ prolapse (POP) and who have experienced complications following surgery with the Bard Avaulta system.
Bard Avaulta mesh lawsuits are being evaluated and reviewed for women who have experienced:
On October 20, 2008, the U.S. Food and Drug Administration issued an FDA Warning regarding complications associated with trans-vaginal placement of surgical mesh, including Bard Avaulta surgical mesh. The Bard Avaulta FDA Warning stated that, it has received more than 1,000 reports from nine surgical mesh manufacturers of complications that were associated with surgical mesh devices used to repair Pelvic Organ Prolapse and Stress Urinary Incontinence. Among the surgical mesh products associated with complications are the Avaulta Biosynthetic Support System and Avaulta Plus Biosynthetic Support System, both of which are manufactured by Bard.
Bard Avaulta Mesh Side Effect and ComplicationsThe Bard Avaulta Biosynthetic Support System, referred to as Bard Avaulta Mesh is a vaginal mesh created by C.R. Bard to correct and restore normal vaginal structure after a pelvic organ prolapse. A number of women treated with the Bard Avaulta system have claimed that defects in the design of the vaginal mesh caused them to suffer severe injuries and complications after surgery.
Synthetic mesh systems like the Bard Avaulta have been associated with numerous reports of problems, involving erosion, extrusion, infection, hardening of the mesh, chronic pain and damage to surrounding organs.
Although the manufacturer, C.R. Bard, knew or should have known about the risk of problems with Bard Avaulta mesh, they continued to market and promote the product as a safe and effective for treatment of pelvic organ prolapse, while minimizing the risks of a Bard Avaulta procedure.
The Bard Avaulta is designed to allow tissue infiltration, which makes it complicated to remove the vaginal mesh. Removal of eroded or infected Bard Avaulta mesh poses a risk of permanent disfigurement, hemorrhage and other potentially life-threatening problems.
Bard Avaulta lawsuits allege that C.R. Bard was negligent in the design and sale of the Avault system. Since the vaginal mesh was introduced, the manufacturer knew or should have known that the Bard Avaulta mesh was defective and could lead to erosion, hardening and shrinkage of the mesh materials and other complications that may have a devastating impact on women.
Despite the known risks of Bard Avault procedure complications, the manufacturer failed to adequately research the product and establish that it provides both long term and short term efficacy. In addition, they concealed known risks and failed to warn of the dangers and risks with Bard Avaulta mesh for pelvic organ prolapse.