Vaginal Mesh Failure
For some women, the pain from faulty vaginal mesh starts quickly after surgery. For others, it takes weeks or months for the pain to begin. But thousands of women who undergo vaginal mesh surgery to fix pelvic organ prolapses (POPs) or urinary incontinence, the pain is undeniable – it's relentless and unyielding pelvic pain that simply won't go away.
According to the U.S. Food and Drug Administration (FDA), an increasing number of women who have undergone mesh surgery end up with severe complications. The mesh is typically used to fix organs that have prolapsed as a result of menopause, a hysterectomy or childbirth. Mesh is also used to prop urinary bladders that are prone to leakage, called incontinence.
Incredibly, some studies, including those done by the FDA, have found that using mesh to repair transvaginal POP, does nothing to improve the comfort and prognosis women can expect from traditional methods used to treat this condition. In short, the mesh causes more problems than it fixes.
In 2010, an estimated 300,000 women underwent surgical mesh repair fixes for POP and another 260,000 had mesh surgery to fix urinary incontinence. The FDA said thousands of women have come forward to report subsequent injuries.
Vaginal Mesh Erosion
The most serious and common resulting injury from mesh placement is mesh erosion or protrusion through the vaginal wall. The mesh devices, which are made by a variety of manufacturers, are constructed from flexible plastic in a hammock shape. After it is surgically implanted to hold up prolapsed organs, the plastic is known to erode into nearby tissue including the bladder, rectum and vagina. This erosion can cause severe pain, infection, urinary tract problems, uncontrolled bleeding and organ damage.
Even the surgery to remove or excise the mesh can be dangerous. Studies show that mesh removal surgery can take multiple tries because only small amounts can be removed at one time.
In early 2011, the FDA reversed its initial decision about vaginal mesh and formally acknowledged ongoing problems the devices. The federal agency said that problems with mesh are not rare.
The resulting outcry has been heard around the world. In 2011, a study in the Journal of Obstetrics an Gynecology Canada recommended that pelvic mesh procedures be considered experimental and restricted to only investigative trials despite the devices being on the market for years. The FDA also issued a safety warning to patients and medical professionals.
Vaginal Mesh Lawsuits in Federal Court
Nationwide, injured women have turned to the court system for financial compensation for their injuries. They are outraged that medical device companies continued to sell the faulty mesh despite limited clinical trials and known risks.
Already, hundreds of women have sued C.R. Bard, Johnson & Johnson's Ethicon division, American Medical Systems and Boston Scientific. So far, nearly 600 cases have been consolidated into four ongoing multidistrict litigations (MDLs) in the U.S. District Court in West Virginia. The first test trials, called bellwether trials, are scheduled to begin in early 2013 in some of the Bard cases. The results from these trials will allow attorneys to determine future trends in the lawsuits.