The number of women seeking legal recourse because of problems with surgically implanted transvaginal mesh is growing exponentially. Complications from transvaginal mesh were first reported by the FDA in 2008, when the agency made it known that more than 1,000 complaints had been registered against nine different manufacturers over the previous three years. Then, from 2008 to 2010, the FDA received more than 1,500 reports of complications from recipients of the mesh, five times the amount it logged from 2005 to 2007.
Transvaginal mesh is a medical device implanted in women who suffer from pelvic organ prolapse or stress urinary incontinence. It is made of porous material, either synthetic or biological, and it is meant to repair weak and/or damaged tissue. A common problem reported with transvaginal mesh is that the synthetic material has sharp edges that cut into the tissue, and can penetrate the bladder, uterus, and bowel. Patches of the implanted mesh do not stay in place, moving around the tissue and causing damage. Some forms of the synthetic mesh are petroleum-based, and petroleum is a substance that attracts and breeds bacteria. Infections due to petroleum-based transvaginal mesh have led to chronic problems such as incontinence, UTI, back pain, and sensations of lower body paralysis. Death has occurred from severe infections due to transvaginal mesh.
Reported symptoms from women with implanted transvaginal mesh include bleeding, vaginal scarring, painful intercourse, mesh erosion, general pain and discomfort, tissue and blood vessel perforation, infections, and urinary problems.
Removing transvaginal mesh is problematic. Some women attempt multiple surgeries for complete removal, but the mesh material often fuses itself to the vaginal tissue, causing chronic health problems to the recipient for life.
Lawsuits filed by recipients of transvaginal mesh allege that manufacturers of the medical device provided false and misleading information about the safety of their product, and the companies neglected their legal duty to communicate the safety and effectiveness of the mesh. Additional allegations of lawsuits against the mesh manufacturers are fraud, concealing potential harm caused by the product, intentionally misleading the FDA, medical community, and public about product safety, failing to conduct proper testing to determine risks, failing to provide safe and effective means of removal, and failing to warn of possible complications and injury. Plaintiffs are seeking compensation for pain and suffering and medical bills, among other losses and damages.
The FDA has determined that severe complications for women who have received transvaginal mesh are not rare. At least ten deaths have been reported from problems related to transvaginal mesh. Reports of serious complications are expected to escalate even further because 100,000 transvaginal mesh implants are conducted annually. The FDA reports indicate potentially tens of thousands of injuries will be recorded, and possibly hundreds of deaths from complications tied to transvaginal mesh.
Any person affected by health problems due to transvaginal mesh should contact an attorney as soon as possible, as some states have time limitations on transvaginal mesh claims and awarding compensation to those who may be suffering.
Article Type: LawsuitTopic: Patient Care