A medical device manufacturer called American Medical Systems (AMS) has produced vaginal mesh devices that have been shown to cause potentially lifelong debilitating complications in patients. Many injured patients have brought lawsuits against AMS for its defective vaginal mesh implants.
Surgeons implant transvaginal mesh devices into patients to correct medical conditions such as stress urinary incontinence and pelvic organ prolapse. AMS is one of the largest manufacturers of transvaginal mesh devices in the United States, and the company's products have been implanted in thousands of persons.
Surgeons Commonly use Transvaginal Mesh to Help PatientsMany persons across the country have undergone procedures involving transvaginal mesh products to correct common medical conditions. Between the years of 2008 and 2010, affected persons made over 1,500 claims that transvaginal mesh devices malfunctioned or caused injuries. The Federal Drug Administration (FDA) received a five-fold increase in complaints regarding transvaginal mesh products between the years of 2005 and 2007.
According to publicly available data, approximately 300,000 women in the United States suffered from pelvic organ prolapse in 2010. Of those women, over 70,000 underwent procedures involving vaginal mesh. That same year, another 185,000 women received vaginal mesh implants in order to treat stress urinary incontinence. By July 2011, the FDA reported that another 2,874 more women had reported complications from vaginal mesh products over a two-year span.
AMS Transvaginal Mesh has Been Linked to Serious Injuries and ComplicationsAMS transvaginal mesh devices, like other mesh products, have been linked by claimants to a range of serious side effects and symptoms. The FDA has reported that it has received numerous reports that AMS transvaginal mesh products have caused injuries, infections, and pain. The following types of AMS transvaginal mesh products have been associated with injuries:
An FDA panel suggested that AMS transvaginal mesh be reclassified from possessing a moderate risk of harm to possessing a high risk of harm, after a device failure. Amid these concerns, in 2011 the FDA moved vaginal mesh products into the category of Class III medical devices. The FDA announced that additional studies would be undertaken regarding the safety and effectiveness of vaginal mesh products. The FDA also mandated pre-market clinical testing for any new types of transvaginal mesh products.
Before the FDA changed the classification level of transvaginal mesh, medical device companies only needed to show that their new transvaginal mesh products were substantially equivalent to existing transvaginal mesh products in order to sell them on the open market. In 2019, the FDA ordered all surgical mesh manufacturers to immediately stop selling and distributing their products.
Sadly, if transvaginal mesh manufacturers had conducted proper clinical studies before releasing their medical devices to the public, many of the dangerous side effects of these products could have come to light sooner. More women could have avoided suffering what are often life-long complications.
AMS Transvaginal Mesh Devices Have Been Associated With Serious ComplicationsMany patients who have received AMS transvaginal mesh devices have reported dangerous complications, including serious injuries and deaths. Sadly, many women who suffer complications from AMS transvaginal mesh have required additional surgery to remedy their injuries. Women who have suffered perforation of organs, including the bladder, the bowel, or the urethra, have required corrective surgery to ameliorate their pain and other symptoms. When perforations occur, the risk of infection increases greatly. Some women have experienced dangerous septic shock because fecal matter or urine has traveled into the tissue around the perforation, causing sepsis.
Additionally, when the mesh product erodes in the tissue, it can cause severe pain, lacerations in the surrounding tissue, and a risk of dangerous infection. Many persons who suffer from eroding vaginal mesh have reported that they are no longer able to engage in everyday activities. Some patients experience so much pain that they find it difficult to even walk around the house. Unfortunately, revision surgery does not always solve the problem. Even persons who received a revision surgery to fix the problems associated with a defective transvaginal mesh device may continue to suffer pain, permanent incontinence, and other debilitating symptoms.
Lawyers Help Persons Seeking Compensation For Injuries Related to Transvaginal MeshIf you or your loved one has suffered injuries due to a defective AMS transvaginal mesh device, the injured person may have a right to compensation for one's injuries. Under North Carolina law, victims of defective medical devices have a right to bring a product liability lawsuit against the manufacturer of the defective medical device. The sooner an affected person speaks to an experienced Charlotte product liability lawyer, the better the odds are that the person will win the compensation one deserves. The professionals at Arnold & Smith, PLLC offer potential new clients a free initial consultation. Contact us today to schedule your appointment.