Pelvic Prolapse Surgery Injury Lawyers
Many persons suffer from a condition known as pelvic organ prolapse, in particular persons who have given birth to a child. Pelvic organ prolapse is a condition that occurs when organs in a woman's pelvic region begin to weaken or loosen. The bladder, the cervix, the small bowel, and the urethra can all be subject to prolapse. Serious pelvic organ prolapse cases can cause pressure on the abdomen, significant pain, and a feeling that pelvic organs are pushing out of the rectum or the vagina. In some cases, a patient must undergo surgery to treat pelvic organ prolapse. By the age of eighty (80) years, as many as ten-percent 10% of women throughout the United States will have received medical treatment for pelvic organ prolapse.Vaginal Mesh Can Cause Complications, Injuries, Leading to Claims
Traditionally, medical treatment providers have treated prolapse by applying sutures to a patient’s pelvic muscles and ligaments. Since 2000, surgeons have in increasing numbers used synthetic—or medically manufactured—transvaginal mesh implants to repair pelvic organ prolapse. Currently over one-hundred 100 different models of manufactured vaginal mesh products are available on the market.
The Food and Drug Administration has issued warnings regarding the safety of these pelvic mesh devices. The FDA has pointed to risks of inflammation, infection, and of erosion of the devices within patients’ bodies.
Surgeons use manufactured vaginal mesh products by implanting them across the vagina in order to strengthen a weakened vaginal wall. Surgeons also use vaginal mesh devices to reinforce the urethra. Most vaginal mesh products are made from polypropylene or polyester. Notwithstanding the claims of medical device manufacturers that vaginal mesh implants are safer than traditional surgery, thousands of claimants have alleged that vaginal mesh has caused significant complications. These complications have included:
- Excessive vaginal bleeding;
- Recurrence of pelvic prolapse;
- Organ perforation;
- Scarring of the vagina;
- Erosion of vaginal mesh;
- The need for multiple revision surgeries in order to remove a failed mesh device.
Complications related to transvaginal mesh failure can severely harm patients. When pieces of the transvaginal mesh become embedded in tissue, surgeons may undertake revision surgery to remove faulty mesh. Even after revisions, many women still experience constant pain that prevents them from enjoying their lives and engaging in normal day-to-day activities. Many claimants have alleged that their transvaginal mesh device has caused them to become permanently incontinent. Still others have lost the ability to engage in sexual intercourse due to complications arising from their transvaginal mesh device.Manufacturers Who Have Produced Defective Vaginal Mesh Products Face Claims
Many different major medical and pharmaceutical companies have produced vaginal mesh devices. Johnson & Johnson, Boston Scientific, Coloplast, C.R. Bard, and American Medical Systems have all produced synthetic vaginal mesh products that claimants have linked to serious medical complications. All of these companies have faced claims from persons alleging that they failed to adequately warn about the risks and dangers associated with synthetic vaginal mesh.Common Complications With Vaginal Mesh Products Lead to Claims
Even as persons began bringing hundreds and thousands of claims regarding vaginal mesh, medical device manufacturers continued to claim that the risk of injury was low. However, the FDA issued multiple Public Health Notifications addressing the seriousness of transvaginal mesh complications. At one point, the FDA reported receiving some 1,000 complaints regarding adverse complications from transvaginal mesh devices between the years of 2005 and 2007. In 2019, the FDA issued a directive requiring manufacturers of pelvic mesh devices to cease selling the devices until more research could be conducted into their safety.
In one of its public updates, the FDA reported that “serious complications associated with surgical mesh for transvaginal repair of POP are not rare. Furthermore, it is not clear that transvaginal pelvic organ prolapse repair with mesh is more effective than traditional non-mesh repair in all patients with COPD. It may expose patients to greater risk.”
The evidence of serious complications arising from vaginal surgical mesh has caused the FDA to advise surgeons and other healthcare providers that “ in most cases, POP can be treated successfully without mesh, thus avoiding the risk of mesh-related complications.”Contact Our Transvaginal Mesh Injury Lawyers Today for Help With Claim
If you or a loved one has suffered complications or injuries caused by transvaginal mesh devices, our Charlotte product liability lawyers are here to help. We offer all of our potential clients a free initial consultation. Contact our Charlotte Law Firm today to schedule a free initial consultation.