(June 6, 2012)
Hundreds of thousands of women suffer from a condition called pelvic organ prolapse (POP) and stress urinary incontinence (SUI). POP is diagnosed in patients where the tissue that supports the pelvis becomes weak and loses elasticity, causing the organs to “bulge” through the vagina. Prolapse can occur in women who have undergone childbirth, or from menopause, or occasionally as a result of hysterectomy surgery. The transvaginal mesh was implanted in these patients to help support the damaged, weak tissues, and act as a “hammock” to support the bladder in women suffering from stress urinary incontinence. The mesh is sometimes referred to as a bladder sling.
In severe cases of pelvic organ prolapse (POP), the “prolapse” is when the female organs protrude from the vaginal opening. It is extremely uncomfortable, embarrassing, depressing, and can cause infection if not treated. There is no choice but surgical repair to treat this condition.
Some physicians used transvaginal surgical mesh, which cannot be reabsorbed by the body. Many women have had this procedure performed successfully without using this mesh product and never had any problems. Unfortunately, there are thousands of women who were treated with this dangerous mesh and are worse-off following the surgery than they were before. In many cases, patients suffer erosion of the vaginal tissue, bladder or bowel perforation, painful infections, recurrence of the pelvic organ prolapse requiring additional surgery, painful sexual intercourse, urinary incontinence, and need for more surgery. This obviously causes severe frustration and depression in these patients who underwent these procedures for an improved quality of life, not to be in worse shape, requiring further surgeries. Even though there are still some doctors who insist that vaginal mesh is safe and the risks and complications are relatively low, the women whose lives have been ruined by this dangerous medical product strongly disagree. Most of these women say that if they could do it over again, they would rather live with the original problems or seeks a safer alternative treatment. One woman involved in the vaginal mesh litigation explained, “If you put it on a scale of 1-10, my original problem was a 10. Now it’s over a 100. My quality of life will never be the same…”
On July 13, 2011, the FDA ordered new warnings for transvaginal mesh devices. The mesh tends to erode and break over time, resulting in recurrent infections, severe pelvic pain, painful intercourse, urinary and bowel dysfunction, and even organ perforation. Some patient’s partners have been injured from the eroded mesh during sexual intercourse.
As of April, more than 650 women across the country have filed personal injury and product liability lawsuits. The number of plaintiffs has grown so much that lawsuits against the three largest manufacturers were consolidated in February to a multidistrict litigation (MDL). There are more than 1,400 federal and 500 state lawsuits filed against transvaginal mesh manufacturers, and the number continues to grow. Federal mesh cases have been consolidated into four MDL based on the manufacturer they’re filed against.
In most cases, injuries caused by vaginal mesh fall under product liability, and the maker of the defective mesh is held responsible. Treatment for defective vaginal mesh complications can include multiple surgeries. Even after these surgeries, there may be permanent injury. Compensation can pay for medical care, time off work during recovery, damage to quality of life and more.
Johnson & Johnson’s Ethicon division announced this week that they will stop selling its controversial transvaginal mesh as it faces hundreds of lawsuits from patients who allege implants used during pelvic organ prolapse and stress urinary incontinence repairs caused post-op complications, infections and even death.
The mesh products being discontinued are the Gynecare TVT Secur, Gynecare Prosima Pelvic Floor Repair System,Gynecare Prolift Pelvic Floor Repair System, Gynecare Prolift MTM Pelvic Floor Repair System. Sales will cease at the end of 120 days. This time period would allow hospitals and surgeons to find suitable alternatives.
Ethicon denies that the decision was made in response to the product liability lawsuits that have been filed in connection with the mesh, but that the “negative overall publicity about vaginal mesh devices” motivated the discontinuation.
Ethicon is asking to cease sales of the above mentioned four products, however, also requested that they be permitted to continue selling its Gynecare Gynemesh (with a change to the labeling that restricts its use to abdominal sacrocolopopexy procedure for the treatment of pelvic organ prolapse).
The decision by Johnson & Johnson could possibly be due to the company’s desire to prevent more lawsuits against devices. The jury will see that the fact that Johnson & Johnson are pulling this product shows that even they do not believe this product is safe. But the best part about this discontinuation of their mesh products is that it will be off the market and unable to hurt more women and ruin more lives.