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American Medical Systems settle portion of vaginal mesh suits for $54.5M

Transvaginal mesh was introduced in the 1990’s to help fix pelvic organ prolapse (POP) and stress urinary incontinence (SUI). Pelvic organ prolapse occurs when a woman’s pelvic muscles weaken and the pelvic organs drop into the vagina. These organs include the bladder, rectum and uterus. Stress urinary incontinence occurs from everyday activities that put pressure on the bladder. Both of these circumstances affect older women who may have received a hysterectomy, gone through menopause, or after childbirth.

The transvaginal mesh is surgically implanted through the vagina to help support the organs. However, as with many technological advances, this breakthrough also came with its share of disadvantages. The transvaginal mesh is associated with many complications. The most common are organ perforation and erosion. Transvaginal mesh erosion, also called mesh extrusion, occurs when the rough edges of the synthetic mesh cut through the vaginal lining and nearby organs. This can cause organ perforation, infection, bleeding, pain during intercourse and urinary problems. The Food and Drug Administration (FDA) noted that there are reports of recurrent prolapses, neuromuscular problems, vaginal scarring and emotional problems as a result of the mesh. Other complications include constipation and urinary incontinence (UI). UI is the involuntary loss of urine usually during pregnancy, after childbirth and menopause.

There have been many issues and complications associated with the FDA concerning the transvaginal mesh. A similar mesh has been used successfully for many years to remove hernias. However, the mesh was never tested by the FDA for use in vaginal repairs. The FDA’s fast-track approval system, called the 510(k), doesn’t require testing prior for a product’s release into the market as long as the product is similar to an already-approved product. In this case, the successful removal of hernias was the similar procedure and thus the mesh was approved.

In addition, after the FDA assessed the mesh further, conclusions were that the mesh does not fix the symptoms of pelvic prolapse or improve the patient’s quality of life more effectively than non-mesh repairs. The FDA also concluded that using the mesh causes more risks than a non-mesh repair would. There is no evidence that mesh used for repairs on the top or back wall of the vagina provide any added benefits compared to traditional surgeries without the mesh. The FDA also found that the mesh can shrink or contract once inside the patient causing pain and tightening. This erosion and contraction can lead to pain during intercourse. It can also cause irritation of the penis when exposed to the mesh. The drugwatch has more information concerning this issue.

American Medical System Inc., unit of Endo Health Solutions agreed to pay $54.5M to settle lawsuits of women who were in pain and left with incontinence after having transvaginal mesh surgically implanted. Officials of the company said in a securities filing that the medical device maker is paying to resolve an unidentified number of suits over the company’s vaginal-mesh devices. These devices include the Perigee, Apogee and Elevate implants.

There are 5,000 vaginal mesh suits that do not affect the settlement of the American Medical System. All 5,000 suits are being consolidated for pre-trial proceeding before a federal judge in West Virginia. The first case is set for December 2013.

If you or a loved one had transvaginal mesh implanted and has experienced complications or pain, please consult your doctor. In addition please call us for a free consultation. It is your right to learn the best treatment possible and your legal options concerning this issue.


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