US, British officials investigate vaginal mesh complications

Lawsuits have been arising in Massachusetts and throughout the rest of the country over faulty vaginal mesh devices. The surgical mesh implants have been used to repair pelvic organ prolapse or stress urinary incontinence in women, but can have very serious complications.

Over the past several months, health regulators in the United States and the United Kingdom have expressed concern over the risks associated with vaginal mesh products; however, the U.S. Food and Drug Administration has not yet banned the products.

Currently, the FDA is considering re-qualifying the devices as high-risk, and a Safety Communication has been sent to patients alerting them of the dangers. One of the most common risks is infection, which can be caused by the mesh product cutting into the vaginal walls, tissues and organs.

Similar action is being taken in the United Kingdom as it has been reported that Britain’s drug and medical device regulator is reviewing the claims of many patients who have had problems with vaginal mesh products. The review was announced in February, but no results have been announced as of yet.

One American woman said she began suffering from serious complications just months after having the vaginal mesh surgically implanted. In her lawsuit, the woman claims that the maker of the vaginal mesh product, American Medical Systems and its subsidiary Endo Pharmaceuticals, hid the dangers from her and her doctors.

There have been several thousand reports of injury, death and malfunction associated with mesh implants in the United States alone. Women who are suffering from complications or have had to undergo additional medical procedures because of faulty vaginal mesh products should know that they may be entitled to compensation.

Source: Drugwatch, “Transvaginal Mesh Injuries Ruin Lives FDA Slow To React,” Barb Stephens, April 11, 2012