Transvaginal Mesh Devices Can Cause Injury, Says FDA

August 31, 2011

Transvaginal mesh devices are usually implanted to strengthen a woman's vaginal tissue and support the weight of the surrounding organs after a woman experiences pelvic organ prolapse (POP). Recent reports from the Food and Drug Administration (FDA) indicate that these transvaginal mesh devices can cause injury in women who have had the potentially defective device implanted.

What Is Pelvic Organ Prolapse (POP)?

It is not uncommon following a pregnancy or other medical condition for a woman's vaginal tissue to weaken. When this happens, a woman may experience POP, which essentially causes internal organs such as the bladder, uterus and bowel to shift position. This shift often leads to pelvic discomfort and disrupts normal sexual, urinary and bowel function. Transvaginal mesh devices, or pelvic slings, are implanted to prevent this shift by strengthening the vaginal tissue wall.

Problems With Transvaginal Mesh Devices

After receiving numerous complaints from patients about the device, the FDA in 2008 sent a letter to doctors using transvaginal mesh patches in their patients and cautioned them about the problems associated with the implants.

A separate study by the New England Journal of Medicine found that there was an inherent risk in implanting the transvaginal mesh device, and while implantation may be more successful than other forms of surgery, the associated side effects were much more serious.

Common complaints from women experiencing problems with the device include:
- Skin breakage
- Bleeding
- Device protrusion
- Urinary incontinence
- Serious infections
- Mesh contraction that leads to vaginal shortening, tightening and pain
- Erosion of mesh through the vagina
- Return of pelvic organ prolapse (POP)

Since the FDA's original safety notice in 2008, the number of complaints has continued to rise, prompting the FDA to once again take a closer look. The agency is convening with medical experts and device manufacturers in September to determine whether transvaginal mesh devices should remain on the market.

A number of defective device lawsuits have already been filed against several manufacturers of transvaginal mesh devices. Manufacturers of the most commonly used transvaginal mesh devices and sling support systems include American Medical Systems, Boston Scientific Corp., C.R. Bard and Ethicon, a subsidiary of Johnson & Johnson.

If you have a transvaginal mesh device and are experiencing problems, please contact an experienced defective medical device attorney in your area. It is important that you not only receive compensation for your injuries, but that you also receive the medical attention you need to recover from your vaginal mesh complications.

Article provided by Trolman, Glaser & Lichtman, P.C.
New York Medical Malpractice Attorneys