Transvaginal mesh (TVM) is used to help women suffering from a prolapsed uterus and/or stress urinary incontinence. These conditions often develop after a woman has given birth, but may also occur after menopause or after a hysterectomy, as well as after certain kinds of trauma. The material is the same that is used to correct hernias. An estimated 75,000 women in the US had surgery requiring vaginal mesh products. Unfortunately, the failure rate of these products is alarmingly high. As of July 2011, the FDA received 2,800 complaints about vaginal mesh products.
What are the problems associated with transvaginal mesh?
TVM is associated with a number of serious and even life-threatening complications, including:
- Perforation of the uterus, bladder, urethra, rectum or bowel
- Erosion of the mesh materials
- Severe pain
- Difficult and/or painful sexual intercourse
- Severe bleeding
- Permanent scarring
- Permanent incontinence
- Nerve damage
- Increase chance of infections and/or recurring urinary tract infections
When the mesh erodes, it requires a revision surgery to fix. For patients whose TVM was used for stress urinary incontinence, there is between 2% and 4% chance of erosion.
Who is responsible?
There are a number of companies which make TVM implants, and because these companies submitted their products through the FDA’s 510(k) Premarket Notification Process, the mesh was able to be sold without having to go through the standard testing process.
Each of the following companies markets TVM implants – and each is now involved in a multi-district litigation lawsuit:
- American Medical Systems
- Bard Medical
- Boston Scientific Group
- Coloplast Corp.
- Cook Medical Inc.
- C.R. Bard
- Ethicon Inc. (Johnson & Johnson)
If you or a loved one underwent surgery to implant a vaginal mesh product and suffered serious side effects or complications, please contact Plaxen & Adler, P.A.