There have been many lawsuits filed recently against American Medical Systems (AMS) after claims of serious side effects and injuries have come forward. According to these claims, the AMS vaginal mesh and bladder slings can possibly lead to serious, and life-threatening injuries.
A transvaginal mesh is a medical device made out of a surgical mesh and is designed to repair damaged or wekaned tissues that have been caused by Pelvic Organ Prolapse (POP) or Stress Urinary Incontinence (SUI). Around half of all women will experience a type of prolapse in their life, but only a handful will need to pursue a surgical treatment to fix the problem.
With more than 2,874 reports from 2008-2010 regarding vaginal mesh complications, the FDA has issued many Public Health Communication warnings to women and health care professionals stating the serious risks that can occur when using a vaginal mesh or bladder sling.
Some complications of AMS transvaginal mesh products include:
- Mesh erosion
- Mesh extrusion
- Urinary problems
- Pain during sex
- Vaginal bleeding
- Recurrence of POP
- Recurrence of SUI
The FDA had first looked at the transvaginal mesh implants in October 2008, and since then has been reviewing the device safety. The FDA says that these complications that follow a Pelvic Organ Prolapse repair surgery are not that rare and that evidence does not prove a mesh implant to be any more effective than not using a mesh. In fact, only may expose patients to a higher risk of injury.
American Medical Systems is affiliated with Endo Pharmaceuticals, Inc., Endo Health Solutions Inc., and Endo Pharmaceuticals Holding Inc. All of these companies have products, which are marketed and sold for use during pelvic repair. The following mesh products are included:
- Apogee Vaginal Vault Prolapse Repair System
- Monarc Subfascial Hammock
- MiniArc Single-Incision Sling
- Self-Fixating Sling System
- Bio-Arc System
- In-Fast Ultra
- Influence In-Fast
- Elevate Anterior and Apical Prolapse Repair Systems
These women who have been experiencing AMS transvaginal mesh complications will most likely need several additional surgical procedures to remove the mesh. Unfortunately, many will not fully gain complete relief from their symptoms.
Now, the FDA has considered reclassifying these transvaginal mesh devices from being a Class 2 (moderate risk) to a Class 3 (high risk) medical device. Giving transvaginal mesh products this high risk label would require these devices to have human clinical trials to try and gain the approval by the FDA for use during a Pelvic Organ Prolapse repair surgery.
If you are one of the many women who have been experiencing serious side effects from an American Medical System (AMS) transvaginal mesh implant product, get the legal help you deserve today.