WHAT IS TRANSVAGINAL MESH?
Introduced in the 1990s, transvaginal mesh was intended to treat Stress Urinary Incontinence (SUI) and Pelvic Organ Prolapse (POP) conditions that affect some women after childbirth, menopause or a hysterectomy.
To fix this condition, many women have undergone transvaginal mesh surgery wherein a hammock-like piece of synthetic mesh is implanted transvaginally, (or through the vagina), to support the prolapsed pelvic organs.
TRANSVAGINAL MESH COMPLICATIONS
According to the FDA, the most common complication associated with transvaginal mesh is mesh erosion in which the rough edges of the synthetic mesh cut through the vaginal lining and surrounding organs. In addition to organ perforation, transvaginal mesh erosion has been linked to infection, bleeding, pelvic pain, pain during intercourse, urinary complications, recurrent prolapses, neuromuscular problems, vaginal scarring and resultant emotional problems. Furthermore, men can also suffer pain and irritation to the penis through exposure to eroded mesh during intercourse.
Mesh erosion has required many women to undergo multiple surgeries to repair or remove the transvaginal mesh. These procedures are often painful, dangerous and costly because tissues grow in and around the mesh. Multiple surgeries are often required before all the mesh pieces can be removed. The recovery period is lengthy and the risk of further damage or infection is high.
In addition to mesh erosion, the FDA also warned the mesh often contracts, or shrinks, once implanted inside a woman’s body. Mesh contraction causes vaginal shortening, tightening and pain. Contraction can also inhibit a woman’s ability to engage in intercourse.
FDA WARNING ABOUT SERIOUS COMPLICATIONS ASSOCIATED WITH TRANSVAGINAL MESH
In 2011, the FDA issued a troubling updated Public Health Notification in which it stated:
On Oct. 20, 2008, the FDA issued a Public Health Notification and Additional Patient Information on serious complications associated with surgical mesh placed through the vagina (transvaginal placement) to treat POP and SUI.
Based on an updated analysis of adverse events reported to the FDA and complications described in the scientific literature, the FDA identified surgical mesh for transvaginal repair of POP as an area of continuing serious concern.
The FDA is issuing this update to inform you that serious complications associated with surgical mesh for transvaginal repair of POP are not rare. This is a change from what the FDA previously reported on Oct. 20, 2008. Furthermore, it is not clear that transvaginal POP repair with mesh is more effective than traditional non-mesh repair in all patients with POP and it may expose patients to greater risk.
TRANSVAGINAL MESH LAWSUITS
Transvaginal mesh recalls date back to the 1990s, however, this dangerous product continues to remain on the market. Thousands of women have suffered a diminished quality of life—or even death in some rare cases—as a result of transvaginal mesh complications.
As a victim of transvaginal mesh complications, you may be eligible to recover damages for:
- Additional surgery and multiple surgical revisions
- Emotional distress
- Loss of ability to have sexual relations
- Loss of quality of life
- Lost wages
- Out-of-pocket medical, surgical and hospital expenses
- Pain and Suffering
Family members may also be eligible to recover damages in their own right.