In July 2011, the public was given a vaginal mesh FDA warning—that is, the U.S. Food and Drug Administration (FDA) issued an “Update on Serious Complications Associated with Transvaginal Placement of Surgical Mesh.” The document, among other things, describes the side effects that have been reported in connection with implanting surgical mesh through the vagina in an attempt to correct one or both of the following conditions:
- Pelvic Organ Prolapse (POP)—a condition in which a woman’s reproductive or pelvic organs fall into or through her vaginal opening
- Stress Urinary Incontinence (SUI)–a condition marked by the involuntary leakage of urine from a woman’s urethra during moments of physical stress.
Erosion Is the Most Common Complication
The most consistently reported of all vaginal mesh complications and side effects, according to the FDA, has been erosion: The mesh (or sling) wears through the vaginal mucosa, exposing its rough and uncomfortable surface to the patient and her partner. It can take multiple surgeries to repair such erosion, according to the FDA.
Other vaginal mesh complications that patients have reported include:
- Urinary problems
- Blood vessel, bladder, or bowel perforation
- Vaginal tightening
- Dyspareunia (pain during sex) caused by vaginal scarring and vaginal mesh erosion
Patients have also reported complaints of mesh contraction (shrinkage), which often causes vaginal shortening, vaginal tightening and vaginal pain.
The vaginal mesh complaints and vaginal mesh complications and side effects experienced by thousands of women have been well documented by the media. Local and national news outlets have run stories chronicling women’s complaints of the extraordinary pain and suffering many vaginal mesh victims are experiencing.
Recent Warnings Do Not Single Out Any Brand
Several companies currently manufacture mesh products, including: Ethicon, a division of Johnson & Johnson; C.R. Bard; Boston Scientific; and American Medical Systems. In its July 2011 warning, the FDA specified that “the complications associated with the use of surgical mesh for POP repair have not been linked to a single brand of mesh.”