What is Transvaginal Mesh?
Surgical mesh is used in the repair of weakened or damaged tissue. Mesh can be synthetic or made from animal tissue. For example, transvaginal mesh has been used to treat conditions known as pelvic floor disorders, which include: Pelvic Organ Prolapse (POP): The muscles and ligaments supporting the pelvic organs weaken, which can cause the organs to fall out of place. Surgical mesh has been used to reinforce the vaginal wall.
Stress Urinary Incontinence (SUI): Physical movement puts pressure on the bladder, leading to unintentional loss of urine. Movement can include coughing, sneezing, running, or heavy lifting. Surgical mesh urethral slings can be implanted to support the bladder in a mesh sling procedure.
Complications from Transvaginal Placement of Mesh
According to the US Food and Drug Administration, transvaginal placement of mesh has been associated with numerous complications, including:
- Mesh erosion in the body
- Bowel or bladder perforation
- Infections
- Urinary problems and dysfunction
- Recurrence of SUI and POP
- Pain
- Pain during sex
- Vaginal scarring
Complications can require surgical intervention.
FDA Orders Mesh Manufacturers to Stop Selling Devices for Transvaginal Repair
In April 2019, the FDA ordered all manufacturers of surgical mesh intended for transvaginal repair of pelvic organ prolapse to stop sales and distribution of their products immediately. Following a review of their premarket approval process, the FDA determined manufacturers Boston Scientific and Coloplast “did not demonstrate reasonable assurance of safety and effectiveness for these devices, which is the premarket standard that applies to transvaginal mesh for pelvic mesh prolapse since the agency reclassified them into class III (high risk) in 2016. (FDA)
Manufacturers Have Settled Thousands of Legal Claims
Over the past decade, transvaginal mesh manufacturers have settled thousands of claims for roughly $8 billion. In addition, over 100,000 lawsuits have been filed, alleging the plaintiffs experienced health complications resulting from the manufacturer’s negligence, including misrepresenting the safety and efficacy of the mesh to the FDA, physicians, patients, and the public.
