Vaginal Mesh Recall
In 2011, the U.S. Food and Drug Administration (FDA) did a rare reversal of its medical opinion and declared that vaginal mesh, also known as transvaginal mesh or surgical mesh, is associated with serious complications.
For years, surgeons have been using vaginal mesh to fix pelvic organ prolapse (POP) and stress urinary incontinence (SUI) resulting from childbirth, a hysterectomy or menopause. Mesh was used to elevate the prolapsed organs. In 2008, the FDA looked into more than 1,000 mesh injury reports and downplayed the problems, calling them rare. Three years later, the FDA looked at thousands more injury reports and found a preponderance of problems.
While the FDA's declaration did not prompt a recall on the devices, medical professional and patients worldwide went on alert. Since the FDA originally said that problems with the devices are "rare," such a dramatic change in position prompted injured patients nationwide to seek justice in the court system.
Vaginal Mesh Warning
In its research, the FDA found that vaginal mesh used in organ prolapse and urinary incontinence surgeries is linked to painful and possibly disfiguring injuries, including:
- Mesh erosion – Also known as vaginal mesh protrusion or extrusion, this is considered the "most common and consistently reported mesh-related complication" resulting from transvaginal insertion of mesh, according to the FDA. This occurs when the flexible plastic material used to make the mesh disintegrates into the surrounding tissue. It can cause severe pain. "Mesh erosion can require multiple surgeries to repair and can be debilitating for some women. In some cases, even multiple surgeries will not resolve the complication," the FDA said.
- Vaginal mesh hardening – Once surgically inserted, mesh is known to harden, contract or shrink up to 85 percent and cause immense pain. The resulting problems include shortening or shrinkage of the vaginal cavity, pain and difficulty in sexual intercourse.
- Urinary problems – One of the most common resulting problems from vaginal mesh is urinary tract infections and ongoing urinary incontinence. The FDA said that studies show that mesh does not fix incontinence problems and in some cases may hasten additional problems.
- Pelvic or vaginal pain – For some women, the pain comes from the mesh hardening, for others it's from mesh erosion. And others still have pain from faulty mesh placement. There are many reasons for ongoing pelvic pain following mesh surgery.
- Internal organ injuries – Eroding or contracting mesh has been shown to puncture or perforate other nearby organs including the bowel, bladder and vagina. The injuries from such damage can take months to heal.
- Painful sexual intercourse – Eroding or hardening mesh has also been identified as the cause of pain and difficulty during sexual intercourse. The FDA noted that in a few cases women are simply unable to engage in sexual intercourse. Also, men may experience discomfort to the penis due to the breakdown vaginal mesh.
Transvaginal Mesh Recall Lawsuit
Patients who have undergone mesh surgery or painful revision surgeries are urged to take their medical wellness into their own hands and call our expert attorneys for a free case evaluation and consultation. Our legal experts will review your case and make recommendations regarding your legal right to compensation.