Surgical mesh, which is used for transvaginal mesh surgery and bladder slings, is a medical device that is generally used to repair weakened or damaged tissue (specifically in pelvic organ prolapse (POP) or stress urinary incontinence (SUI)). It is made from either porous synthetic material or biologic material.
On July 13th, the FDA issued an Alert stating that serious complications associated with vaginal mesh/bladder slings for transvaginal POP repair are not rare. In fact, the FDA noted that they have received thousands of voluntary reports from patients, friends or doctors indicating complications occurring as a result of the vaginal mesh/bladder sling, with at least 10 of the reports resulting in death. Recent studies estimate that the actual rate of injury is likely to increase significantly, which should not be surprising considering that more than 100,000 of these types of procedures are performed annually. There could be tens of thousands of injuries and hundreds of deaths according to reports made to the FDA.
What is the bladder sling/vaginal mesh product used for?
The bladder sling/vaginal mesh product is implanted during surgery to repair POP and SUI. The synthetic mesh has edges that are in some cases piercing the surrounding tissue and puncturing the bladder, uterus, or bowel. The “patches” can also migrate doing irreparable damage as they move around. Women are also suffering horrible infections because of the mesh.
These types of mesh underwent virtually no safety review by the FDA or any other regulatory agency before being put on the market by manufacturers.
What are the injuries?
The injuries that women are suffering from this mesh implant are severe and debilitating and could have been avoided had people had the proper information.
The edges of the mesh/sling cut through the skin after implantation causing infection and cutting into nearby structures sometimes puncturing the bladder, bowel, and uterus.
Additionally, petroleum based synthetic material is particularly capable of causing infection because the material itself is a "breeding ground" for bacteria. Complications from these infections include incontinence, extreme pain during intercourse, UTI, back pain, inability to walk, etc. Some of these infections spread through the whole body and lead to death.
There are other safer alternatives to synthetic mesh (biological mesh for example) that should be considered before the decision is made to use synthetic materials. Sometimes these injuries can take years to develop after the initial surgery.
Can the bladder sling/mesh be removed?
Once the mesh is implanted it is very difficult to remove. Even after multiple surgeries doctors are sometimes unable to remove all of the mesh which by that point has become infused to the surrounding tissue, causing life-long problems.