What is Vaginal Mesh?
Transvaginal mesh, also known as pelvic mesh or bladder slings, is a surgically implanted mesh device used to treat pelvic organ prolapse (POP) and stress urinary incontinence (SUI) in women. POP occurs when the muscles holding pelvic organs in place are weakened, resulting in the bladder dropping (or prolapsing) and pressing against the walls of the vagina. SUI, on the other hand, occurs when an activity such as coughing or sneezes causes urine to leak out of the urethra. Vaginal mesh is used to repair these issues by providing extra support to the weakened or damaged tissue. It is made from either porous synthetic material or biologic material.
Surgical mesh has been used since the 1950s, but during the 1990s, surgical mesh began to be used to treat the abdominal repair of SUI. In 2002, the product was approved and used for transvaginal repair of POP to lower the POP relapse rate following traditional surgery. However, the product soon began to cause issues and women suffered debilitating side effects. According to a 2017 study, researchers suggest that up to 40% of women suffer injuries as a result of medical instruments used to implant transvaginal mesh.
The synthetic vaginal mesh has edges that, in some cases, pierce the surrounding tissue and are capable of puncturing the bladder, uterus, or bowel. The sling can also migrate and in the process, do irreparable damage as they move around. Women can also suffer 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. Of those manufacturers, C.R. Bard, American Medical Systems, Boston Scientific, Ethicon (a subsidiary of Johnson & Johnson), Coloplast, and Cook Medical are the most prominent. A vaginal mesh lawsuit was filed against the manufacturers of vaginal mesh products.
What are Common Vaginal Mesh Injuries?
The injuries that women are alleged to have suffered 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 can cut through the skin after implantation, causing infection and cutting into nearby structures sometimes puncturing the bladder, bowel, and uterus.
Complications from these infections can include incontinence, extreme pain during intercourse, UTI, back pain, inability to walk, etc. Some of these infections can spread through the whole body and lead to death.
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. Yet, sometimes these injuries can take years to develop after the initial surgery. Tens of thousands of women have filed lawsuits alleging they were injured by pelvic mesh products.
Unfortunately, about 30 percent of women who underwent mesh surgery for POP will need another related surgery.
Due to the high complication risk, the FDA has re-classified vaginal mesh used to treat POP as a high-risk device. The classification does not, however, apply to the vaginal mesh used to repair SUI. Regardless, many surgeons have stopped using vaginal mesh altogether because of the risks involved.
There are other safer alternatives to synthetic mesh, such as biological mesh, that should be considered before the decision is made to use synthetic materials.
What Can Be Done To Avoid Vaginal Mesh Injury?
Women with these products in their bodies should be aware of symptoms indicating movement of the mesh so that they can know when to seek medical care. If you suffer any complications or symptoms that you think could be related to the placement of a mesh implant, alert your physician immediately. Following the advice of a qualified physician is most important.
The failed mesh implants commonly require removal surgery. Unfortunately, this is much easier said than done.
Can the Pelvic 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 with the surrounding tissue, causing life-long problems and severe pain.
Who Manufactured Vaginal Mesh?
- Johnson & Johnson
- American Medical Systems (now a unit of Endo Pharmaceuticals)
- Boston Scientific
- C.R. Bard
The four listed manufacturers are all considered to be the top manufacturers of transvaginal mesh products in the United States. Together, they faced thousands of lawsuits.
Who is Monitoring the Safety of Vaginal Mesh Kits?
More than ten years ago, vaginal mesh kits were introduced to the market in an attempt to obtain the benefits of a more durable repair as well as to simplify and standardize the technique of mesh placement vaginally.
It now appears that a substantial number of women who underwent surgical procedures using mesh to repair pelvic organ prolapse or stress urinary incontinence are left with a whole new set of complications that may require further surgery. These women can’t help but question the system and the manufacturers that should have protected them from further injury.
Vaginal Mesh Lawsuit
More than 100,000 vaginal mesh lawsuit(s) have been filed over the years. Many have resulted in settlements, with some resulting in multimillion-dollar settlements, however, some vaginal mesh lawsuit(s) are still on-going. At this time, TorHoerman Law is no longer accepting vaginal mesh cases.
If you have any questions regarding the vaginal mesh lawsuit, please contact us.