If you have or had stress urinary incontinence or pelvic organ prolapse (POP), then you may have been treated using transvaginal mesh (TVM) or your doctor may recommend that TVM be used as part of a surgical correction of your problem. Unfortunately, it has become clear that TVM presents some serious medical complications. If you are suffering from these complications, you may be able to take legal action. If you have not yet had your procedure, you should know what types of complications can arise from TVM so you can make a fully informed choice about whether to take the risk of having the mesh implanted.
Our Boston personal injury attorneys have been closely following the FDA updates as well as monitoring other research, news and information about TVM complications. We want every patient to understand the potential medical complications that so often go along with the use of TVM.
Types of TVM Medical Complications
TVM is implanted to support the organs of the pelvis that are prolapsing. Prolapsing means that the organs are no longer sufficiently supported and they are intruding on the walls of the vagina. TVM is also implanted to provide support and strength for vaginal muscles in women that are experiencing stress urinary incontinence. The complications, however, can begin shortly after the mesh has been implanted. The medical complications associated with TVM can include:
- Chronic pain
- Mesh erosion or a breakdown of the vaginal mesh
- Serious infection
- Urinary problems
- A recurrence of prolapse
- Bowel, bladder and blood vessel perforation
- Pain during sexual intercourse
- A narrowing of the vaginal wall
In many cases, a revision surgery is necessary in order to try to correct the TVM medical complications or to correct the problem of recurrence of prolapse. Some women even have to undergo multiple surgeries and even with these repeated surgeries may not be able to eliminate the painful side effects they are experiencing.
Does TVM Always Cause Medical Complications?
TVM does not necessarily cause complications or problems in every single case when the mesh is used. However, the FDA has become increasingly concerned about how common the complications are. In 2008, the FDA issued a warning reporting that it had been notified of approximately 1,000 adverse reactions to the mesh. Based on the reports of the problems, the FDA indicated that while there were potential complications, those complications were rare.
More complaints began to flood the FDA, however, with 2,874 additional reports of problems coming in between January 1, 2008 and 2010. The additional complaints as well as a review of scientific literature on TVM dating back to 1996 prompted an FDA investigation and a revision to its warning in 2011. In the updated TVM warning, the FDA indicated that complications were not rare. Further, the FDA indicated that the risks presented by TVM were not present in more traditional treatment methods and that it was not clear that there was any overall benefit to using the mesh instead of more traditional treatment.
What Should Women Do?
Based on the new information by the FDA as well as other relevant medical studies, women who have experienced transvaginal mesh medical problems or complications should consider filing a lawsuit against the manufacturer of the TVM used in their procedure. Those women who have not yet had transvaginal mesh procedures should consider carefully whether to allow this potentially dangerous product to be used in their bodies.
If you or a loved one has experienced TVM complications, contact the Law Offices of Jeffrey S. Glassman, LLC for a free consultation. Call 1-877-617-5333.