Transvaginal mesh, or “TVM” as it is often called, was not originally developed to be used to treat medical conditions affecting the female reproductive system. Surgical mesh has been around for many years, and, as that name implies, it is a woven medical grade textile that is used to reinforce a part of the body, such an organ that has experienced erosion.
Vaginal mesh was adapted from the already existing forms of surgical mesh and was marketed as basically a cure-all for women’s health issues. If you were suffering from pelvic organ prolapse (POP) for example, a surgeon could implant the mesh in a simple outpatient procedure, and you would be back to normal. This would also allow you to fix issues like stress urinary insentience. As our Boston transvaginal mesh injury lawyers can explain, the medical device companies put a lot of money into marketing these products and much less money and care into development and safety testing. They were offering TVM products in various forms, including transvaginal tape (TVT), or even a mesh patch. There were some applications where the mesh was suspended in a sort of medical hammock. The reason these various companies could get the products on the market so quickly is because when dealing with medical devices, as opposed to drugs, if there is a similar device already on the market, the new device maker can apply for a fast track to approval that is often granted. This is basically a loophole in FDA regulations that medical device makers could take advantage of.
However, as discussed in a recent news article from the Guardian, these TVM devices would often be defective, and the companies failed to properly warn women on known dangers and risks. Not only were these transvaginal mesh devices not curing the medical conditions they were designed to treat, in many cases, women were left in far more pain than they were before having the implant.
There are risks known by the makers of TVM products that the mesh could erode, for example. This leaves nerves exposed and a mess of broken surgical mesh that it might not even be possible to remove even with multiple operations. Some other side effects left women with constant and debilitating pain in their legs to the point where they are now wheelchair bound. These were otherwise healthy woman who got the implant because they had a minor bladder control issue and were led to believe TVM was a quick fix.
There are other women who suffer chronic painful urinary tract infections and some who must wear a catheter always. The pain has been described as unbearable and that is the reason for pain and suffering damages in many products liability lawsuits. This is not okay, and if you are the victim of a TVM device, you should contact and experienced TVM injury lawyer who can tell you if you have a valid claim against the medical device manufacturer.
A drug manufacturer has a duty to warn of known dangers. For this reason, in addition to negligence and defective design claims, your attorney will also typically file a failure to warn of a known danger claim.
If you are the victim of Massachusetts product liability, call the Law Offices of Jeffrey S. Glassman for a free and confidential appointment — 1-888-367-2900.
Vaginal mesh left me in agony. When will women’s health be taken seriously?, April 27, 2017, The Guardian
More Blog Entries:
New Total Knee Replacement Technology Helps Surgeons and Patients Alike, Nov. 25, 2015, Boston Hip Replacement Lawyer Blog