In the wake of mounting concern about transvaginal mesh and its related injuries, manufacturers have begun to reluctantly make TVM settlements to resolve the thousands of lawsuits filed against them. One such company is Boston Scientific, which has agreed to pay a huge sum to handle claims made against it.
Have you had serious complications after receiving Pelvic Mesh? Act Now. You may be entitled to financial compensation.
Boston Scientific To Pay $119 Million in Transvaginal Mesh Lawsuits
Boston Scientific agreed to settle nearly 3,000 transvaginal mesh cases on Tuesday, April 28, 2015. The pharmaceutical giant says it will pay nearly $119 million, increasing its product liability reserve for further litigation in the process. This step forward comes after years of transvaginal mesh lawsuits encompassing several major manufacturers and different TVM products.
Overall, Boston Scientific faces more than 24,000 total claims in both federal and state courts, and the number shows no signs of slowing down. While this is a huge step forward for transvaginal mesh litigation, the company continues to shirk any admission of wrongdoing in manufacturing and marketing its transvaginal mesh product. It has already lost two federal trials, one in Miami and one in West Virginia.
Transvaginal Mesh: Is It Even More Dangerous Than Organ Prolapse?
TVM was designed to treat organ prolapse, a condition that occurs as a woman ages or after giving birth. Organs begin to sink into the vagina, causing a variety of problems, ranging from incontinence to pain during intercourse. The mesh acts as a reinforcer of sorts, holding the organs in place almost like a hammock and preventing them from dropping further and causing more health problems. TVM is also frequently used post-hysterectomy to treat vaginal vault prolapse, a condition in which the top of the vagina begins to collapse on itself without the support of the uterus. In this instance, the mesh can be implanted into the pelvis and secured to the upper portion of the vagina.
While doctors and drug makers initially believed this device to be safer and more effective than the traditional surgical treatment, the dangers associated with TVM have quickly been revealed. After insertion, the mesh frequently moves and interacts with surrounding tissue in a way that frequently creates similar problems to organ prolapse itself. The “clean-contaminated” nature of the vagina means the device is exposed to a wide spectrum of bacteria as it’s inserted, often creating a wound that facilitates mesh erosion through the vagina. Incontinence is a frequent side effect, while more serious ailments include vaginal scarring, vaginal shrinkage and serious pelvic pain.
Unfortunately, transvaginal mesh injuries can only be rectified in some instances. Removal can necessitate multiple surgeries, which are not always successful. Extracting mesh is nearly impossible to do in full, and puts surrounding tissue as risk of further injury. Many women are left with pain, during intercourse or otherwise, for the rest of their lives.
The Repercussions of an Approval Loophole
The device received FDA approval through a loophole called the 510(k) approval process, meaning it was similar enough to an existing device to pass premarket approval. The initial device however, a recalled brand of TVM made by a different manufacturer, caused similar issues. This correlation was unfortunately not considered during TVM’s subsequent approval and several drug makers pushed new models to the market.
Speak With a Professional
If you or someone you know has suffered an injury after the insertion of transvaginal mesh, you may be eligible to file a lawsuit. It’s a good idea to have your case reviewed by attorney, as he or she can help you make your claim and be more successful moving forward. With more companies like Boston Scientific agreeing to settlements, now is the time get the damages you deserve.