Thousands of women are filing transvaginal mesh lawsuits because of the harm, the pain, and the suffering that they experienced after surgeons used this product to treat a gynecological or urological condition. Several different companies make these products and many have been recalled over safety concerns ranging from excessive pain and bleeding to severe organ damage.
Transvaginal mesh is a product that did not have to be seriously scrutinized in order to be approved for use by the U.S. Food and Drug Administration (FDA). It has, however, been recognized by the agency as risky and comes with serious warnings about the possibility of complications. That warning came too late for thousands of women who are now filing lawsuits and hoping for the compensation that they deserve after suffering so much.
Transvaginal Mesh: What Is It and How Is It Used?
Transvaginal mesh is similar to any type of surgical mesh. Surgical mesh is a tool used by surgeons and which may be made of either synthetic materials or animal tissues woven into a tight knit. Surgeons use this mesh to make repairs and to support organs. Transvaginal mesh is really no different, but it has specific applications in women.
It is used to treat pelvic organ prolapse to support the uterus after surrounding muscles and tissues have become too weak to hold it in place. It is also used to treat stress urinary incontinence, a condition in which small physical stresses cause bladder leakage. The mesh is used to support a weakened bladder, bladder neck, or urethra.
This specific mesh product came about years ago when surgeons were trimming surgical mesh to fit into the pelvic cavity for supporting organs like the uterus or bladder in women with certain conditions. Medical device companies, like those already making surgical mesh, realized that they could sell kits with pre-trimmed mesh and other tools that surgeons could use for the uterus and bladder. This was sold as transvaginal mesh, and unlike surgical procedures with mesh, this specially-sized mesh could be inserted through the vagina.
Transvaginal mesh was supposed to be a product that allowed women to be treated without needing invasive surgery. Instead of using an incision in the abdomen, the less invasive procedure could be used and should have led to quicker recovery times and fewer risks of complications. Unfortunately it didn’t work out that way and now the makers of transvaginal mesh are facing thousands of lawsuits.
Instead of being safer, it turned out that transvaginal mesh could cause a number of complications, many very serious. The FDA has an adverse event reporting system and between 2005 and 2010 it received almost 4,000 reports of complications arising from transvaginal mesh.
These include reports of infection, excessive bleeding, pain, worsening of the original condition, scar tissue, incontinence, and organ damage. In many of these situations women had to have additional surgeries to correct the damage. The complications are so common and severe that a trial that was supposed to compare transvaginal mesh to traditional surgery was stopped early to protect the patients.
Erosion, Perforation, and Permanent Damage
Many of the lawsuits against the makers of transvaginal mesh have included cases in which a woman experienced the most severe and lasting damage from the mesh. It begins with erosion, in which the mesh recedes into the surrounding tissue. This can be really painful, can lead to infections, inflammation, and bleeding, and it requires surgery.
If erosion is not caught in time the mesh can actually move through tissues in the pelvic region and damage other organs. Some women experienced perforation of the intestines because of this and in addition to pain, bleeding, and additional surgeries, perforation can lead to permanent damage.
To remove eroded mesh is complicated and often requires multiple surgeries. Mesh is designed to stay in the body indefinitely, so tissue and blood vessels grow around it over time. This means that to remove it surgeons must be very careful and take it out bit by bit. A woman going through this process may spend years in pain, suffering with the complications and trying to recover from surgeries.
FDA Approval and Non-Surgical Uses
Lawsuits over transvaginal mesh accuse manufacturers of wrongdoing, including not testing their products fully. These mesh products were mostly approved through the FDA’s 510(k) process, which is used for devices that are similar to others on the market. Because transvaginal mesh was like surgical mesh, it got approved this way and did not have to go through rigorous testing. If it had, some of the serious complications may have prevented it from ever getting approved.
Another possible issue with transvaginal mesh is that because it is designed to be inserted vaginally and not surgically, the procedure was often performed by a gynecologist in a doctor’s office and not by a surgeon in a sterilized operating room. Some plaintiffs in cases believe the product makers should have included warnings that infections were more likely if used in a doctor’s office.
Multidistrict Litigation and Individual Cases
Nearly 70,000 women have sued over transvaginal mesh and many were consolidated into several multidistrict litigations. These huge consolidated cases include several medical device companies: C.R. Bard, Boston Scientific, Coloplast, Cook Medical, American Medical Systems, and Ethicon, a division of Johnson & Johnson.
Since all of these cases were filed, several women received settlement offers. Endo Health Solutions, the parent company for American Medical Systems has so far paid out twice, first for $54 million and again in 2014 for $830 million to settle several cases. One individual was awarded more than $11 million by Johnson & Johnson, after she had 18 surgeries to correct damage caused by the company’s transvaginal mesh. These are just a couple of examples of the money that device manufacturers have been paying out to compensate the women who have suffered.
The accusations that plaintiffs made in these cases included that the companies making and selling transvaginal mesh failed to test their products adequately, misled the FDA and the public about how safe the products were, did not establish safe guidelines for how to use the mesh, and did not warn patients or doctors of all the risks. If you have been harmed because of transvaginal mesh, there may still be time to make your case.