Transvaginal mesh is a type of surgical mesh that is used to treat several different disorders. It is intended to strengthen and provide support for various urogynecologic procedures for female patients. However, there have been many concerns about its safety over the years as there have been complications from the use of the product. In addition, the FDA has increased its regulation of the product, going os far as to restrict its marketing and usage for various types of procedures. As a result of the complications that women have experienced when they have had transvaginal mesh inserted during procedures, there are a multitude of lawsuits against the manufacturers of this product. While some of these lawsuits have settled, others are at various points of the pre-trial process. If you believe that you or someone in your family has suffered harm from transvaginal mesh, please read the following regarding the nature of the problem and your legal remedies.
The Purposes of Transvaginal Mesh
There are several different medical issues that women suffer from that necessitated the use of transvaginal mesh. The first is pelvic organ prolapse. This is when the pelvis may not stay in place due to weakened muscles and the bladder drops. This places pressure on the vagina. In this instance, the transvaginal mesh is used to stabilize and support the pelvic organ. The second is stress urinary incontinence. This is when a mild activity can cause urine to leak from the vagina. This can be something such as sneezing or coughing. This is due to the weakening of the muscles that support the bladder, such as the pelvis. The transvaginal mesh is used to strengthen the surrounding tissue which has the effect of preventing the incontinence.
How Transvaginal Mesh is Made
Transvaginal mesh can be made out of any one of a number of different materials. The most common composition of the mesh is made from plastic. It can also made with a number of other different components including animal tissue. Synthetic transvaginal mesh products are intended to be a permanent implant into the body, while mesh made out of animal products is absorbed into the body. While the name implies that it is placed in the vagina, it is actually placed through the vagina into the abdomen. The benefit of this is that the procedure spares the patient from requiring an incision to the abdomen.
There are several different companies that make or have made transvaginal mesh. Johnson & Johnson, American Medical Systems, Boston Scientific and C.R. Bard are the major sellers of the product. All told, there are over 30 companies that manufacture transvaginal mesh.
Some Key Dates and Statistics
Transvaginal mesh was initially approved for usage by the FDA under its 510(k) process, which allows for approval of a product with significant testing. The FDA approved surgical mesh for transvaginal use in 2002. The lack of a need for testing was due to its classification as a moderate-risk product. This means that the product was not tested on humans before it was approved.
At its height, approximately 300,000 women per year were receiving transvaginal mesh implants during surgeries. The FDA believes that over two million women have received the implant over the lifetime of the product. In light of the complications that have been reported in connection with transvaginal mesh, this is a significant number.
Side Effects From Transvaginal Mesh
Women have reported suffering numerous side effects from transvaginal mesh implants. The most common side effects from this implant are infection and pain. In addition, women have reported experiencing urinary problems and vaginal scarring. Notwithstanding transvaginal mesh’s marketing to aid with surgery to relieve incontinence, the product has actually been reported to cause incontinence. In addition, many women have experienced the erosion of the transvaginal mesh. This is where the position of the mesh shifts such that edges of the mesh are protruding from the vagina. Many women have had to have an additional surgery to have the transvaginal mesh removed. This surgery also involves repairing the tissue that has been damaged by the mesh.
Once reports of complications began to increase, the FDA changed its classification of transvaginal mesh. In addition to classifying the mesh as a high-risk product, the FDA has also issued various safety notices relating to the transvaginal mesh. The FDA now recommends that patients ask their doctors why they are using transvaginal mesh and whether there are any other alternatives to its usage. Nevertheless, the product is still being used in the marketplace and pelvic implants are still a large potential market both in the United States and the rest of the world.
Transvaginal Mesh Litigation
There have been numerous lawsuits that have arisen from the use of this product. The lawsuits have typically alleged that the mesh has been designed defectively and that they are inherently dangerous for their intended purpose. The complaints have alleged that the manufacturers placed a defective product into the marketplace. The manufacturers are alleged to have possessed information about the product defects and the dangers associated with their use. Instead of warning the public about these dangers, the manufacturers did not reveal this adverse data and continued to market and sell the product as if it were entirely safe.
In addition, plaintiffs have alleged that manufacturers were negligent in designing and selling a product that caused injury to women. The plaintiffs claim that the manufacturers owed a duty to these women, and breached it by selling a defective product. Finally, the manufacturers have been accused of fraud through their alleged representations that the products were safe and that they were tested.
Many of these lawsuits have been settled by the manufacturers. Some of the cases that have gone to trial have resulted in large jury awards of damages against the manufacturers. Since transvaginal mesh was not a product that required FDA testing, manufacturers can face state law product liability claims. For example, in 2018, a jury in New Jersey awarded a plaintiff and her husband $68 million in damages for injuries that she sustained due to transvaginal mesh. Nearly half of this award was punitive damages assessed against C.R. Bard for their negligence and marketing of the product. There are many other lawsuits in this case that are in various stages of the trial process.
It is important to note that, not only can you bring legal action against the manufacturer of transvaginal mesh, but you can also file a complaint against the doctor who carried out the procedure. If you believe that you have been injured by transvaginal mesh, it is essential that you contact a lawyer as soon as possible, especially in light of the statute of limitations for product liability cases. Your lawyer can advise you of the latest legal developments in these cases as well as the merits of your potential claim for compensation.