F.D.A. Ends Sales of Transvaginal Mesh, Citing Complications

Transvaginal mesh has been regarded as a dangerous product for years. While usage of the product was in decline due to the well-publicized dangers that have been the subject of litigation throughout the years, the mesh was still being used in limited instances. In April 2019, the Food and Drug Administration halted all sales of transvaginal mesh (Pelvic mesh) by withdrawing its approval of the product. They gave the remaining manufacturers ten days to present a plan to the regulatory agency as to how they will withdraw the product from the marketplace.

FDA pulls plug on transvaginal mesh

At its height, transvaginal mesh was a widely used product. It had been used in surgeries to treat pelvic organ prolapse, a condition that can affect up to 50 percent of women at some point in their lives. In addition, the mesh was also used in the treatment of stress urinary incontinence. At one time, there were as many as 31 manufacturers of the product. At the time that the FDA announced its decision to remove the mesh from the market, the number of manufacturers had dwindled to two. The remaining two sellers of the product were Boston Scientific and Coloplast. Even for these sellers, the mesh represented a small fraction of their sales as women and doctors were simply afraid to use this product after years of strongly negative publicity.

Life altering Pelvic mesh complications

The FDA’s decision followed years of public lobbying of the agency for it to order a halt to transvaginal mesh sales. Advocacy groups for injured patients began as far back as 2011 to pressure the FDA to halt sales of these meshes. For the FDA, the product’s removal was a drawn-out process that unfolded over several years. The issues raised by patient advocates were magnified in the wake of a widely-publicized 60 Minutes report that put the spotlight on how these meshes were causing life-altering complications. This added to the pressure on the FDA to take some sort of action. Even after the FDA announced it ban, these patient groups criticized the agency for taking so long to do so. The product was used countless times even after the first reports of the side effects appeared in the media.

Market removal of mesh

Since transvaginal mesh is something that is implanted into the body, it is regarded as a medical device. The FDA is the regulator of all medical devices that are sold in the United States. In 2016, the FDA has reclassified transvaginal mesh to a Class III product. This designation applied to products that are considered high risk. At the time, the FDA had ordered the remaining sellers of the mesh to demonstrate to the regulator that the benefits of the product outweighed its risk. Usually, when manufacturers cannot make this showing, the FDA will order the product off of the market. Specifically, the FDA wanted the manufacturers to show that surgery with the use of the mesh was more effective than surgery that did not rely on the mesh. Here, Boston Scientific and Coloplast were given several years to make this showing, but they were unable to do so. As a result, the FDA reached its decision to remove the product from the marketplace.

Women may require further surgery

The FDA’s decision did not recommend that women who have had this mesh implanted now have it removed. Instead, the FDA advised women to continue monitoring their situations in consultation with their physicians. Those who have received the mesh should keep their annual checkups and do not necessarily require any type of special medical treatment. However, at the first sign of any side effects from the mesh, women should immediately see their physician to see what steps are necessary. In some cases, women may require further surgery to both remove the mesh and treat their pelvic organ prolapse.

Long history ended with  FDA order

The order ended a long history for transvaginal meshes. In general, meshes have been used in various surgeries where some internal organ, mostly in the midsection needs strengthening or repair. The two most common types of mesh are transvaginal mesh and hernia meshes. These products have been used millions of times since the 1950s.

Here, the mesh is used to strengthen the pelvis. It is called transvaginal mesh because it is inserted through the vagina until it reaches the pelvis. It is estimated that as many as one in every eight women have had surgery to treat these pelvic conditions. Some of these surgeries were done with the use of mesh. Before the side effects became known, transvaginal mesh was one of the highest selling medical devices in the United States.

Mesh side effects

However, meshes are not without their side effects. Like hernia meshes, transvaginal meshes are often made from synthetic products. Those meshes that are not degradable are actually not intended to degrade. Instead, they are supposed to remain in the body and continue to reinforce and strengthen the pelvis. In practice, that has not always been the case.

Mesh migration

One of the major side effects of transvaginal mesh is that the mesh does not always stay in the place where it is implanted. When the mesh migrates, not only does it no longer support the pelvis, but it also poses a danger to the organs that surround the mesh. The mesh can come into contact with these organs and cause them permanent damage. In some cases, the mesh can cause organ perforation. When this occurs, women can suffer intense and debilitating pain. While this condition is not usually fatal, there have been a handful of recorded deaths that have resulted from transvaginal mesh.

Mesh degrades

In other cases, the mesh degrades. This can cause other side effects. Beyond the obvious side complication of a recurrence of the pelvic organ prolapse, it can also have other negative impacts on the vagina. This can include pain during intercourse and incontinence in addition to nerve damage.

Mesh lawsuits

These side effects resulted in one of the largest series of medical device litigation in history. Thousands of lawsuits were filed against the manufacturers of these products. For the most part, the makers of these products chose to settle the lawsuits, and the total amount of settlements has run into the billions of dollars. The lawsuits that have resulted from transvaginal mesh are far from over. Manufacturers have set aside billions of dollars to cover possible future liabilities relating to this product.

Future legal liability

The future legal liability that these companies face is hard to quantify. Boston Scientific alone has been the defendant in 48,000 lawsuits brought by women who have suffered from complications from this product. Given that there were once 31 companies in this field, it is not inconceivable that the total amount of legal liability can reach into the tens of billions of dollars. As a result, most of the makers of the mesh gradually exited the field until there were only the last two remaining.  For example, Johnson & Johnson left the market in 2012 as a result of “changing market dynamics.” These dynamics likely included a large decline in the usage of the product as well as the fact that the company was subjecting itself to large legal liability every time one of its products were sold.

Mesh failure

Another issue that makes the future liability hard to gauge is that these meshes can fail at any time. A woman who had this surgery 15 years ago can start to experience side effects a long time after the procedure for the first time. In essence, those who have received this implant are walking around with the proverbial ticking time bomb inside their bodies. Thus, the makers of these meshes will be facing new suits for years to come given the large number of women who still have transvaginal mesh inside their bodies.

Mesh statute of limitations

If you have had transvaginal mesh implanted in a surgical procedure, it is critical that you contact an attorney at the first sign of trouble. It is important to know that you do have legal rights, even if you had the mesh implanted many years ago. The statute of limitations does not begin from the time that you had the surgery. Instead, it starts to run from the date that you knew or should have known that you have suffered complications. Certainly, you should be receiving regular checkups and should be monitoring the mesh for any possible side effects. If you start to experience pain, or any other type of complications, consult an attorney immediately to find out how you can receive financial compensation for the injuries that you have suffered.