Pelvic surgical mesh, also known as transvaginal mesh, had been used for many years to treat women with pelvic organ prolapse. However, there have been hundreds of thousands of reports of side effects suffered by women who had this mesh implanted. These complications ranged from mild to severe. As a result, there have been a large number of lawsuits filed against the makers of these products. Recently, the Food and Drug Administration (FDA) ordered the last remaining manufacturers of this product to halt sales of it in the U.S. market.
Pelvic organ prolapse is a condition that affects many women, and it is estimated that as many as one in eight woman have had surgery to treat the condition. The mesh is inserted through the vagina and is used to support the pelvis. The mesh can also treat stress urinary incontinence.
Like any mesh that is made of synthetic material, the pelvic surgical mesh caused some significant side effects in the women who had this mesh implanted. The major complications of this mesh are that it either degraded or shifted out of place. When the mesh migrated, it caused damage to the surrounding organs. In a worst case scenario, this can perforate the organs. This mesh has caused women intense and debilitating pain that has kept tens of thousands from living a normal life. There have even been several documented cases of fatalities from this mesh.
These complications led to tens of thousands of product liability lawsuits against the manufacturers of these products. At the height of its usage, there were as many as 31 different makers of the product. However, legal liability and the decline in sales caused many makers of the product to exit the market. Many companies have settled the numerous lawsuits that they have faced. Others who are facing these lawsuits have increased their reserves for future possible settlements. After years of declining sales there were only two product manufacturers in the market. Both Boston Scientific and Coloplast, the remaining makers, indicated that this product was a very small part of their sales.
After years of reports of widespread complications from the mesh, there was a sustained campaign of pressure on the FDA to reduce sales of these products. Patient groups argued that the risks of the product did not justify keeping it on the market. In 2016, the FDA reclassified the product, assigning it the highest risk rating. The regulator gave the two remaining manufacturers a period of time to demonstrate that the benefits of the product outweighed the risk. When the companies failed to make that showing within the allotted period of time, the FDA announced that it was halting sales of the product. The companies were to meet with the FDA to outline the steps that they will take to remove the products from circulation.