Surgical mesh is not a new type of medical device. It has been used for decades, most commonly to treat and repair hernias. More recently surgeons and gynecologists began using that same mesh in transvaginal procedures to treat women with organ prolapse or a certain type of urinary incontinence. Initially thought to be safe because it was less invasive to insert the mesh through the vagina than through an abdominal incision, the transvaginal mesh procedure is now known to be high-risk.
There are several possible complications that can arise after having this mesh inserted and there have been thousands of complaints and reports of adverse events to the U.S. Food and Drug Administration (FDA). Erosion and perforation of organs are just two of the potential complications that have affected women. Lawsuits have been filed against the companies who make the mesh for failing to test the product adequately and even possibly for hiding the known risks from doctors and patients.
What is Transvaginal Mesh?
Surgical mesh is a tightly woven material, which may be made from synthetic materials or animal tissues. It has traditionally been used to support organs or adding extra support to tissues that are damaged. For example, a hernia occurs when the intestines push through the muscles of the abdominal wall in a weak spot. Mesh can be applied to that weak spot to support the intestines.
Transvaginal mesh is the same kind of material, but is used to treat gynecological conditions in women. Instead of being applied through a surgical incision, the mesh is inserted through the vagina and set in position. The procedure can be done by a surgeon, but it is also often done by gynecologists in an office setting.
What Does Transvaginal Mesh Treat?
Surgical mesh was not initially designed to be inserted vaginally, but doctors and surgeons started using the mesh in this way because it seemed like a safer, less invasive way to treat certain gynecological conditions in women. Originally the mesh would be trimmed to the right size and shape, but eventually the manufacturers of the mesh started designing materials just for these procedures. They also made kits that included the mesh as well as specialized tools.
The two conditions treated with transvaginal mesh are pelvic organ prolapse (POP) and stress urinary incontinence (SUI). POP occurs when the muscles and other tissues that support pelvic organs, like the uterus or bladder, weaken. Those organs may then prolapse, or slip out of place. The mesh is used to support the weakened tissues so they can better hold organ sin place. SUI is urine leakage that occurs during movement, coughing, or other physical stresses. It occurs because of a weakness in the urethra or neck of the bladder, and mesh can be used to support these weakened areas.
Traditional procedures for treating POP and SUI include surgery and an abdominal incision. The mesh is inserted through the incision and implanted to provide the right support. It was only recently that doctors began to insert the mesh through the vagina instead of surgically through the abdomen.
Approval of Transvaginal Mesh
Medical devices like mesh are not required to go through the same rigorous testing or approval process that drugs are. They can be cleared through the FDA’s 510(k) process, which only requires that the manufacturer submit information about the device and show that it is similar enough to another device on the market. Since transvaginal mesh is essentially like any other surgical mesh, it has been cleared through this process and has never been tested thoroughly in clinical trials.
The FDA has issued multiple warnings about transvaginal mesh beginning in 2008. This first announcement warned of the serious complications that could arise in patients who had mesh inserted to treat pelvic organ prolapse or stress urinary incontinence. Later that same year the FDA updated the announcement to make it clear that the complications were not rare. The announcement also stated that the procedure may not be any more effective in treating these conditions than traditional surgical methods.
In 2016 the FDA issued another safety statement regarding transvaginal mesh. The update included a reclassification of the mesh from class II to class III. While previously considered a medium-risk medical device, the new classification makes it a high-risk device. The same announcement included a statement that manufacturers of the mesh now need to provide the FDA with a premarket approval application to show that the device is safe and effective.
Several complications of transvaginal mesh procedures have been reported through the FDA’s adverse events reporting system. Between 2005 and 2010 the agency received nearly 4,000 reports. The complications have included erosion, infection, urinary problems, bleeding, the formation of scar tissue, incontinence, pain, and a recurrence or worsening of organ prolapse, just to name the most common complaints. Many of these have required that women have additional surgeries to correct.
Complications are common enough and serious enough that a trial intended to test the safety and effectiveness of the procedure was stopped early. The trial was supposed to compare the procedure to traditional surgery, but several of the participants experienced serious complications, so the trial had to be stopped in the interest of safety.
Erosion and Perforation
Of all the reported complications, two have proved to be very serious: erosion and organ perforation. Erosion is a word used to describe the passing of a surgical material through tissues in the body. With transvaginal mesh this may occur as the mesh erodes into, or passes into, the wall of the vagina. The result of this is often pain, infection, bleeding, and ultimately nerve damage. Sometimes the rough edges of the mesh go all the way through the wall and out the other side, causing even more complications. Surgery is required to remove the mesh.
Organ perforation can occur when the mesh erodes all the way through the vaginal wall or other tissues and perforates or punctures other organs or tissues. The bladder or intestines, for instance, may become perforated by the sharp edges of the mesh. This causes pain, bleeding, and infections, and needs to be corrected surgically. Surgery may also be needed to correct damage done to other organs.
Some experts claim that erosion and perforation are the direct result of the fact that transvaginal mesh procedures are not always conducted in a sterile environment. Traditional surgery, performed by a surgeon, is done in a highly sterilized operating room. The transvaginal procedure is often conducted by a gynecologist in a doctor’s office. It may be that the erosion begins because of infection in the tissue surrounding the mesh.
Many women have suffered the serious complications of transvaginal mesh procedures and they are filing lawsuits against the companies that make the mesh and the kits. Thousands of lawsuits have been consolidated into several multidistrict litigations, or MDLs. Manufacturers implicated in these lawsuits include American Medical Systems, C. R. Bard, Boston Scientific, Cook Medical, Coloplast Corp., and Ethicon Inc., a division of Johnson & Johnson. Plaintiffs have argued that these companies did not test their products to find out what the risks were, that they knew about risks and hid them, and that they did not adequately warn doctors and patients about what could happen after the procedure.
One woman received $5.5 million dollars in jury-awarded compensation from C.R. Bard in 2012. American Medical Systems agreed to settle without going to trial and awarded $54 million to several complainants, followed by another $830 million to even more women involved in the MDL. Other individuals have received settlements and compensations through court verdicts and more settlements are likely to come in the future. If you have been affected by transvaginal mesh, you have the right to sue the manufacturer. Like thousands of other women, you too could get the compensation you need.