Transvaginal mesh is a medical device that has caused countless harm to thousands of women. Now classified by the U.S. Food and Drug Administration (FDA) as a high-risk device, at one time this mesh was considered to be a routine treatment for common gynecological and urinary conditions. It didn’t take long for the problems to be recognized, but in the meantime, a lot of women were irreparably harmed.
This type of mesh has been found to cause serious side effects and damage including erosion into surrounding tissue and perforation of nearby organs, both of which cause even more side effects and damage. The number of lawsuits over these side effects has soared as women seek both justice from the device makers as well as compensation for their numerous medical bills as well as pain and suffering.
Transvaginal mesh by itself is not necessarily harmful. It is no different from general surgical mesh, which is a tightly-woven mesh used for a variety of reasons: to support organs, to hold in the intestines in the case of a hernia, or to provide support to damaged tissues. Although transvaginal mesh is the same material as regular surgical mesh, the way in which it has been used is different and has caused serious side effects.
In many types of surgery with mesh, the procedure is conducted in an operating room and the surgeon makes an incision to insert the mesh. Transvaginal mesh is inserted through the vagina, which was originally thought to be less risky and less invasive, but has since proven to be even more risky.
Transvaginal mesh is used to treat a couple of common conditions in women. Pelvic organ prolapse, or POP is the weakening of tissues supporting the uterus or bladder. Mesh is inserted to support these organs. Stress urinary incontinence, or SUI, occurs when the bladder or bladder neck weakens and small stresses lead to leakages. The mesh, again, is used to support the bladder or neck.
In the past, these conditions were treated like any other condition requiring mesh: through surgery. An incision was made in the abdomen and the mesh put in place. Manufacturers of surgical mesh realized there was a market for a product designed specifically for SUI and POP. They developed transvaginal mesh kits, which could be used by a gynecologist in an office setting instead of a surgeon in an operating room.
Complications and Side Effects
Transvaginal mesh has been labeled by the FDA as a high-risk medical device because it has been implicated in so many cases of terrible side effects. Exactly why it causes so many is not certain, but some experts suspect it is the way in which the procedures for POP and SUI are performed. It may be that gynecologists are not as well trained as surgeons for correctly inserting and positioning mesh and that doing the procedure in an office introduces more opportunities for infection.
The main complications of transvaginal mesh are erosion and perforation. In 2008 the FDA issued its first warning about the mesh products. It stated that there was a risk of complications and then later updated that warning to make it clear that the complications were more common than previously thought. The FDA also stated that transvaginal mesh procedures were not found to be more effective in treating SUI and POP than traditional surgery. It was an announcement in early 2016 that updated the classification of transvaginal mesh from medium-risk to high-risk.
The most common serious side effect of transvaginal mesh is erosion, the wearing of the mesh through soft tissues. Many individual reports have been made of erosion occurring, but studies have also found that the mesh can cause this complication far too often. One study found that the erosion rate in a group of nearly 4,000 women was ten percent.
When the mesh erodes through the vaginal tissue or other tissues, it causes serious side effects and symptoms. It can cause serious damage too. The only real solution is to use surgery to remove the mesh. This is complicated, though, and sometimes it isn’t even possible to remove the mesh without causing more damage. Some women with erosion have had to have multiple surgeries and still ended up with pieces of mesh in place permanently.
Erosion in itself is damaging and painful, but in some cases it can lead to the perforation of nearby organs. In other words, the mesh can move through tissue enough to actually puncture the bladder, large intestines, uterus, or urethra. If the mesh isn’t implanted correctly, the perforation may actually occur during the procedure.
As with erosion, perforation causes a lot of internal damage. It may occur because of erosion that wasn’t detected until it was too late and the mesh moved through tissue to puncture other organs. According to the FDA, nearly six percent of reports of adverse events with transvaginal mesh involved perforation of one or more organs. Perforation nearly always requires surgeries to repair damage, but some women are left with permanent damage.
Additional Side Effects
Erosion and perforation cause multiple complications in most women who experience them. The most common and obvious are pain, bleeding, and infection. Other possible complications include recurrence of the original condition, POP or SUI, damage to nerves, permanent scar tissue, urinary retention, bruising, vaginal discharge, fistulas, and hematomas.
Some women experiencing erosion and perforation from transvaginal mesh have even had more serious complications. For instance, some women suffered so much damage to the colon that colostomies were required. It is also possible that perforation of the colon can cause leakage of infectious waste into the blood leading to sepsis, which can be fatal.
The surgery itself to correct damage caused by transvaginal mesh, can cause its own side effects and complications. Many women have needed multiple surgeries causing pain and long recovery times. Potential complications of all the surgeries include excessive bleeding, infections, and dangerous blood clots.
Side Effect Lawsuits
Because of the severity of what women have experienced with transvaginal mesh procedures, a number of them have filed lawsuits. Manufacturers of transvaginal mesh that have been sued include C.R. Bard, Cook Medical, Ethicon, American Medical Systems, Boston Scientific, and others. Several of these companies have paid settlements in the millions of dollars to these women. They were accused of not warning patients about the risks of transvaginal mesh and not ensuring that the medical practitioners using it were adequately trained.
If you were harmed by a transvaginal mesh procedure, you may still be able to start a lawsuit and seek compensation. The severity of the potential side effects of this medical product is such that you may be facing thousands of dollars in medical bills, loss of income from being unable to work, and a future of pain because of permanent damage. You are not the only one who may feel wronged by the companies that made this product. So many women have suffered needlessly and many have gotten the compensation they deserve. You can speak with a lawyer to find out what your options are and to get the advice you need to make a case and get your own compensation for pain and suffering.