For women who have undergone transvaginal mesh (TVM) surgery, the subsequent pain and discomfort is often immediate. The surgery is meant to fix painful pelvic organ prolapse (POP) and stress urinary incontinence (SUI) disorders, but in many cases it causes more pain and discomfort. The leading cause of this pain is eroded mesh that causes organ perforation.
According to the Food and Drug Administration (FDA), organ perforation is one of the most reported adverse events associated with POP procedures. The FDA’s database showed that from 2008 to 2010, three women who had undergone TVM surgery to repair SUI died as a result of mesh organ perforation.
Organ perforation, including bladder, bowel, urethral and vaginal perforations, are common among the different types of TVM procedures.
Vaginal Mesh Complications
Since TVM kits became available in the mid 1990s for gynecological procedures, women have been suffering the medical consequences. All of the TVM kits on the market today are modeled after Boston Scientific’s ProteGen Sling, which was voluntarily recalled in 1996 after dozens of medical problems including mesh erosion and organ perforation. Still, that didn’t stop medical device manufacturers from making more faulty products. Because FDA rules allow devices that are “substantially similar” to enter the market without clinical trials or human testing, dozens of TVM products are being sold today. They all run the risk of causing severe medical complications.
Vaginal Mesh Recall
While the FDA has yet to issue an industry-wide recall, several mesh manufacturers have issued recalls on their own. These have only happened after patients came forward and filed lawsuits following their debilitating injuries. At the same time, the FDA has ordered manufacturers to launch ongoing studies into the dangers of TVM. None have reported any findings thus far. The FDA is also moving toward changing the device classification to ensure that future TVM products undergo rigorous premarket testing.
Organ Perforated Following TVM Surgery
In the meantime, however, women have been suffering the consequences of the device. The signs and symptoms of organ perforation can come on quickly after surgery in some cases, but in other cases it could take weeks.
Organ perforation is a result of mesh erosion, which is a common problem with TVM. When the flexible, plastic mesh erodes, it leaves small, sharp pieces of materials that can easily slice through, or perforates, nearby organs. In some cases, this can happen the bladder or rectum, which could cause urine or fecal matter to seep into the blood stream. This could lead to dangerous infections.
For all women who have undergone TVM surgery, it’s important to determine if your mesh has started to erode. The surgical procedure to remove mesh is very complicated and can take several attempts. Those who have already started suffering the aftereffects of organ perforation know that it is not easily treated. For this reason and others, it is important to have not only a skilled medical team on your side but also an experienced legal team handing your case. TVM removal is a long and expensive procedure that can overtake your life. Our team of experts will help you traverse the medical and legal world for your best possible outcome.