Much attention has been directed at the manufacturers of transvaginal mesh due to thousands of reports of serious complications and growing vaginal mesh lawsuit claims being filed by women throughout the United States. From recurring urinary tract infections and vaginal drainage to bleeding, back pain, and even mesh erosion through the vaginal wall, women have complained of serious side effects. The Food and Drug Administration notified the public in October 2008 that undergoing vaginal mesh placement for treatment of pelvic organ prolapse (POP) could result in severe consequences. But the agency noted that such pelvic mesh complications were rare. Since 2008, this statement has proven to be inaccurate. There is currently on vaginal mesh recall covering all mesh products.
On July 13, 2011, the FDA issued an update regarding problems associated with surgical mesh, particularly in cases where the device is implanted through the vagina. Complications were described by the agency as “not rare.” Nearly 500 transvaginal mesh lawsuit claims have since been filed. This number is expected to grow substantially.
Below, we’ll address several questions about pelvic mesh (sometimes called a bladder sling) and the problems it causes. The following details will help you to decide whether you should pursue a surgical mesh lawsuit claim for your injuries.
What Is Transvaginal Mesh?
Surgical mesh has been used for decades to treat hernias. Surgeons began to use it to treat POP and stress urinary incontinence (SUI) in the 1990s, but did so via abdominal surgery. The device was implanted to reinforce the vaginal wall, and help return the prolapsed organs to their normal positions.
Surgeons soon started to implant the medical device transvaginally because it was a less invasive approach than abdominal surgery. In the early 2000s, several companies started to produce mesh kits that were designed for vaginal placement.
What Are The Most Common Vaginal Mesh Complications?
The FDA noted several common complications in their July 2011 report. They highlighted the erosion of the device through the vaginal wall, recurring infections, pain during intercourse, and bleeding. Urinary issues were also described as common. In addition, many women have reported vaginal drainage and persistent back pain.
The agency reported that there is a high risk of bowel and bladder perforations during the procedure. Trauma to the blood vessels can also occur.
Can Mesh Erosion Be Treated?
Pelvic mesh erosion (also called extrusion) can usually be treated successfully if the surgeon has extensive experience. Treatment involves removing the device from the injured tissue. In some cases – for example, when erosion is severe or when the device has eroded through the wall of the bladder or rectum – surgeons have been unable to retrieve it. Unfortunately, this leaves the patient exposed to chronic pain, infection, and other problems.
How Did Vaginal Mesh Products Gain Approval From The FDA?
Most of the transvaginal mesh devices on the market were approved for sale through the FDA’s accelerated 510(k) approval process. This process does not require manufacturers of medical devices to subject their products to rigorous testing via clinical trials. Instead, the companies merely need to demonstrate their devices are “substantially equivalent” to others that have already been approved for sale.
Many experts have claimed this process allows manufacturers too much flexibility at the cost of protecting the public’s safety.
I’m Experiencing Pain During Sex. Can This Be Treated?
In most cases, yes. Pain during intercourse is an outcome of mesh erosion. As mentioned earlier, erosion of the device can be treated. However, removing it from the injured tissue – whether the vagina, bladder, or rectum – can sometimes prove to be problematic.
What Should I Do If I’m Experiencing Vaginal Mesh Complications?
Your first priority should be your health. If you underwent transvaginal placement of mesh for POP or SUI repair, and are now experiencing problems, consult your physician. If possible, speak with the surgeon who installed the device. Inform him or her of the problems you’re experiencing, and ask about treatment options. Then, consult a pelvic mesh lawyer.
The current group of vaginal mesh lawsuit claims allege the manufacturers of the devices were negligent in several ways. For example, they failed to sufficiently test the devices prior to offering them for sale; they designed them without adequate regard to their safety; and they failed to inform women of the potential complications they might be forced to endure. If you have experienced bleeding, recurring infections, pain during intercourse, or other side effects, contact us to discuss your legal options and the latest vaginal mesh recall news.