Vaginal Mesh Damage
Transvaginal mesh was introduced in 2002 as a treatment for incontinence occurring in women after childbirth, menopause, or hysterectomy. Incontinence occurs when ligaments inside the pelvis become stretched, making the uterus to press on the bladder. It was hoped that a surgical procedure to implant vaginal mesh would resolve these incontinence problems, but now many women who received the implanted mesh are facing devastating injuries as a result of erosion and decay of mesh into their vaginal wall. As a result, women are facing not only multiple repair surgeries, but chronic pain and recurring infection.
Women who have received the Mentor ObTape and the American Medical Systems Monarc transobturator slingshave been found to be particularly at risk from the transvaginal mesh failing. The FDA has received a high number of adverse effect reports which point to a higher than usual failure rate for these particular types of transvaginal mesh.
Concerns about transvaginal mesh and the recent outbreak of other defective medical devices has led to call from congressional Democrats for a formal investigation and congressional hearings about these devices.
Vaginal Mesh Implants Ineffective, Dangerous
Transvaginal Mesh was introduced in 2002. Despite their inherent risk, medical devices such as transvaginal mesh implants actually undergo less testing than new pharmaceuticals. Within five years of vaginal mesh being implanted in patients, it began to become clear that this medical device posed serious risks.
Transvaginal mesh has the potential to begin decay and erode quickly after insertion, exposing women who have received the implant to serious risks, including surgical attempts to remove the mesh.
One of the serious risks associated with decaying transvaginal mesh is that it can travel through the body. Tiny fragments of the mesh, measuring only a few millimeters, can become randomly lodged elsewhere in the body, causing inflammation and infections.
F.D.A. Orders Surgical Mesh Makers to Study Risks
On January 4th, 2012 the FDA ordered manufacturers of transvaginal mesh to conduct studies on the risks of their products, with an additional report expected to be released in September of 2012.
- The New York Times reported that the FDA's increased scrutiny came after years of reports of serious injuries linked to the devices, including infections, pain and other complications.
- Bloomberg reported that nearly 300,000 women have had vaginal mesh implants in the United States. More than 600 lawsuits have already been filed and the FDA has come under increased scrutiny for allowing the products on the market without human testing.
- In a story in The Washington Post, it was noted that the FDA is considering reclassifying the mesh as a high-risk device. This would mean that manufactures would be required to assess the device's safety before launch. Unfortunately, such a reclassification could take years.
Transvaginal Mesh in the News
- How Safe Are Medical Devices?
- FDA Safety Communication: UPDATE on Serious Complications Associated with Transvaginal Placement of Surgical Mesh for Pelvic Organ Prolapse
- The incontinence operation that's ruining women's lives
- Vaginal Mesh: New FDA Warnings
- Brevard women sue over mesh devices
- Trial of Synthetic Mesh in Pelvic Surgery Ends Early
- Vaginal Mesh: Proceed At Your Own Risk
- FDA warns mesh used in surgery poses risk
- FDA cites risks of implant used to strengthen vaginal tissue
The FDA's January action was the second time the agency had issued warning about vaginal mesh within a single year. On July 13 of 2011, the FDA issued an alert to physicians and patients, linking vaginal mesh to a number of complications, including erosion through vaginal epithelium, infection, pain, and urinary problems. The FDA also said that there have been reports of bowel, bladder, and blood vessel perforation during insertion.
These side effects were considered to be serious, causing chronic pain in some patients and significantly impacting the woman’s quality of life.
The FDA also discovered that the mesh generally failed at its original purpose, finding that there was little evidence that the device improved pelvic organ prolapse.
Unfortunately, medical options for treatment of the symptoms of failed transvaginal mesh are limited. Some women have undergone multiple operations to attempt to remove the mesh, but surgeons say it is impossible to get it out completely.
- A 2007 clinical trial of transvaginal mesh was halted early, when safety reviewers observed that more than 15 percent of the patients who received the mesh experienced erosion, a potentially serious complication in which the skin splits and the mesh protrudes, often resulting in pain and infections.
- In 2008, the FDA issued a warning of serious complications with surgical mesh for transvaginal repair of pelvic organ prolapse. The FDA initially reported that these complications were rare, but in 2011 the FDA revised this ruling, issuing a new warning saying that the complications are not rare.
With medical options limited and the prospect of a lifetime of pain ahead of them, many women who have been injured by vaginal mesh are finding that seeking recourse through a lawsuit is the only action available to them.
Experienced Vaginal Mesh Attorneys
The law firm of Blizzard & Nabers are experienced at handling vaginal mesh litigation. Our attorneys are specialists in medical device litigation, and for more than 25 years we have successfully represented our clients and stood up for the rights of people harmed by defective medical devices. We are a nationwide law firm serving clients from all over the country. We handle all vaginal mesh injury cases on a contingency basis.
To learn more, or for a free consultation with an experienced vaginal mesh attorney, please contact us by email or call us at 1-800-349-0127.