Serious Side Effects From Transvaginal Mesh
Over the last decade, thousands of women have undergone laparoscopic surgery to have transvaginal mesh products inserted through the vagina. These mesh devices are used to treat two conditions: pelvic organ prolapse (POP) and stress urinary incontinence (SUI). The manufactures of these mesh devices have contended that inserting the mesh through the vagina (transvaginally) is superior to a traditional open operation (inserting the mesh through an incision in the abdomen), since the transvaginal approach is less invasive, causes less blood loss, and results in a quicker recovery from surgery. However, a significant percentage of woman who have undergone transvaginal mesh surgery have suffered serious and permanent side effects, including erosion of the mesh through the vagina, infection, pelvic pain, bleeding and pain during sexual intercourse.
FDA Statement from July 2011 Raises Serious Concerns about the Safety of Transvaginal Mesh Products
On July 13, 2011, the U.S. Food and Drug Administration (FDA) issued a statement which called into question the safety of transvaginal mesh devices. The document stated that “the FDA is issuing this update to inform you that serious complications associated with surgical mesh for repair of POP (pelvic organ prolapse) are not rare.” The FDA statement also explained that “it is not clear that transvaginal POP repair with mesh is more effective than traditional non-mesh repair in all patients with POP and it may expose patients to greater risk.” Thus, the FDA had concluded that there were significant complications associated with transvaginal mesh surgery, that these complications were not uncommon, and that transvaginal mesh surgery was not any safer than other forms of surgery available to treat pelvic organ prolapse and stress urinary incontinence. Less than a year after the FDA statement was released, Johnson & Johnson announced that it was stopping the sales of its transvaginal mesh products. However, several other companies have continued to market and sell their transvaginal mesh devices.
More than 60,000 Women have Filed Lawsuits Against the Manufacturers of Transvaginal Mesh Devices
As of September, 2014, approximately 67,000 lawsuits have been filed against transvaginal mesh manufacturers. Additional lawsuits are being filed every day. Several of these lawsuits have already proceeded to trial, and many have resulted in verdicts in favor of the patient. Many of these cases are consolidated in federal district court in West Virginia.
Frequently Asked Questions Regarding Transvaginal Mesh Lawsuits
What are transvaginal mesh devices used for?
These devices are used to treat two medical conditions: stress urinary incontinence and pelvic organ prolapse. Stress urinary incontinence occurs when coughing, sneezing, or sudden movement causes a small amount of urine to leak out. This condition becomes more common in older women, as well as women who have given birth. Pelvic organ prolapse occurs when the muscles and ligaments that support the organs in the pelvis become weakened or stretched; this can then lead to “prolapse” or drooping of the pelvic organs (small bowel, vagina, bladder, uterus, and rectum). Common causes of pelvic organ prolapse include childbirth, hysterectomy, and obesity.
What are the side effects associated with transvaginal mesh devices?
According to the FDA, “erosion of the mesh through the vagina is the most common and consistently reported complication from transvaginal POP surgeries using mesh.” Mesh erosion commonly leads to pelvic pain, urinary problems and permanent nerve damage. A 2011 article from the New England Journal of Medicine concluded that women who had received a mesh implant were seven times more likely to suffer a bladder perforation when compared with women who underwent traditional vaginal repair surgery. In addition, those undergoing transvaginal mesh implant surgery also sustained more intraoperative blood loss, and experienced longer surgery times. All of the following complications have been associated with transvaginal mesh implants:
- pelvic pain
- permanent nerve damage
- recurrence of pelvic organ prolapse or stress urinary incontinence
- bowel or bladder perforation during surgery
- pain during sexual intercourse
- mesh erosion through the epithelium
- urinary problems
- scarring of vaginal tissue
What is wrong with the transvaginal mesh devices?
According to the patients who have filed lawsuits, the transvaginal mesh devices are not designed properly and the manufacturers failed to warn patients and doctors about the known risks associated with the devices. The mesh devices are known to move after they have been placed during the surgery. When the mesh moves, it can cause erosion through the vagina, which can lead to debilitating pain and/or damage to surrounding organs. The mesh devices can also contract (shrink) after placement, and this leads to vaginal shortening, vaginal tightening, and vaginal or pelvic pain.
How many transvaginal mesh lawsuits have been filed?
As of September, 2014, more than 60,000 women had filed lawsuits against the mesh device manufacturers. Some of these cases have already proceeded to trial.
Who are the defendants in the transvaginal mesh lawsuits?
There are several companies who manufacture and distribute transvaginal mesh products, including C.R. Bard, Inc., American Medical Systems, Johnson & Johnson’s Ethicon division, and Boston Scientific.
How do I know if I should file a lawsuit for my transvaginal mesh device?
If you have suffered any side effects from your transvaginal mesh device, you should speak to an attorney who is experienced in handling transvaginal mesh cases. In particular, if you have had to undergo a revision surgery to remove the mesh, it is likely that you have a claim for compensation.
Why should I hire the Mahoney Law Firm, P.C. for my transvaginal mesh lawsuit?
The attorneys in our firm have many years of experience handling defective product cases. In addition, one of the attorneys in our firm, Dennis Mahoney, M.D., is not only a medical doctor, but he is an obstetrician-gynecologist. Dr. Mahoney has performed gynecologic surgery, and he is uniquely qualified to understand how the mesh products are placed and how they can lead to injuries.
Find Out If You Are Eligible For The Transvaginal Mesh Lawsuit
If you or a loved one has been injured as a result of a transvaginal mesh product, please contact The Mahoney Law Firm, P.C. for a free consultation to determine if you are eligible to participate in lawsuit and receive compensation for your injuries. Call us today at 303-800-3168.