Pelvic Organ Prolapse (POP)
Transvaginal mesh (TVM) has often been used to treat pelvic organ prolapse (POP), but unfortunately implanting the device can cause POP to recur or get worse.
If you are suffering this transvaginal mesh complication, product liability lawyers at The Sanders Firm can help. We encourage you to contact us for a no-obligation and completely confidential discussion of your situation and the legal options it presents.
What is pelvic organ prolapse?
Pelvic organ prolapse occurs when the bladder and other organs sag into the vagina as a result of tissue weakened by childbirth, menopause, hysterectomy, or other causes.
There are several different types of POP, including
- Cystocele, also called prolapsed bladder, occurs when the tissue between the bladder and the vaginal wall weakens, allowing the bladder to protrude into the vagina
- Rectocele, or posterior prolapse, involves weakening of the tissue separating the rectum from the vagina; typically the front wall of the rectum bulges into the vagina
- Uterine prolapse is diagnosed when the muscles and ligaments of the pelvic floor stretch and weaken, providing insufficient support for the uterus and permitting it to slip into or bulge out of the vagina
- Enterocele, which is also called small bowel prolapse, takes place when the small intestine drops into the lower part of the pelvic cavity and creates a bulge at the top of the vagina
Mild or moderate symptoms of POP may be controlled by weight loss (for the obese), dietary changes to prevent constipation, avoidance of heavy lifting, and similar lifestyle modifications. In some instances, women may be advised to use a pessary, which is a removable device similar to a diaphragm that is inserted into the vagina. However, when POP becomes painful or interferes significantly with daily activities, surgery may be required.
Transvaginal mesh used to treat POP
For over fifty years, surgeons have used surgical mesh in hernia operations to help provide structural support for internal organs. In the 1970s, surgeons began using the mesh in abdominal repairs for POP. Surgeons were using mesh in transvaginal surgeries to treat POP by the mid-1990s.
In 1996, the FDA approved the first transvaginal mesh device for use in the United States, which was Boston Scientific’s ProteGen. However, after 123 women reported serious mesh complications, Boston Scientific recalled over 20,000 ProteGen devices. Other companies had manufactured similar devices that remained on the market, and their use continued.
Surgeons use transvaginal mesh to treat pelvic organ prolapse by implanting the device in the vagina in order to strengthen the weakened portion of the vaginal wall. In some cases, surgeons employ mesh to reinforce the urethra.
Unfortunately, however, many women who have undergone transvaginal mesh surgery have experienced serious side effects.
According to the FDA, transvaginal mesh complications include:
- Mesh erosion through the vagina
- Recurrence of POP
- Severe pain
- Pain during sexual intercourse (dyspareunia)
- Organ perforation
- Urinary problems
- Neuro-muscular problems
- Vaginal scarring
- Emotional problems
- Pain experienced by male partner during sexual intercourse
FDA warns about mesh complications
In 2008, the FDA issued a Public Health Notification and Additional Patient Information noting that it had received over 1,000 reports of serious adverse events from doctors and patients regarding mesh products between 2005 and 2007. The FDA concluded that using mesh for transvaginal repair of POP was “an area of continuing serious concern.”
Between 2008 and 2010 the FDA received 2,827 reports of serious adverse events connected with transvaginal mesh – nearly three times the number received in the preceding three-year period. In response, in 2011 the FDA formally reviewed the scientific studies regarding transvaginal mesh use and side effects. The agency assessed 110 studies involving 11,785 women and concluded that “[m]esh-associated complications are not rare.” Instead, the FDA noted that “approximately 10 percent of women undergoing transvaginal POP repair with mesh experienced mesh erosion within 12 months of surgery.”
Lawsuits charging transvaginal mesh side effects
As of April 2014, over 55,000 transvaginal mesh lawsuits had been filed by women seeking compensation for their injuries. Up to half a million transvaginal mesh implantations have been performed every year since the mid-1990s. Given the many injuries that have resulted from these surgeries to date, we anticipate that thousands more women will suffer serious complications in the future.
At The Sanders Firm, we have dedicated our working lives to representing victims of defective medical devices and dangerous drugs. We consult expert medical practitioners to assess the nature and extent of each woman’s injuries, and provide guidance about future treatments. We also work closely with skilled investigators, who gather and evaluate all the financial and medical records needed to support a victim’s damages claim.
We have more than four decades of experience helping victims recover for their pain and suffering, past and future medical bills, emotional damages, and lost earnings, among other losses.
Litigation over TVM injuries
Many transvaginal mesh lawsuits have been centralized for pretrial processing before Judge Joseph R. Goodwin in federal court in West Virginia. To date, seven multidistrict litigations (MDLs) are pending in that court. In addition, a number of TVM lawsuits have been filed in state courts around the country.
Thus far, several plaintiffs have been compensated for their transvaginal mesh complications and injuries. A California jury in 2012 awarded $5.5 million to a woman who was forced to undergo eight surgeries and nine additional medical procedures in order to treat her complications.
In 2013, Ethicon was ordered to pay $11.1 million to a New Jersey woman who required 18 mesh revision and repair surgeries. The jury awarded $7.76 million in punitive damages based on the company’s “wanton and willful disregard” of the patient. The plaintiff also recovered $3.35 million in compensation for her medical expenses, pain and suffering, and lost income.
Transvaginal mesh lawyers you can count on
The Sanders Firm personal injury attorneys have over 46 years of experience representing individuals who were harmed through the negligence of others. You can rely on us to do everything necessary to secure the compensation you are due. And we never charge a fee unless you recover for your injuries. For a free initial case evaluation with a member of our legal team, please call us today at 1-800-FAIR-PLAY.
- Mayo Clinic, “Pelvic Organ Prolapse,” http://www.mayoclinic.org/diseases-conditions/pelvic-organ-prolapse/basics/definition/con-20036092
- U.S. District Court for the Southern District of West Virginia, “Multidistrict Litigation,” http://www.wvsd.uscourts.gov/
- FDA, “FDA Safety Communication: UPDATE on Serious Complications Associated with Transvaginal Placement of Surgical Mesh for Pelvic Organ Prolapse,” July 2011, http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm262435.htm
- Fox News, “Jury awards $3.35 million in vaginal mesh case against Johnson & Johnson,” February 26, 2013, http://www.foxnews.com/health/2013/02/26/jury-awards-335-million-in-vaginal-mesh-case-against-johnson-johnson/