Transvaginal Mesh Revision Surgery
Women who suffer complications related to vaginal mesh implantation frequently must undergo one or more transvaginal mesh revision surgeries. Sometimes surgery relieves the pain and other side effects, but when it does not, product liability attorneys at The Sanders Firm can help determine whether compensation is available and advise you about your options.
Transvaginal mesh uses and side effects
For over fifty years, surgeons have used surgical mesh in hernia operations to help provide structural support for internal organs. Later, surgeons began using pelvic mesh for pelvic organ prolapse (POP), in which the bladder and other organs sag into the vagina due to tissues weakened by childbirth, aging, or other causes.
By the 1990s, surgical mesh was being used in transvaginal surgeries to treat both POP and stress urinary incontinence (SUI), in which urine can leak every time a woman coughs or laughs. However, women implanted with surgical mesh quickly began reporting serious side effects.
According to the FDA, pelvic mesh complications include:
- Mesh erosion through the vagina
- Severe pain
- Pain during sexual intercourse (dyspareunia)
- Organ perforation
- Urinary problems
- Recurrent prolapse
- Neuro-muscular problems
- Vaginal scarring/shrinkage
- Emotional problems
The FDA approved the first transvaginal mesh in 1996, the ProteGen product made by Boston Scientific. After 123 reports of serious complications, Boston Scientific recalled over 20,000 ProteGen devices. But similar devices manufactured by other companies remained on the market, and have since been the source of serious complications requiring transvaginal mesh revision surgery.
FDA bombarded with adverse events reports
In 2008, the FDA issued a Public Health Notification and Additional Patient Information that identified serious complications associated with transvaginal placement of surgical mesh to treat both POP and SUI. The agency noted that it had received over 1,000 reports of serious adverse events from doctors and patients 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 surgical mesh – nearly three times the number received in the preceding three-year period. As a result, in 2011, the FDA conducted a formal review of the scientific studies regarding transvaginal mesh placement. The agency assessed 110 studies involving 11,785 women and concluded that “mesh-associated complications are not rare.”
To the contrary, according to the FDA, “approximately 10 percent of women undergoing transvaginal POP repair with mesh experienced mesh erosion within 12 months of surgery. More than half of the women who experienced erosion from non-absorbable synthetic mesh required surgical excision in the operating room. Some women required two to three additional surgeries.”
Transvaginal mesh revision surgery
As part of its 2011 report, the FDA issued new recommendations for health care providers regarding transvaginal surgical mesh. Before placing mesh, doctors were advised to consider that its transvaginal use might put the patient at risk of additional surgery or new side effects.
The FDA cautioned further that “[r]emoval of mesh due to mesh complications may involve multiple surgeries and significantly impair the patient’s quality of life. Complete removal of mesh may not be possible and may not result in complete resolution of complications, including pain.”
One pelvic surgeon gave a graphic description of surgical mesh removal in testimony before the FDA in September 2011:
“Extirpation of vaginal mesh is akin to taking a hammer and chisel and trying to remove the rebar from a sidewalk while leaving the cement otherwise intact and not damaging the water mains and power lines below. It is difficult if not impossible to remove all the mesh and do it safely.”
Unfortunately, women’s experience has borne out the FDA’s warnings concerning revision surgery. A Texas woman reported undergoing six operations and 11 other medical procedures after the mesh eroded and began to perforate her bladder. Doctors were unable to remove the entirety of the mesh because it had become embedded in her tissue. “It’s like removing gum from your hair,” she said.
Six other women from around the country testified before the FDA’s September 2011 advisory panel. All had had surgical mesh implanted to treat pelvic organ prolapse or stress urinary incontinence. And all had experienced side effects that they identified as worse than the original conditions, including infections, nerve damage, excruciating pain, an inability to sit down or urinate without a catheter, repeated hospitalizations, and an end to their sex lives.
Among them, the six women had undergone 45 transvaginal mesh revision surgeries.
Life-shattering injuries prompt transvaginal mesh lawsuits
Over 37,000 women who have suffered transvaginal mesh side effects are seeking compensation for their losses by filing lawsuits against the products’ manufacturers. At The Sanders Firm, we have worked with many such victims. Our expert medical consultants, veteran investigators, and experienced personal injury lawyers can evaluate each woman’s situation and determine whether compensation is available. Over the years we have helped thousands of innocent victims recover for their pain and suffering, past and future medical bills, emotional damages, and lost income, among other losses.
More than 25,000 vaginal mesh lawsuits have been centralized under multidistrict litigation in federal court for pretrial proceedings. Seven MDLs are currently underway in the Southern District of West Virginia, where Judge Joseph Goodwin is overseeing all pretrial motions and bellwether trials.
To date, a handful of women have been compensated for their transvaginal problems and injuries in both state and federal court. In 2012, a jury in California awarded $5.5 million to a woman whose implantation required eight revision surgeries and nine additional medical procedures.
In February 2013, a jury in New Jersey ordered Johnson and Johnson to pay $11.1 million to a woman who required 18 mesh revision surgeries. The jury found that the company acted in “wanton and willful disregard” of the patient, justifying $7.76 million in punitive damages on top of the $3.35 million it awarded to compensate the plaintiff for her medical expenses, pain and suffering, and lost income.
Speak to a product liability attorney
The Sanders Firm attorneys have a national reputation for assisting victims of defective medical devices recover for their losses, helping them attain a measure of justice along with maximum compensation for their injuries.
We know that no monetary award can ever make up for the excruciating pain caused by transvaginal mesh complications, but financial compensation can help ease the day-to-day concerns of women and their families who have been harmed by these devices. If you have been harmed, we invite you to contact our offices for a free and confidential consultation. We will take your call at any time, on any day, without any charge or obligation on your part. Please call 1.800.FAIR.PLAY
- WBUR Common Health, “Surgery Under Scrutiny: What Went Wrong with Vaginal Mesh,” November 4, 2011 http://commonhealth.wbur.org/2011/11/surgery-under-scrutiny-what-went-wrong-with-vaginal-mesh
- Bloomberg, “J&J Vaginal mesh Approved by FDA Based on Older Recalled Device,” October 20, 2011 http://mobile.bloomberg.com/news/2011-10-20/j-j-vaginal-mesh-approved-by-fda-based-on-older-recalled-device?category=%2Fnews%2Fmostread%2F
- FDA, “Urogynecologic Surgical Mesh: Update on the Safety and Effectiveness of Transvaginal Placement for Pelvic Organ Prolapse,” July 2011, http://www.fda.gov/downloads/medicaldevices/safety/alertsandnotices/ucm262760.pdf
- 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
- Bloomberg, “J&J owes $7.76 million in punitives in vaginal mesh case,” February 28, 2013, http://www.bloomberg.com/news/2013-02-28/j-j-owes-7-76-million-in-punitives-in-vaginal-mesh-case.html