Transvaginal Mesh Complications
At The Sanders Firm, we represent women who sought relief from pelvic organ prolapse (POP) and other conditions, only to suffer serious, even life-altering transvaginal mesh complications. Problems such as mesh erosion and extrusion, infections, incontinence, vaginal scarring and constant pain can have a devastating effect on your quality of life, and require extensive treatment and revision surgery. In some cases, surgical mesh complications may not be fully treatable.
If you are in such a distressing situation, it is understandable that you have questions and concerns regarding how you will cope financially, why you were not properly warned of potential complications, and what your next course of action should be. Our product liability lawyers are experts in the vast surgical mesh litigation currently ongoing across the country. We can answer your questions, and help to lay out the best and most productive legal course of action for you and your family.
We will do everything in our power to make sure you receive the maximum compensation allowed to you by laws should you chose to pursue a defective medical device lawsuit.
Transvaginal mesh FDA warnings and studies
At The Sanders Firm, we want you to know that if you have experienced serious transvaginal mesh side effects, you are not alone. Transvaginal mesh (also called pelvic mesh) is frequently included as part of a sling- or hammock-like device that most commonly treats pelvic organ prolapse (POP) or stress urinary incontinence (SUI). The devices, sold under different names by several firms, were originally cleared by the FDA in the 1990s; however, between 2005 and 2008, the FDA received over 1000 reports of serious transvaginal mesh complications. On October 20, 2008, the FDA issued a warning, noting that “[a]lthough rare, these complications can have serious consequences.”
However, further studies suggested that transvaginal mesh side effects occurred more frequently than had been recognized previously. For instance, a research trial begun in 2007 and stopped in August of 2009 found that 15.6 percent of women who underwent surgery with vaginal mesh experienced serious side effects. The study, results of which were published in August of 2010 in the journal Obstetrics and Gynecology, comprised 65 women who underwent either transvaginal mesh surgery or colpopexy (an older procedure that supports weakened muscles using the patient’s own ligaments). The study also found that in addition to elevated risk, transvaginal mesh surgery did not offer more effective treatment compared to more traditional surgery.
In an updated warning from July 13, 2011, the FDA reported that after a review of published scientific literature it would amend its characterization of the frequency of transvaginal mesh complications, stating that they were, in fact, “not rare.” There were 1503 additional reports of complications from the procedure between 2008 and 2010.
Transvaginal mesh complications
A review of the reported side effects or complications from transvaginal mesh surgery supports the FDA’s grave concerns about the procedure.
Transvaginal mesh complications include:
- Mesh erosion (also called exposure, extrusion or protrusion): occurs when the mesh erodes the skin and tissue of the vaginal wall, sometimes becoming embedded in the wall or even protruding from the wall of the vagina.
- Infection: erosion can lead to chronic, painful infections of the area surrounding the vagina, whereas infections can further erode the mesh.
- Nerve and tissue damage: mesh has been known to shrink, leading to a tightening or shortening of the vagina and to nerve or tissue damage and pain.
- Organ puncture: mesh that has eroded through the walls of the vagina can puncture other organs, such as the bowels, bladder, and rectum.
- Chronic pain: many women report chronic, even excruciating, pain associated with the mesh; some women experience pain even after the mesh is removed.
- Inability to pass urine: erosion may also result in difficulty or inability to urinate
- Relapse of SUI and POP: many women have surgical implantation with transvaginal mesh in order to treat pelvic organ prolapse (POP, when the pelvic muscles weaken and allow other organs to collapse into the vagina) or stress urinary incontinence (SUI, common to women who are aging or who have given birth); unfortunately, these very conditions can return with mesh erosion.
- Problems with sexual intercourse: mesh erosion can lead to problems with or cessation of intercourse, including pain and discomfort so severe that woman find intercourse impossible, or the possibility that the protruding pieces of mesh can injure the penis of a partner.
- Revision surgery: many of these symptoms necessitate revision surgery. However, removing the mesh can be complex, and often has to be undertaken in several steps, can lead to worsening of the symptoms above or may not be effective.
If you have experienced any of these side effects as a result of the surgical implantation of transvaginal mesh, contact The Sanders Firm to discuss your legal options.
Transvaginal mesh lawsuits
Thousands of women have already filed lawsuits against seven of the companies that produce transvaginal mesh devices. These lawsuits have been consolidated as part of seven federal multidistrict litigations. The plaintiffs are suing for medical expenses, loss of income, pain and suffering, punitive damages, and (in some cases) loss of consortium.
If you have endured transvaginal mesh complications like the ones listed above, contact The Sanders Firm to explore your legal options. Already, some plaintiffs have won their cases in court with substantial judgments in their favor. For instance, Linda Gross was awarded $11.1 million in damages after her Gynecare Prolift system (manufactured by Johnson & Johnson) caused damage that forced her to endure 18 mesh repair surgeries.
With other plaintiffs winning their cases before a jury, at least some manufacturers may settle out of court. We believe that our clients will have an excellent chance to recover large judgments or settlements; however, you pay no legal fees unless we win your case or negotiate a settlement for you.
Please contact our firm at 1.800 FAIR PLAY (800.324.7752) to speak with one of our personal injury attorneys. The consultation will cost you nothing and can provide valuable information about a potential transvaginal mesh lawsuit resulting in the compensation you deserve for what you have suffered.
- FDA, Public Health Notification: Serious Complications Associated with Transvaginal Placement of Surgical Mesh in Repair of Pelvic Organ Prolapse and Stress Urinary Incontinence, http://www.fda.gov/medicaldevices/safety/alertsandnotices/publichealthnotifications/ucm061976.htm
- FDA, FDA Safety Communication: UPDATE on Serious Complications Associated with Transvaginal Placement of Surgical Mesh for Pelvic Organ Prolapse, http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm262435.htm
- FDA, Urogynecologic Surgical Mesh: Update on the Safety and Effectiveness of Transvaginal Placement for Pelvic Organ Prolapse, http://www.fda.gov/downloads/MedicalDevices/Safety/AlertsandNotices/UCM262760.pdf
- Common Health, Surgeons Challenge FDA Warnings On Vaginal Mesh, http://commonhealth.wbur.org/2011/08/surgeons-challenge-fda-warnings-on-vaginal-mesh
- NY Times, Women Sue Over Device to Stop Urine Leaks, http://www.nytimes.com/2009/05/05/health/05tape.html?_r=1&
- NY Times, Trial of Synthetic Mesh in Pelvic Surgery Ends Early, http://www.nytimes.com/2010/10/26/health/research/26complications.html
- Obstetrics & Gynecology, Vaginal Mesh for Prolapse: A Randomized Controlled Trial, http://journals.lww.com/greenjournal/Abstract/2010/08000/Vaginal_Mesh_for_Prolapse__A_Randomized_Controlled.9.aspx
- NY Times, Johnson & Johnson Unit to Halt Urinary Implants, http://www.nytimes.com/2012/06/06/business/johnson-johnson-unit-will-stop-selling-urinary-implants.html
- Bloomberg, J&J Owes $7.76 Million in Punitives in Vaginal Mesh Case, http://www.bloomberg.com/news/2013-02-28/j-j-owes-7-76-million-in-punitives-in-vaginal-mesh-case.html
- NY Times, Jury Orders J.& J. to Pay an Implant Patient, http://www.nytimes.com/2013/02/26/business/johnson-johnson-told-to-pay-3-35-million-in-vaginal-mesh-case.html