When transvaginal mesh kits were originally marketed to urologists and gynecologists, the device makers presented them as a way to achieve higher success rates for pelvic organ prolapse and incontinence repairs. However, there was no evidence from clinical trials to document either the effectiveness or safety of transvaginal mesh.
As surgeons performed more procedures using transvaginal mesh, they found that there were several adverse reactions ranging from mild to serious, including painful intercourse, and pelvic and groin pain. However, these can occur with reconstructive surgery of the pelvis even if mesh isn’t implanted.
The adverse reaction that is unique to transvaginal mesh surgery is erosion. This occurs when the mesh device gradually moves through the vaginal wall and sometimes into surrounding organs.
|Mesh erosion can cause the following complications:|
|Damage to the bladder and/or bowel.|
|Recto-vaginal fistula. This is a small tunnel that connects the rectum with the vagina that results from the mesh device having moved out of place.|
|Abscess –This is a pus-filled sore.|
These complications will make it necessary for the patient who had the mesh device implanted to have additional surgeries to remove the device and repair damage.
Complications Include Mesh Erosion
Over the last eight years, there has been an increase in the use of synthetic mesh to treat pelvic organ prolapse (POP) and stress urinary incontinence (SUI). Both conditions can occur when the supporting muscles in the floor of the pelvis that hold it in place become weakened.
Prolapse occurs when one or more of the pelvic organs — including the vagina, cervix, uterus, bladder, urethra and rectum — sinks into the vagina. Incontinence occurs when the muscles controlling the bladder become weak and allow urine to leak out during physical activities.
|The most common symptoms or prolapse are:|
Many women experience some form of pelvic organ prolapse or incontinence as a result of childbirth and aging.
|Pressure within the pelvic region|
|Bulging tissue in the area|
|Protruding organs that go up to or past the vaginal opening|
|Discomfort during intercourse|
For prolapse, transvaginal mesh is permanently implanted to reinforce the pelvic floor, which should hold the pelvis in its correct position and alleviate symptoms. For incontinence, a small piece of mesh — called a bladder sling — is inserted to create a surgical hammock to support the bladder.
In October 2008, the Food and Drug Administration (FDA) issued a warning to surgeons about the problems associated with transvaginal mesh based on more than 1,000 reports of complications the agency received about transvaginal mesh surgeries from 2005 to 2007.
As a part of its alert, the FDA noted that there has been no determination of the specific factors that cause patients to be at increased risk for complications. The list of potential contributing factors may include the health of the patient, the mesh used, the surgical technique, concomitant procedures (additional surgical procedures that are performed during the same operation, such as a hysterectomy), and estrogen status.
|The FDA also issued a set of recommendations for surgeons, including:|
|Obtain special training for every mesh placement procedure, and be aware of the risks.|
|Watch for adverse events, specifically erosion and infection.|
|Check for complications related to the implantation, specifically bowel, bladder and blood vessel perforations.|
|Inform every patient that the implantation of mesh is permanent, and that certain problems may require revision surgery that may or may not fix the complication.|
In July 2011, the FDA issued another warning because it had received an additional 2,874 reports of complications associated with surgical mesh devices used to repair pelvic organ prolapse and incontinence from 2008-2010.
The most frequent complications included mesh erosion through the vagina, pain, infection, bleeding, painful intercourse, organ perforation, and urinary problems. Many of these complications required medical or surgical treatment and hospitalization.
Transvaginal Mesh Lawsuits
Thousands of women have filed lawsuits against the manufacturers of surgical mesh products after experiencing serious complications. They are seeking compensation for:
- Medical expenses, including the costs of additional surgeries
- Loss of wages
- Loss of spousal consortium
- Losses to quality of life
- Pain and suffering
In Canada, a class-action lawsuit has been filed against Johnson & Johnson.
In the United States, six multidistrict litigations brought against a number of models of mesh implants have been consolidated and transferred to the U.S. District Court for the Southern District of West Virginia. The manufacturers included in this consolidation are: C.R. Bard Inc., Johnson &Johnson, Boston Scientific Corp. American Medical Systems, Coloplast and Cook Medical.
Trial is set for July 2013 for the first of thousands of federal cases alleging that Bard’s devices caused organ damage or other complications.
A separate MDL involves lawsuits over Mentor ObTape, which is a bladder sling. That MDL is located in the U.S. District Court for the Middle District of Georgia.