Transvaginal Mesh for POP and SUI: An Overview
WHAT IS IT?
A transvaginal mesh has been defined as a surgical device, with a net-like appearance, that is implanted transvaginally to a woman’s pelvic area to reinforce damaged or weakened vaginal walls for the repair of pelvic organ prolapse (POP) or to support the urethra or bladder neck to repair stress urinary incontinence (SUI).
Majority of mesh being used are the synthetic type (man-made) which may be absorbable or non-absorbable and those made from animals which are also called biologic mesh. A fourth type of surgical mesh is the composite type or a combination of the materials mentioned.
Surgical mesh commonly used for urogynecological procedures is the synthetic type which is porous and non-absorbable and usually uses the polypropylene material. That is why a lot of medical practitioners may refer to this device as polypropylene mesh aside from the other common names of pelvic mesh and surgical mesh.
When the procedure is referred to as transvaginal mesh surgery, this means the implantation of the surgical mesh is done through the vagina by making an incision in the vaginal skin and the supporting tissue (fascia). In contrast, the procedure may be done through the abdomen which may then be referred as transabdominal surgery.
WHY DO YOU NEED ONE? / WHAT IS IT USED FOR?
The use of surgical mesh implanted through a transvaginal procedure has become a popular method of repairing pelvic floor disorders such as pelvic organ prolapse (POP) and stress urinary incontinence (SUI). Transvaginal mesh surgery is actually one of the several approaches used in treating these conditions with the other methods now being termed as traditional procedures.
POP occurs when the muscles, ligaments, and connecting tissues supporting the pelvic organs become damaged or weakened causing the bladder, uterus, rectum, urethra, and small bowel to descend from its normal position towards the vaginal canal where it may result to the bulging of the vaginal wall. SUI results when the muscles and tissues supporting the bladder loses strength causing the unplanned release of urine during certain activities like coughing, jumping, lifting, running, and even sneezing.
Surgical mesh has been used by doctors since the 1950s for hernia treatment. In the 1970s, a number of surgeons began using mesh, cut to desired sizes, to repair organ prolapse and incontinence. It was not until 1996 that the Food and Drug Administration (FDA) cleared a product intended to treat SUI. Vaginal mesh device for the repair of POP was likewise cleared by the FDA in the early 2000s.
Before the release of the FDA’s advisory in July 2011, mesh kits accounted for about 33 percent of all POP surgeries while SUI repairs used these devices in 80 percent of the cases.
WHAT IS THE PROCEDURE?
The objective of the mesh implant is to reinforce pelvic tissues which have failed to provide support the pelvic organs. Support to the bladder, uterus, or bowel is expected to be restored thereby preventing the further descent and bulging of these organs towards the vagina.
A patient who will undergo vaginal mesh surgery may have to be placed under regional (spinal) or general anaesthetic. An incision is then made in the vaginal skin and the fascia which is the tissue supporting the vagina. This supporting tissue may have to be straightened using a number of stitches.
The surgical mesh is then inserted underneath the vaginal skin after which it will be closed using stitches. Within three to four weeks, the body’s tissues may grow into the mesh providing some sort of anchor. The stitches used to close the incision may also dissolve in one or two weeks.
After the completion of the procedure, a catheter is then inserted into the bladder for the draining of urine. To prevent bleeding, a gauze pack will be placed in the vagina which may be removed after two days. Antibiotics, which may be given during operations, may have to be continued for at least a week after the surgical procedure.
IS IT SAFE?
As early as 2005, there were already adverse reports submitted to the Food and Drug Administration (FDA) by patients questioning the safety and efficacy of these surgical mesh devices. After reviewing over a thousand of complaints, it released a notification in 2008 where it noted serious complications arising from the use of transvaginal mesh. However, no concrete actions were taken by the Agency aside from declaring that surgical mesh placed through the vagina for POP and SUI repair was an area of continuous serious concern.
In July 13, 2011, the FDA issued another Public Health Notification informing all concerned that serious complications associated with surgical mesh for transvaginal repair of POP are not rare. It further stated that it is not clear that transvaginal POP repair with mesh is more effective than traditional non-mesh repair in all patients with POP. More significantly, it declared that the use of transvaginal mesh devices may expose patients to greater risks.
Results of a recent study conducted in Europe involving 677 women from six different medical facilities who underwent vaginal mesh surgery revealed that 152 of the subjects or 17 percent experienced severe complications. The report of the Russian research team was presented to the European Association of Urology and published in Medical News Today on March 21, 2013.
WHAT ART THE COMPLICATIONS/ADVERSE EFFECTS
For the period January 1, 2008 to December 31, 2010, the agency received 1,503 reports of complications associated with surgical mesh devices used to repair POP and 1,371 for SUI repairs for a total of 2,874 adverse reports. This is on top of the earlier complaints received from 2005 to 2007 which totaled over 1,000.
After a thorough analysis of the adverse reports, it was able to come up with a list of severe complications associated with vaginal mesh devices.
These complications include the following:
- mesh erosion through the vagina (also called exposure, extrusion, or protrusion)
- chronic pain
- severe infections
- heavy bleeding
- dyspareunia or pain during sexual intercourse
- organ perforation
- urinary problems
- recurrent prolapse
- neuro-muscular problems
- vaginal scarring/shrinkage
- emotional problems.
WHAT TO DO WHEN INJURED BY A TVM?
While the risk of experiencing complications may vary from one woman to another, it does not hurt to be on the alert. Mesh complications may appear very soon after an operation or it may surface years after the mesh was implanted. Regular consultation with the attending physician is highly encouraged.
Should you or anyone you know experience adverse effects which might be related to the vaginal mesh surgery, it is important to get medical attention immediately. Your doctor will be in the best position to determine the best way to address your problem.
The numerous support groups whose members include women injured by these devices will also be more than happy to provide you advice and the needed moral support.
You may then consider other options available to you which include exercising your legal rights to recover losses or damages you may have incurred as a result of the injury. The pain and suffering as well as future medical expenses should be given due consideration. It is vital that you engage the services of an experienced and capable counsel who will look out for your best interest.
SUMMARY OF UPDATES ON TVM LAWSUITS
Observers have noted that transvaginal mesh lawsuits have been proceeding quite satisfactorily over the past year.
Mesh Lawsuits Resolved or Settled
Since July 2012, three cases have already been resolved before a jury, with damages totaling $18.6 million being awarded to the plaintiffs. Two vaginal mesh lawsuits filed in New Jersey and West Virginia have been withdrawn after being settled out of court. Claims of an undisclosed number of injured women have also been reported to be settled by Endo Health Solutions Inc., in behalf of American Medical Systems (AMS), for an estimated amount of $5 4.5 million.
According to a recent report, settlement talks are ongoing between lawyers of plaintiffs and mesh manufacturers named defendants in a multidistrict litigation (MDL) in West Virginia. Except for Ethicon, Inc., all other defendants (Bard, AMS, Boston Scientific, Coloplast, & Cook Medical) are participating in the reported settlement negotiations.
Upcoming Vaginal Mesh Trials
Trials have already been scheduled by Judge Joseph Goodwin of the US District Court for the Southern District of West Virginia involving at least four of the six mesh manufacturers named defendants in a MDL. Hearings have been lined up for December this year and early next year involving Ethicon, AMS, and Boston Scientific. A number of vaginal mesh lawsuits are also expected to be heard during the rest of the year.