Tuesday, March 6, 2012

Transvaginal Mesh: Are There Safer Alternatives?

In light of the recent lawsuits filed against manufacturers of transvaginal mesh implants, many are wondering whether a safer alternative to using the potentially risky mesh exists. Mesh has been used since the 1950’s, primarily for hernia surgeries which are performed abdominally. Surgeons began expanding the use of the mesh to include surgeries on women for pelvic organ prolapse or stress incontinence. Women who had given birth multiple times, undergone a hysterectomy or were in menopause often experienced difficulties when their internal organs prolapsed as a result of the overstretched muscles and ligaments. The mesh once used solely for hernia repair was now being simply cut to a different size or shape and used in these POP and SUI surgeries, where surgeons fashioned the mesh into a support for the prolapsed organ. As time passed, the surrounding tissues would grow into the mesh, creating a permanent solution to keeping the organs in their place.

Complications from Transvaginal Mesh

After decades of using the mesh in transvaginal applications, complications from the mesh began surfacing. After carefully reviewing adverse event reports as well as the handful of studies done on the safety of the mesh implants the FDA issued a safety warning in 2008 declaring that complications from the mesh implants were not as rare as once believed. In the past several years over 4,000 women have reported complications from the mesh, primarily a particularly serious issue known as erosion when the mesh works its way through the vaginal wall and even into other surrounding organs. Other complications include infection, chronic urinary tract infections and pain, ranging from moderate to chronic and severe.

Is There a Safer Alternative?

A wide range of research has been done regarding the benefits of one type of surgery over the other, with most results indicating that the use of mesh implants in POP or SUI surgeries is not superior to more traditional methods. Similarly, an FDA review of the scientific literature regarding vaginal mesh use in surgeries taking place between 1996 and 2011 found that transvaginal repair with mesh improves neither the end result nor the quality of life when compared to traditional, non-mesh repairs. One study, published in The New England Journal of Medicine found that the mesh approach rendered more effective relief of symptoms, however noted a higher incidence of subsequent complications from the mesh surgeries. Over 300,000 POP and SUI surgeries are performed each year in the United States, however many of the women undergoing these surgeries are not fully informed of the alternatives to mesh surgery as well as the possible complications.

History of Pelvic Organ Prolapse Surgery

For over five decades surgeons have been performing a procedure to repair pelvic organ prolapse which includes an abdominal incision and using the woman’s own tissues to tack up and hold the dropping pelvic organs where they should be. This procedure generally required a hospital stay of several days as well as a recovery time which could be as long as several months. Later, a device known as a laparoscope was used in POP surgeries. The laparoscope is a length of tube with a camera on one end. When it is placed inside the body, the laparoscope allows the surgeon to repair the damage without making large incisions in the abdomen. When using this device the scope and instruments are inserted through small holes in the body, the procedure is outpatient and recovery time is about two weeks. Using mesh in the surgeries can be done either through an abdominal incision or vaginal incision although the failure rates tend to be higher in those procedures done vaginally.

Comparing Traditional Surgery to Mesh

One study contrasted traditional prolapse surgery with mesh surgery in nearly 400 women; over half of the women were chosen for surgery using the mesh implant while the other women underwent more traditional surgery methods. The outcome of the study indicated that while there were better outcomes with respect to prolapse symptoms when the mesh was used, there were significant complications from the mesh both during the surgery and later. One surgeon noted that although the new transvaginal mesh surgery offered clear advantages over traditional surgery methods, the risk of complications from mesh made it imperative that the patient be fully informed and that all pros and cons be carefully weighed.

The Burch Procedure

A procedure known as the Burch procedure has been found to be a safer surgical alternative to transvaginal mesh implants in the treatment of stress urinary incontinence. This procedure uses the more traditional method of suturing the ligaments surrounding the bladder to hold up the tissues beside the urethra and can be done via an incision in the abdomen, laparoscopically or vaginally, and although the Burch procedure does not appear to be more effective than mesh, it may alleviate the safety concerns of using mesh implants.

The FDA will soon make their decision about whether the mesh devices need to be subjected to more stringent rules and regulations however in the meantime the lawsuits continue to stack up.

Author: Sullo & Sullo Attorneys

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