Wednesday, November 21, 2012

An Overview of the FDA Warnings on Urogynecologic Mesh

This article describes the FDA warnings associated with urogynecologic mesh as used in pelvic organ prolapse transvaginal surgical applications, as based on a recently published Current Urology Reports study, An Appraisal of the Food and Drug Administration Warning on Urogynecologic Surgical Mesh, Current Urology Reports (2012, 13:231-239).

Initially surgical mesh was used in the 1950’s to repair hernias via abdominal surgical procedures. Since that time surgical mesh has been used in various applications, with surgeons simply cutting the mesh to the necessary shape to cover the incision. Eventually manufacturers realized how surgeons were using mesh and began meeting the needs by developing mesh products designed specifically for pelvic organ prolapse surgery. Many surgeons who had no formal training in abdominal surgeries nonetheless performed surgeries using vaginal mesh, believing them to be such straightforward procedures that little training was necessary. During the 1970’s, transvaginal mesh surgeries for pelvic organ prolapse were fairly routine and by the 1980’s surgical mesh had realized another application through mesh slings manufactured for the treatment of stress urinary incontinence.

Transvaginal Mesh Receives FDA Approval

While surgeons were already using mesh in the repair of pelvic organ prolapse and stress urinary incontinence it was not until the mid-1990’s that the FDA issued approval for a surgical mesh designed specifically for repair of stress urinary incontinence. Six years later the FDA approved a surgical mesh product designed for repair of pelvic organ prolapse. Of course manufacturers soon realized the potential financial benefits of surgical mesh and began manufacturing “kits” containing pre-shaped surgical mesh for the specific application as well as the required surgical instruments and other specialized tools needed to complete the surgical procedure.

How Transvaginal Mesh Was Approved

Of the more than one hundred surgical mesh kits and devices which have garnered FDA approval for the specific treatment of pelvic organ prolapse only about twenty of those are currently marketed in the United States. All of these mesh devices and kits received FDA approval under a controversial process known as 510(k). So long as the device or drug being presented for approval can be considered substantially equivalent to another product which has already received approval, there will be no requirement of clinical trials or more strenuous guidelines to meet. The article in Current Urology Reports notes that all the mesh devices which are currently being implemented in the use of pelvic organ prolapse and which gained approval under the 510(k) process did so by claiming to be similar to surgical mesh used in hernia repairs—a completely different application and procedure.

Designation of Class II or Class III from FDA

So far as urogynecologic mesh is concerned, there is little to no scientific evidence currently available to show that surgical mesh used in the treatment of POP is either safe for the woman or actually performs better than more traditional surgical procedures. Urogynecologic mesh is currently classified as a Class II device although the FDA is considering changing that status to Class III. Class III devices are considered the most risky to consumers while Class II devices are only believed to have a moderate risk. Heart valves are currently classified as Class III devices and many believe that surgical mesh, when used in transvaginal applications, has sufficient risk to require a Class III classification as well as requiring clinical trials and scientific research.

Public Health Notifications from the FDA

The FDA put out a Public Health Notification in 2008 which detailed the potentially serious complications possible from the use of urogynecologic mesh used in pelvic organ prolapse surgery or stress urinary incontinence surgery. The FDA had received over a thousand reports of adverse events by 2008, received from 2005 forward. A 2011 FDA report stated that “The FDA’s review of these devices has primarily focused on data supporting the adequacy of mechanical performance and material safety…bench and/or animal testing have been used to confirm that engineering specifications are met.” This appears to state that while mesh devices have been reviewed regarding their mechanical performance and that all engineering specifications have been met, there is no indication as to how they actually perform when implanted in a woman’s body in an attempt to correct SUI or POP.

In the 2008 report the FDA concluded that although there were generally better surgical outcomes overall when surgeons implemented surgical mesh in a POP or SUI operation—meaning the surgery could be considered a “success”—the future health risks to women were substantial. Even though the FDA deemed serious complications “rare,” they nonetheless detailed an entire list of fairly serious effects following the surgical procedure. Specific surgical procedures were noted in the discussion of the potential risks of transvaginal surgical mesh such as sacrocolpopexy, vaginal vault suspensions and anterior or posterior transvaginal pelvic organ prolapse repair. While surgical mesh has been used extensively in the form of slings for SUI repair, the FDA notification focused specifically on urogynecologic mesh used transvaginally in pelvic organ prolapse surgeries.

Surgical Procedures and Mesh Types

The article in Current Urology Reports details a variety of surgical techniques which are believed by many to improve the outcome of POP repairs. These include tacking apical and distal mesh to prevent bunching of the mesh and full thickness vaginal wall dissection. While this particular article stated that avoiding a hysterectomy at the same time as the pelvic organ prolapse surgery led to better outcomes, other studies dispute that. Some research appears to show that a hysterectomy done at the same time the pelvic organ prolapse surgery is performed can actually decrease the risk of adverse events and lead to a better overall outcome.

There are several types of mesh on the market today including absorbable mesh, biologic mesh and xenografts although most older meshes have been phased out in favor a polypropylene mesh which is softer, lighter, more flexible, more porous and has a higher level of elasticity. Apparently, the “ideal” mesh implant, according to Chen et al and quoted in the Current Urology Reports article is: “chemically and physically inert, non-carcinogenic, mechanically strong, sterile, not physically modified by body tissues, readily available, inexpensive and have a minimal risk of infection and rejection.”

Adverse Effects of Urogynecologic Mesh Devices

Erosion is the number one complaint of women who have undergone a surgical procedure for pelvic organ prolapse which implemented urogynecologic mesh. The synthetic mesh can literally erode into the bladder, bowel or vagina, leading to serious medical issues. The surgery to remove eroded mesh can also cause more problems for the woman. Pain, infection, bleeding, painful sexual intercourse, organ perforation, urinary problems, neuromuscular issues, vaginal scarring and shrinkage and prolapse recurrence are all additional problems experienced by women who received a urogynecologic mesh implant during pelvic organ prolapse surgery although most women experience multiple adverse symptoms. There have been seven reported deaths associated with pelvic organ prolapse surgery although only three of them could be tied directly to the placement of the surgical mesh. Four more deaths were more closely tied to post-operative complications but were not believed to have a direct tie to surgical mesh. This article discussed the original warnings issued by the FDA regarding surgical mesh used in a urogynecologic application.

Author: Sullo & Sullo Attorneys

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