Sunday, February 12, 2012

Transvaginal Mesh: Is an FDA Recall on the Horizon?

Even though some consumer advocate groups—such as Public Citizen—have called for the FDA to ban the marketing of transvaginal mesh for use in surgeries such as the repair of pelvic organ prolapse and stress urinary incontinence as yet there has been no definitive conclusions reached as to whether the use of mesh should be permanently discontinued. The FDA has made physicians and the public aware of the potential risks involved in using transvaginal mesh including erosion, contraction or shrinkage of the mesh once it has been implanted, however now must decide whether further action is called for in light of the flurry of lawsuits regarding mesh complications.

It is highly unlikely that the manufacturers of the mesh will issue a voluntary recall, although the FDA may choose to elevate the approval process for the mesh from the moderate risk Class II to the higher-risk Class III. If the mesh device class is reclassified, manufacturers will face a much tougher process when gaining FDA approval and will also be required to conduct human trials. A Class III is the highest risk category for medical devices however the FDA could conceivably bump up the existing class level without recalling existing devices. Finally, the FDA could issue sterner warnings regarding the mesh devices to both physicians and patients while allowing the device to keep the same approval process, meaning that new mesh products which are substantially equivalent to already-approved ones would be granted approval.

FDA Safety Recommendations

Currently the FDA has issued safety recommendations and warnings regarding the use of transvaginal mesh implants including:

Patients who have pelvic organ prolapse surgery using mesh may be subject to complications which are not experienced by those undergoing more traditional forms of POP surgery without mesh.

Placement of the transvaginal mesh patch may be life-altering for some women, and the chronic levels of pain can sometimes continue even after the mesh is surgically removed.

Mesh-associated complications are not rare—approximately ten percent of women who undergo pelvic organ prolapse surgery with mesh experienced some level of erosion within the first year following the surgery.

Erosion is the most common complication, and of the women who experienced erosion of the mesh into the vaginal wall or other organs, more than half required surgical excision of the mesh with some requiring multiple surgeries.

Many women have reported mesh contraction which results in chronic vaginal pain or vaginal shortening.

When mesh is used in stress urinary incontinence surgeries recurrence of the SUI is more common than in traditional repair which doesn’t use mesh.

When mesh is used to perform a pelvic organ prolapse surgery abdominally, it appears to have lower rates of complications as compared to transvaginal surgery with mesh.

As far as effectiveness, the FDA states that transvaginal repair with mesh does not appear to provide any added benefits compared to more traditional surgeries without mesh.

The FDA goes on to state, however that so far the adverse events which resulted from transvaginal mesh surgeries were both inconsistently defined and reported, that very few of the existing studies extended longer than two years, and that the studies which exist tend to be poorly designed, poorly conducted and fail to account for variable patient follow-up length. The results from the few studies which exist reflect both primary and repeat prolapse repairs which could skewer the overall results.

FDA Recommendations for Women Considering POP Mesh Surgery

The FDA recommends that women who are considering pelvic organ prolapse surgery using mesh should be fully aware of the potential risks and complications of mesh implants. Women should also know that having a surgery using mesh could potentially increase the risk for additional surgeries should there be mesh-related complications, and in some patients additional surgeries fail to resolve the pain or other medical issues. Ask your doctor about alternatives to mesh surgery, and if you decide transvaginal mesh surgery is right for you, make sure your surgeon has extensive experience in performing the procedure.

If you’ve already undergone POP surgery using mesh, you must notify your healthcare provider if you have any complications or symptoms such as persistent pain, infection, or persistent bleeding. If you believe you have suffered harm from the use of a mesh device, it’s important that you seek knowledgeable counsel regarding your rights and your potential for filing a lawsuit against the manufacturer of the device.

Author: Sullo & Sullo Attorneys

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