Articles Posted in Transvaginal Surgical Mesh

Last week, we posted on the recent FDA Obstetrics & Gynecology Devices Panel Advisory Committee hearings that centered on the use of transvaginal surgical mesh to correct Pelvic Organ Prolapse (POP). The second day of the advisory committee hearings focused on the use of surgical mesh for the surgical management of female Stress Urinary Incontinence (SUI), with differing recommendations from those regarding POP.

At the open public hearings, presenters ranged from patients to advocacy groups to clinicians. The presentations themselves also ranged widely from adverse event reporting to a broader review of clinical data.

Surgical mesh manufacturers also presented at the second day of hearings. The industry association AdvaMed advocated on the safety and effectiveness of what are known as suburethral slings to correct SUI. They do not believe that mandatory clinical studies are needed for the products currently being marketed. There are studies underway for products that have new features and they argued that this is sufficient. They also took the position that Class II special controls are adequate.

meeting room Last week, the Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee of the FDA held public hearings the use of transvaginal surgical mesh for the repair of Pelvic Organ Prolapse (POP). As lawyers representing women adversely impacted by vaginal mesh and its use for POP, we want you to know the outcome of the first day of hearings. We will post separately on the second day of hearings that covered the use of vaginal mesh for stress urinary incontinence (SUI).

One the first day of the hearings, the views presented ranged from an outright ban on the use of mesh for this procedure, to the continued use of mesh, despite the adverse events that have occurred with its use. We have posted in recent weeks about these adverse events and complications women have suffered with the use of surgical mesh for these conditions.

The mesh manufacturers presented their point of view essentially stating (in summary) that the benefits of the use of mesh outweighs the complications. This group of presenters supported premarket clinical studies for new mesh products and postmarket studies to evaluate the long-term safety and effectiveness of mesh for POP repair. However, the manufacturers were not supportive of reclassification of the mesh to Class III which would also require premarket approval. One presenter that manufactures a porcine product for POP repair stated that their product does not have the vaginal erosion rates that synthetic surgical mesh has caused.

When we first began writing about problems with transvaginal surgical mesh, it was difficult to find much about it on a Google or Bing search. We were one of the first law firms in the country to represent victims injured by surgical mesh and we continue to remain closely involved in this issue and litigating cases on behalf of our clients.

The Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee will be holding hearings that will be open to the public on the use of surgical mesh in women. The meeting will be held on September 8 and 9, 2011, from 8 a.m. to 6 p.m. in Maryland.

At these hearings, the committee plans to discuss the use of transvaginal surgical mesh and ultimately will make recommendations as to whether it is safe or effective to use this for pelvic organ prolapse repairs in women. We will be attending the hearings.

Earlier this month, we advised our readers that the FDA had issued a safety warning regarding the use of transvaginal surgical mesh in various surgeries for women suffering from conditions such as pelvic organ prolapse. The FDA’s action was the result of thousands of women reporting serious complications with this implantable device.

In a recent article in the Chicago Tribune, that was also published by the LA Times, examples of the complications women have suffered have been reported in great detail. As personal injury lawyers representing women who have suffered from these complications, we are painfully aware of them. There are other ways for surgeons to correct medical conditions such as pelvic prolapse and patients must be very cautious in allowing a surgeon to insert surgical mesh transvaginally.

The recent press on these procedures appears to target the lack of training of some surgeons performing these procedures and using this device. And as is pointed out in the Chicago Tribune piece “the FDA hasn’t required companies selling mesh products to prove they’re safe or effective when used in the pelvis, even though the potential harm can be substantial.”

Nearly a year ago, we posted on the dangers of transvaginal implantation of surgical mesh, including the risks and complications associated with procedures for Pelvic Organ Prolapse or POP and Stress Urinary Incontinence or SUI. After thousands of women have been implanted with the surgical mesh transvaginally, the federal government now says, beware.

Today, in a stunning development, the U.S. Food and Drug Administration issued an update to their prior safety communication that warns both health care providers and patients that the transvaginal surgical mesh procedure used to repair POP could well “expose patients to greater risk than other surgical options” with no evidence that patients’ quality of life will be improved by this procedure.

At the time we warned our readers about this last year, vaginal mesh manufacturers had already reported many complications to the FDA including infection, pain, vaginal epithelium erosion, urinary problems, and the return of conditions for which the procedure was performed. The FDA’s 2008 safety communication was due to adverse events occurring to patients after the transvaginal placement of mesh. The numbers have continued to rise since that time. In our view, the procedure is not worth the potential pain and suffering that patients may endure.