FDA to Hold Hearing on the Use of Transvaginal Surgical Mesh and Fast Track Approvals

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.”

We are well-aware of the serious medical consequences women have suffered when the mesh is used for pelvic prolapse and related surgeries. And once implanted, it is often difficult if not impossible to remove the mesh due to the development of scar tissue surrounding the device.

The renowned Mayo Clinic in Rochester, Minnesota and some other major clinics, will simply not perform these procedures using surgical mesh. They prefer to use other very viable ways to correct these issues through the abdomen.

But as reported in the Chicago Tribune, some doctors believe there are patients for whom this is the best alternative where anesthesia use can be a risk factor or for women with recurrence of prolapse. They seem to point to the surgeon’s skill and training as the issue, rather than an inherent problem with the use of mesh in this context.

However, the FDA has had thousands of reports of complications. As injury lawyers who have helped women suffering from some of the excruciating and life-changing results of the use of transvaginal surgical mesh, we urge patients to talk with their doctors about the risks of the use of mesh.

While mesh may be a possible corrective device in other types of surgeries, such as hernia repairs, using this transvaginally may not be a risk that should be taken when the complications can be worse than the original condition. Clinical outcomes have not been shown to be better using surgical mesh — this is something that all patients looking for surgical correction should consider.

As noted in the Chicago Tribune piece, the FDA is looking at various “regulatory options related to mesh, including reassigning products used in vaginal prolapse surgeries to Class III, the most tightly regulated type of device. Should that occur, companies would have to provide much more data about the products’ effectiveness both before and after they come out on the market.”

An FDA public hearing in September is expected to bring out many women who have suffered from the use of this device. The agency will be considering its fast track approval of the use of mesh for this purpose and could reclassify it, making it far more stringent for companies advocating its use in this context.

We urge women to contact our law office to discuss complications from the use of mesh in their surgeries. We will consult with you at no charge.