FDA to Women: Transvaginal Surgical Mesh Can Cause Serious Complications

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.

Today’s new safety communication does not surprise us. As injury lawyers representing women implanted with surgical mesh, we represent women who have had this procedure and are suffering from the consequences.

Some women have scar tissue that is so painful that cannot sit down without pain. Some women have chronic pain. Some women have suffered a severe blow to their quality of life, including their sexual, urinary and other functions. All of them should question why the federal government did not take this step sooner. We can only assume that a recall could well be issued in the future.

There is another way to correct POP that does not carry the risks associated with the surgical mesh implanted transvaginally. This method makes the repairs by going through the abdomen and using stitches. The FDA has now made it clear that there is “no evidence” that mesh provides “any greater clinical benefit than non-mesh surgeries.”

Because the transvaginal correction carries risks, the FDA is now ” ‘asking surgeons to carefully consider all other treatment options and to make sure that their patients are fully informed of potential complications from surgical mesh. Mesh is a permanent implant — complete removal may not be possible and may not result in complete resolution of complications.’ ”

And as we have noted, the complications from this procedure can be life-changing and severe. Once implanted, it can be very difficult to correct the problems that result from the implantation of the mesh, including removal of scar tissue as well as removal of the mesh.

The FDA recommendations for patients are:

1. Know the options and make sure that you understand why the surgeon is recommending the mesh procedure.

2. Get routine check ups and surgical follow-ups. Tell your doctor if you are having any abnormal bleeding, pain or other symptoms.

3. If you have had POP surgery, ask your surgeon whether mesh was used.

Outside experts will meet in early September to consider the use surgical mesh in the treatment of POP, as well as the risks of the transvaginal repair and the need for clinical studies.

Hersh & Hersh is a California consumer law firm that is dedicated to helping those injured by defective medical devices throughout the country. We are injury lawyers with decades of experience and expertise representing women harmed by defective medical devices, implantations and dangerous drugs. We have litigated landmark legal cases involving the protection of women and their health. We have been at the forefront of protecting women harmed by medical devices and drugs, including silicone breast implants, DES, IUD’s and others.

If you or someone you know has had a transvaginal surgical mesh procedure and is experiencing complications, please contact our law offices immediately for a free consultation with regard to your medical and legal options.