An interview with Ann Becker Schutte, Ph.D Last year, for the first time, I attended Stanford...READ MORE
Transvaginal Mesh – Yesterday, Today, Tomorrow?
It’s the early 1800’s. A medical device known as a "womb supporter" is used to treat women with prolapsed uteruses by holding the uterus in place. However, the device causes severe pain to the patient and doctors have difficulty removing the device once implanted, causing more pain and frustration after each failed surgery. In 1933 First Lady Eleanor Roosevelt presents an exhibit, aptly titled "America’s Chamber of Horrors," to the White House, using the "womb supporter" to illustrate the need for protection from dangerous products, foods and medicines.
It’s 1996. Just like the "womb supporters" of the past, mesh is designed to treat pelvic organ prolapse and stress urinary incontinence by implanting the device though incisions in the vagina. Some say that vaginal mesh implants defy the principles of surgery, as mesh implants in the pelvic area are likely to cause problems.
It’s the early 2000’s. Transvaginal mesh implant surgeries increase dramatically – thanks to new packaging that makes it easier for doctors; however, no improvements have been made to improve the safety of the device.
It’s 2013. Transvaginal mesh implants are still on the market. Yet some surgical experts compare the job of removing vaginal mesh implants to removing rebar from concrete – meaning it is near-impossible, often requiring several surgeries to take out the device in bits and pieces, let alone repair the damage done by the mesh device. Use of transvaginal mesh is also associated with signification pain, infection and bleeding.
Why? Have we learned nothing?
You would think that the consumer goods safety initiatives first promoted by powerful woman like Eleanor Roosevelt would have all but eliminated the sale of unsafe products like transvaginal mesh by now. But you’d be wrong.
Transvaginal mesh is, and has been, in the marketplace because of a maze of approvals based on similar predecessor products. Amazingly, the mesh, which has been successfully used to repair hernias for years, was never tested for vaginal repairs. This is because the FDA’s fast-track approval system, the (510k), doesn’t require testing prior to distribution when the product is similar to one already approved.
In 2008, the FDA issued a public health alert, noting the serious complications of transvaginal mesh, but said the complications were rare. Three years later they updated the advisory, saying the occurrences were NOT rare and ordered manufacturers to do post-market safety studies.
A good move at last – but one that came way too late for the thousands of women who now suffer from transvaginal mesh complications.
It’s 2013. It’s time to do what is right and get this product off the market.