Yesterday, April 16, 2019, the FDA announced an order for Boston Scientific and Coloplast to stop selling pelvic mesh.
These products were designed to help women with pelvic support disorders such as uterine prolapse or cystocele. They were initially approved for use in 2002 and in 2016 were placed in a special category requiring additional proof of their effectiveness and safety.
We are providing a link to the FDA statement and also making this announcement to ease our patients concerns about these mesh products.
Here at the Women’s Health Group, Dr. Cindy Long and myself, Dr. Steve Volin perform hundreds of surgical procedures using surgically implanted mesh for the treatment of pelvic organ prolapse and urinary incontinence every year. We have treated several thousand patients successfully over the years with these conditions and are experts in the evaluation and treatment of prolapse and incontinence.
Dr. Steve Volin and Dr. Cindy Long
The products we use for these treatments are products with several decades of use, are state of the art and the best products on the market. We predominantly use Alyte and Advantage mesh products when we use mesh for incontinence and support. These products are not under investigation and they are not the products being withdrawn from the market. We have not been using vaginally placed pelvic mesh in our practice since 2009.
If you are a patient in our practice who has had pelvic support or incontinence surgery since 2009, we can assure you that none of the products currently being recalled have been used in your surgery and that our patients have only had surgery with the most up to date mesh products which are still the gold standard in gynecologic surgery. This order and recall does not affect you.
Of course, if you ever have issues related to complications after surgery, always reach out. We are here for you. Please feel free to contact our office if you have any questions or concerns.
Warm Regards and Wellness,
Steve Volin, M.D.