Coloplast’s Novasilk Mesh and Mentor-Line of Slings Carry New Warnings

Transvaginal mesh or slings are common devices used to help women cope with pelvic organ prolapse and stress urinary incontinence. One of the more popular devices is the Novasilk mesh, manufactured by Coloplast. The Novasilk mesh is a transvaginal mesh used to help correct pelvic organ prolapse by reinforcing the weakened tissue and stabilizing the vaginal wall. Introduced to the market in 2005, Novasilk was not required to undergo testing based on its similarity to an already approved device by the FDA. Novasilk is a synthetic mesh made of polypropylene, a lightweight material that is less stiff than previous mesh designs. Similar to other mesh products, this product also does not come without the dangerous risks of erosion and exposure.

Coloplast also manufactures vaginal slings for stress urinary incontinence. The three types of Coloplast slings are; transobturator, suprapubic, pubovaginal. The transobturator and the suprapubic, also known as fixationless slings, are made from a synthetic material and provide support by cradling the urethra and bladder neck. These types of slings are held in place with the patients’ natural tissue rather than with screws or sutures. Coloplast fixationless slings are the Aris and Supris. And there are risks associated with these products as well, including erosion and the need for excision. The last type of sling known a pubovaginal helps a woman retain bladder control. The Colopoast Suspend Fascia Lata and Axis Dermis, use cadaver skin to help suspend the urethra and bladder neck.

What is particularly worrisome about these products is that, while removal may become necessary due to infection or erosion, complete removal may not be an option and a patient could then be left to deal with the painful side effects of these devices for the rest of their lives.

In July 2011, an FDA update was issued for all transvaginal devices to warn doctors and patients that serious complications are not rare and that having these devices placed could expose patients to a greater health risk.

And more recently, on January 3, 2012, an FDA requirement was released to all transvaginal device manufactures, which will require manufactures to present study plans to the FDA addressing detailed safety and effectiveness concerns. For many patients already implanted with these devices, it is too little, too late, to only now begin re-evaluating their studies in order to find the degree of risk associated with the multitude of complications that are associated with transvaginal devices.

If you or someone you know has suffered serious complications and additional surgery as a result of a transvaginal mesh or sling medical device, please contact Pogust Braslow & Millrood. Just fill out this form, click here to send us an email or call us at (610) 941-4204.