Mpathy Medical (Raynham, Massachusetts) has launched its newest version of a surgical mesh for pelvic organ prolapse (POP) repair, this time specifically designed for laparoscopic sacrocolpopexy procedures.
It's estimated that about half of women aged 50 to 70 experience POP — when one or more organs (uterus, vagina, urethra or bladder) shift downward and bulge into or out of the vaginal canal. Childbirth, aging, menopause and obesity are the culprits behind this often painful condition, which can have a variety of complications.
Urinary incontinence is just one of those resulting complications and the National Women's Health Resource Center (Red Bank, New Jersey) estimates that $20 billion is spent on associated treatment annually for that problem alone, while surgeries to correct POP cost more than $1 billion annually for those 65 and older in the U.S.
If non-surgical therapies fail, urogynecologists must surgically hoist up the organs. It's done in several ways, although the most popular approach is now done laparoscopically, with placement of a mesh that suspends the organs.
Hence, Mpathy's launch of Restorelle Y for enhanced laparoscopic sacrocolpopexy procedures to treat POP, a new version of the company's Restorelle launched in May following FDA 510(k) clearance earlier in the year.
This mesh is a lighter-weight version than previous meshes that urogynecologists originally adapted from hernia repair surgeries. Seven other companies have launched similar meshes, but Mpathy says it is the lightest.
"Restorelle Y is made of polypropylene, which is quite normal for meshes," Mpathy CEO Ian Stevens told Medical Device Daily. "But the weight of Restorelle is just 19 grams per square meter. Most other meshes are in the 30 grams-per-square-meter range. It's basically a grid with lots of space between threads. The micropores amongst the woven threads are much smaller [than competitive products] and designed to be a size so that fibroblasts can settle in the holes and allow tissue to grow."
Restorelle Y is based on the company's Smartmesh Technology, which was designed by Mypathy's surgeon founder specifically for the female anatomy and physiology. Using an ultrasonically welded Y-shaped graft, the Restorelle Y procedure can be performed using an abdominal, laparoscopic or robotic approach.
The low profile of the device not only leaves less mesh behind in the patient's body, but also enables easy passage through narrow laparoscopic ports.
These lightweight and conforming attributes of Restorelle Y will be key to the mesh's success, particularly in light of a recent FDA warning regarding the use of mesh in incontinence and prolapse surgeries. The agency cited 1,000 incidents reported over the last three years, a period during which an estimated 800,000 procedures were performed, representing an event rate of just over 0.1%.
"The most frequent complications included erosion through vaginal epithelium, infection, pain, urinary problems, and recurrence of prolapse and/or incontinence," according to the FDA notice. "There were also reports of bowel, bladder and blood vessel perforation during insertion. In some cases, vaginal scarring and mesh erosion led to a significant decrease in patient quality of life due to discomfort and pain, including dyspareunia.
"Specific characteristics of patients at increased risk for complications have not been determined. Contributing factors may include the overall health of the patient, the mesh material, the size and shape of the mesh, the surgical technique used, concomitant procedures undertaken (e.g. hysterectomy), and possibly estrogen status," the report warns.
FDA advises physicians to use the mesh only if they have specialized training, to be vigilant about watching for complications and to make sure patients know about the potential complications. The agency provided no solutions to avoid the problems.
Surgeons may be unlikely to discontinue use of mesh. At a recent meeting of surgeons at the 37th Global Congress of Minimally Invasive Gynecology, a session focused on the topic revealed that 90% of the attendees use mesh in these procedures. Most thought the benefits outweigh the potential complications, particularly in light of the fact that new products are more specifically engineered for female pelvic use, rather than old-style meshes adapted from hernia repair applications (MDD, Nov. 4, 2008).
"The main risk when using mesh is that you introduce a foreign material into the body," Stevens said. "The material can be rejected and you get erosions where the mesh protrudes through the incision. If the mesh isn't pliable, you might get folding and bunching and then that can cause irritation or new tissue doesn't grow through it.
"Having to excise a mesh that was implanted is a much worse procedure than the original implantation," he said. "Our mesh is also hydrophilic, which means that when it comes into contact with tissue, it contours nicely to the tissue and has low memory and is not likely to bunch up."
Mpathy is a headquartered in Glasgow, Scotland, and manufactures Restorelle at a facility there, but has a small marketing team and subsidiary company in the U.S.
"We have the CE mark, but we launched in May in the U.S. and we're really not focused in Europe at all, just on the world's biggest healthcare market," Stevens said, adding that Restorelle Y is priced in a range of $800 to $1,000.
Other companies with products in this space include Ethicon Women's Health and Urology (Sommerville, New Jersey), American Medical Systems (Minnetonka, Minnesota), Caldera Medical (Agoura Hills, California), Boston Scientific (Natick, Massachusetts), Coloplast (Minneapolis), C.R. Bard (Murray Hill, New Jersey) and Tri-anim (Sylmar, California).