Coloplast develops and manufactures medical devices and services for "intimate healthcare needs." (You can learn more about the company on its website.)
Dr. Angel Marie Johnson, the director of our Women's Health Center in Dedham, uses certain Coloplast products in her urogynecology practice. Below, she answers some common questions about these devices.
What Coloplast products do you use in your practice? What conditions do these devices treat?DR. JOHNSON: One of the devices I use is the Coloplast Altis Single Incision Sling. This sling is incredibly effective at reducing the leakage of urine with activity (think sneezing, coughing, jumping), otherwise known as stress urinary incontinence (SUI).
It's my "go to" sling, although I don't place it in everyone. It's a very reliable, predictable, and effective device and is safe for the treatment of stress urinary incontinence in women.
The other product I use from Coloplast is Restorelle® Y, which is an ultra-lightweight mesh that I use in surgery for apical prolapse, or when the top of the vagina or uterus has started to come down and lose support. What I do is attach the mesh to the vagina and or cervix abdominally to re-support it. This surgery is called a sacrocolpopexy, and I perform it laparoscopically, abdominally, or robotically—never vaginally.
There's been a lot of debate in the media about mesh. Discuss the safety of the mesh you use: Altis Single Incision Sling and Restorelle® Y.DR. JOHNSON: All the mesh produced by Coloplast is monofilament polypropylene mesh. This mesh is expertly designed to minimize infection, inflammation, and pain. In my experience with this material, incidence of infection has been very low, and the risk of mesh complications, including exposure, is also very low.
The mesh is also ultra-lightweight, which is significant as well. Whenever you place an implant inside the human body, you want to make sure the body's going to heal around it appropriately. If a device is too heavy, too rigid, and/or too inflexible, instead of the body incorporating it and almost recognizing it as itself, the body will wall it off or scar it over. In a place like the vagina, that becomes a problem because it can result in pain and bleeding.
By using ultra-lightweight monofilament polypropylene mesh produced by Coloplast, and other companies alike, it helps not only incorporate the tissue more appropriately, but it helps minimize infection rates, while providing a stronger, more durable, long-standing repair with less discomfort.
Is there anything else patients should be aware of regarding surgical mesh?DR. JOHNSON: Many of my patients mention "something" about "the FDA and mesh." Here are the facts, according to the FDA website:
"On April 16, 2019, the FDA ordered the two manufacturers of the three mesh surgical products on the market for the transvaginal repair of pelvic organ prolapse in the anterior/apical compartment (cystocele) to stop selling and distributing their products immediately."
The keywords here are "transvaginal repair"—this type of surgery is where synthetic mesh is placed through the vagina.
When I perform a sacrocolpopexy with Coloplast's Restorelle® Y, I perform the procedure thru the abdomen —never vaginally.
This is an important distinction. Material placed differently will function differently and is associated with different effects and complications.
Also important: the American College of Obstetricians and Gynecologists (ACOG) issued a Practice Advisory following the FDA's order: "It is important to note that the FDA announcement applies only to mesh placed vaginally to treat POP [pelvic organ prolapse]. The FDA order does NOT apply to transvaginal mesh for stress urinary incontinence. Additionally, the FDA order does not apply to mesh placed abdominally (sacrocolpopexy via laparotomy or endoscopy) for prolapse repair."
The American Urogynecologic Society and the Society of Gynecologic Surgeons endorsed this Practice Advisory.
What if someone doesn't want mesh? Are there any other options?DR. JOHNSON: Coloplast also produces biologic grafts, which are made from human and animal tissue. For the treatment of stress urinary incontinence, the traditional treatment is using a synthetic mesh sling. But for patients who have had a sling before or have had problems with mesh, I will use cadaveric fascia lata and use it in a similar way I would the synthetic mesh.
Thanks, Dr. Johnson!
If you're suffering from stress urinary incontinence or pelvic organ prolapse, consider making an appointment with Dr. Johnson soon.