September 13, 2019
The FDA and Mesh Slings: What's Going On?
If you watch any amount of daytime television, it is almost guaranteed that you’ve seen class-action lawsuit advertisements against mesh sling manufacturers. Unless you, yourself, or a loved one (not purposely trying to sound like the commercial) have experienced problems with pelvic mesh surgery, you probably don’t know what all the fuss is about. We’ll go over what exactly pelvic sling surgery is and the various types of the procedure, what the possible side-effects are of the surgery, and what the Food and Drug Administration (FDA) is doing to ensure public safety and health.
So what is pelvic sling surgery, and why would someone get it? Pelvic sling surgeries are often performed on women that are suffering from light bladder leaks with the development of Stress Urinary Incontinence or SUI. These leaks are caused by the weakening of the pelvic floor muscles. To correct and support these weakened muscles, women may choose one of two kinds of pelvic sling surgeries. The first is called traditional sling surgery. This procedure consists of the doctor taking organic tissue from the patient's stomach or thigh to create a sling to support the urethra and bladder. Small incisions are made in the vagina and stomach to have the sling inserted and stitched to the inside of the stomach wall. In some cases, the sling can be made from a donor's tissue. The second kind is called mid-urethral sling surgery. This is when a thin strip of synthetic mesh is used to make the sling and is surgically placed under the urethra by one of three methods. Retropubic method: A small cut is made under the urethra, in addition to two cuts being made above the pubic bone. A needle is used to put a sling under the urethra behind the pubic bone to support the bladder and urethra. Transobturator method: A cut is made under the urethra and on each side of the labia. The sling is then placed under the urethra. Single-incision mini method: A single cut is made in the vagina and the sling is put through it. Ideally, after the surgery and recovery time women should experience a reduction in leaks. Unfortunately, there are some possible side-effects that can come about during or post-procedure.
Naturally, any sort of medical procedure that involves incisions and stitches is going to have some level of discomfort. But women that have received the pelvic sling surgery, specifically the synthetic mesh sling, have reported certain side effects. Chronic Pain - Pain post-procedure is normal, however, if the pain does not subside weeks after healing, there could be more going on. Pain during intercourse - Some women reported pain during sexual intercourse, according to this article from UCLA. Exposed Mesh - Reports of the mesh migrating after surgery and being exposed through the vaginal opening has also occurred. Vaginal mesh erosion - Mesh can break down or wear away over time which may cause pain or discomfort. This is the most common side-effect reported. Infection - Especially with the use of synthetic mesh, infections can occur. This can be internal or at the incision sites. The after-effects of infection can warrant medication or topical ointments, further adding to costs. Injuries - Injury to the bowel, bladder, nerves, or blood vessels can occur during surgery. This is a risk that is taken with all surgeries! Further Urinary Complications - Some women may experience complications with urinating after surgery, while others may start to experience urge incontinence. Bleeding - some women experience vaginal bleeding from their surgery, even months after healing. This can vary from light spotting to heavy bleeding. With reports of these complications becoming more frequent, the FDA stepped in to protect public health.
Whenever you search for pelvic sling surgery on the Food and Drug Administration’s website, this box is at the top before readers can move onto more information. On April 16, 2019, the FDA ordered all manufacturers of surgical mesh intended for transvaginal repair of anterior compartment prolapse (cystocele) to stop selling and distributing their products immediately. The FDA has determined that the manufacturers, Boston Scientific and Coloplast, have not demonstrated reasonable assurance of safety and effectiveness for these devices, which is the premarket standard that now applies to them since the agency reclassified them into class III (high risk) in 2016. Since the FDA has not received sufficient evidence to assure that the probable benefits of these devices outweigh their probable risks, the agency has concluded that these products do not have reasonable assurance of safety and effectiveness. The companies will have 10 days to submit their plans to withdraw these products from the market. Women who have received transvaginal mesh for the surgical repair of pelvic organ prolapse should continue with their annual and other routine check-ups and follow-up care. There is no need to take additional action if you are satisfied with your surgery and are not having any complications or symptoms. You should notify your health care provider if you have complications or symptoms, including persistent vaginal bleeding or discharge, pelvic or groin pain, or pain with sex. You should also let your health care provider know if you have surgical mesh, especially if you plan to have another surgery or other medical procedures. If you were planning to have mesh placed transvaginally for the repair of pelvic organ prolapse, you should discuss other treatment options with your doctor. If you have had pelvic organ prolapse surgery but do not know whether your surgeon used mesh, ask your surgeon at your next scheduled visit. In short - the FDA felt that pelvic mesh benefits did not outweigh the risks and manufacturers were not taking the proper steps to ensure patients' safety, so sale and distribution has been stopped.
What is Pelvic Sling Surgery?
So what is pelvic sling surgery, and why would someone get it? Pelvic sling surgeries are often performed on women that are suffering from light bladder leaks with the development of Stress Urinary Incontinence or SUI. These leaks are caused by the weakening of the pelvic floor muscles. To correct and support these weakened muscles, women may choose one of two kinds of pelvic sling surgeries. The first is called traditional sling surgery. This procedure consists of the doctor taking organic tissue from the patient's stomach or thigh to create a sling to support the urethra and bladder. Small incisions are made in the vagina and stomach to have the sling inserted and stitched to the inside of the stomach wall. In some cases, the sling can be made from a donor's tissue. The second kind is called mid-urethral sling surgery. This is when a thin strip of synthetic mesh is used to make the sling and is surgically placed under the urethra by one of three methods. Retropubic method: A small cut is made under the urethra, in addition to two cuts being made above the pubic bone. A needle is used to put a sling under the urethra behind the pubic bone to support the bladder and urethra. Transobturator method: A cut is made under the urethra and on each side of the labia. The sling is then placed under the urethra. Single-incision mini method: A single cut is made in the vagina and the sling is put through it. Ideally, after the surgery and recovery time women should experience a reduction in leaks. Unfortunately, there are some possible side-effects that can come about during or post-procedure.
What Are the Side Effects?
Naturally, any sort of medical procedure that involves incisions and stitches is going to have some level of discomfort. But women that have received the pelvic sling surgery, specifically the synthetic mesh sling, have reported certain side effects. Chronic Pain - Pain post-procedure is normal, however, if the pain does not subside weeks after healing, there could be more going on. Pain during intercourse - Some women reported pain during sexual intercourse, according to this article from UCLA. Exposed Mesh - Reports of the mesh migrating after surgery and being exposed through the vaginal opening has also occurred. Vaginal mesh erosion - Mesh can break down or wear away over time which may cause pain or discomfort. This is the most common side-effect reported. Infection - Especially with the use of synthetic mesh, infections can occur. This can be internal or at the incision sites. The after-effects of infection can warrant medication or topical ointments, further adding to costs. Injuries - Injury to the bowel, bladder, nerves, or blood vessels can occur during surgery. This is a risk that is taken with all surgeries! Further Urinary Complications - Some women may experience complications with urinating after surgery, while others may start to experience urge incontinence. Bleeding - some women experience vaginal bleeding from their surgery, even months after healing. This can vary from light spotting to heavy bleeding. With reports of these complications becoming more frequent, the FDA stepped in to protect public health.
What the FDA is Doing
Whenever you search for pelvic sling surgery on the Food and Drug Administration’s website, this box is at the top before readers can move onto more information. On April 16, 2019, the FDA ordered all manufacturers of surgical mesh intended for transvaginal repair of anterior compartment prolapse (cystocele) to stop selling and distributing their products immediately. The FDA has determined that the manufacturers, Boston Scientific and Coloplast, have not demonstrated reasonable assurance of safety and effectiveness for these devices, which is the premarket standard that now applies to them since the agency reclassified them into class III (high risk) in 2016. Since the FDA has not received sufficient evidence to assure that the probable benefits of these devices outweigh their probable risks, the agency has concluded that these products do not have reasonable assurance of safety and effectiveness. The companies will have 10 days to submit their plans to withdraw these products from the market. Women who have received transvaginal mesh for the surgical repair of pelvic organ prolapse should continue with their annual and other routine check-ups and follow-up care. There is no need to take additional action if you are satisfied with your surgery and are not having any complications or symptoms. You should notify your health care provider if you have complications or symptoms, including persistent vaginal bleeding or discharge, pelvic or groin pain, or pain with sex. You should also let your health care provider know if you have surgical mesh, especially if you plan to have another surgery or other medical procedures. If you were planning to have mesh placed transvaginally for the repair of pelvic organ prolapse, you should discuss other treatment options with your doctor. If you have had pelvic organ prolapse surgery but do not know whether your surgeon used mesh, ask your surgeon at your next scheduled visit. In short - the FDA felt that pelvic mesh benefits did not outweigh the risks and manufacturers were not taking the proper steps to ensure patients' safety, so sale and distribution has been stopped.