FDA PELVIC ORGAN PROLAPSE MESH REPORT:
THE REST OF THE STORY
By Sherrie Palm
When the FDA speaks, everyone panics. On July 13, 2011, the FDA released a safety communication on the dangers of transvaginal mesh procedures for treatment of pelvic organ prolapse. The purpose of the FDA is to protect and promote health; they are our watchdog agency. However, what often occurs with reports of this nature is individuals seldom read the entire article and only the yikes factors shouted by the media are grabbed. It is unfortunate that when most women read the FDA article, what they will read is “all mesh is bad”. That is simply not the case. Women truly need to know the “rest of the story”.
All surgical procedures have a risk factor whether utilizing mesh or not. Statistically the surgical complication risk factor of POP mesh repair is considerably lower than with other surgeries. The FDA report states 1503 adverse event reports were filed between 2008 and 2010 with approximately 75,000 transvaginal procedures per year-a ratio of 1%. Risk factor in case reports of hernia mesh repair are approximately 7%, risk factors of complications in breast augmentation surgery are 25%, facelift procedure complications come in at 12%. Realistically for those experiencing surgical complications, the cold stats don’t have nearly as much significance as the pain and dysfunction experienced; there is no doubt that individuals who experience complications from any surgery wish they’d never had the procedure done. We need to clear the air a bit so women considering a surgical procedure to treat pelvic organ prolapse will investigate multiple avenues when considering their treatment choices including mesh procedures that can provide long-term benefit.
The reality of pelvic organ prolapse treatment is quite complex; there are 5 types of POP and it’s possible to have any combination of these types. According to an AUGS article (American Urogynecologic Society), research provided by Dr. Jennifer Wu indicated that 28.1 million women in the US alone will have pelvic floor disorders in 2010; 3.3 million of them are women with pelvic organ prolapse. This is a global women’s health pandemic; with vaginal childbirth and menopause as the 2 leading causes, POP encompasses the largest demographic of any women’s health issue.
There are multiple POP treatments available, both surgical and non-surgical. Surgically the choices are numerous and will vary by the type of POP that needs to be addressed as well as the preference of the physician performing the surgery. Our bodies are very individual in how they react to surgical procedures; each woman's scenario is unique. It is important that women do their homework. We position ourselves ahead of the curve by consulting with a female pelvic medicine reconstructive surgeon (a FPMRS may be a urogynecologist or urologist), specialists trained in the intricacies of the female pelvic structure. Most difficulties that have occurred in the past were related to surgeons who were not specialists in the field of pelvic organ prolapse attempting these complex procedures which should be left to the specialists. Improper technique utilized in placement and attachment of mesh truly muddies the waters and leads to complications such as those addressed in the FDA article.
Typically, women in an earlier stage of prolapse will consider treatment options prior to jumping to the surgical page but for women in more advanced stages of POP, surgery is most often the treatment of choice. It was for me. Surgical treatment for 3 types of POP at an advanced stage meant I had to consider and discuss mesh placement. I felt the mesh procedures my urogynecologist wanted to proceed with were the best choice for my health needs; we discussed it in great detail. I’m extremely active; I felt my risk factor for additional surgery was reduced by utilizing a synthetic product that was stronger than my own menopausal tissues. As a woman in her mid 50’s, I wanted my POP repair to be a one-time event. I did my homework and made sure I not only found a urogynecologist, I also did a background check to make sure her reputation was good and asked a ton of questions prior to surgery.
As is typical with health scares, there are multiple layers to consider. As a women's pelvic floor health advocate who guides women regarding POP treatment and surgery on a daily basis, I feel it is vital that we give women ALL available information. It puts women at a disadvantage when they only get one side of the story regarding any health concern. No mesh may mean additional surgery in your future; when discussing your surgical choices for a POP procedure, make sure to discuss both sides of the coin for mesh use vs. the potential for additional surgery down the road if mesh is not utilized. Like most health procedures that get a bad rap, mesh use for pelvic organ prolapse surgery should be carefully analyzed from many angles b/4 being dismissed. New procedures are developed for POP repair every year; currently transvaginal (through the vagina), laparoscopic, robotic, abdominal, or a combination of techniques of surgery are all options for POP repairs including use of mesh.
Ideally treatment of POP truly should be a partnership between multiple clinician sectors with primary care physicians and gynecologists screening and diagnosing pelvic organ prolapse, physical therapists, occupational therapists, biofeedback therapists, and myofascial release therapists, and other treatment therapists providing non-surgical treatment options, and FPMRS urogynecologists or urologists providing both surgical and non-surgical guidance and treatments. There are approximately 1800 urogynecologists/urologists in practice with additional physicians currently undergoing FPMRS training. To find a specialist in your area, access one of several links on APOPS website Practitioner Locator page.
It is up to each of us along with our clinicians to determine which treatment types suits us best; it's not as simple as whether surgery or non-surgical treatments are the best option or even whether or not mesh should be utilized. What it boils down to is choosing the best path for you as an individual-exploring all options prior to making a treatment/surgical decision is vital. We all need to be our own best health advocates and then share what we learn with others.
Every Voice Matters!
Updated September 2016