Despite FDA warnings that a synthetic mesh used to treat a weakening of the female pelvis's walls can cause infection, pain, and disease recurrence, surgeons are increasing their use of the device. What's more, when compared to not using mesh, younger patients who undergo surgery with mesh for pelvic organ prolapse (POP) are more likely to have a repeat surgery the following year, and older patients are more likely to have complications while they're in the hospital, according to new research from Weill Cornell Medical College.
POP occurs when a woman's uterus or vaginal walls weaken and descend, causing bleeding, incontinence and other painful symptoms. The condition affects about 40 percent of women after childbirth, according to a 2002 study in the American Journal of Obstetrics and Gynecology.
Using data from the New York State Department of Health Statewide Planning and Research Cooperative System (SPARCS), which records every incidence of surgery in the state, the researchers found that POP repair using mesh increased from 21 percent in 2008 to 30 percent in 2011, despite multiple FDA warnings beginning in 2008.
The researchers broke the patients into two age groups, discovering that younger patients who received mesh had a 66 percent higher risk of experiencing another intervention within one year when compared to those who had repair without mesh. Mesh use was associated with 36 percent higher risk of developing in-hospital complications such as urinary retention among older patients. The study was published June 2 in BMJ.
Dr. Bilal Chughtai. Photo credit: Weill Cornell Art and Photography
"This study is addressing the real-world, population-based application of mesh as a medical device, and it yields a different profile for its safety — that mesh is not as safe as people believe it is," said senior author Dr. Art Sedrakyan, an associate professor of healthcare policy and research at Weill Cornell.
Mesh is frequently used for POP because it's relatively inexpensive and provides an easier solution for physicians than the alternative, such as more time-consuming and skillful repair of damaged tissue. Previous research investigated the safety and efficacy of mesh, but the studies were small and yielded conflicting results, the authors say.
This study is the first to investigate mesh use in POP surgeries on a major population level like New York State and to employ such an extensive data set. The large number of surgeries allowed the researchers to evaluate safety by different age groups. The researchers also used propensity matching, an advanced statistical technique that ensures that the patient groups being examined are truly comparable and therefore yield reliable results.
Importantly, the researchers emphasize that mesh is not always dangerous and caution against extreme interpretation of the findings. In some instances mesh use might be needed and women should discuss with their physicians which form of POP surgery would be most effective for them personally, taking into account benefits and harms as well as factors such as anatomy, age and medical history.
The researchers' ability to glean insights based on age, a patient-specific characteristic, highlights the need for and the potential of a comprehensive registry of mesh-based surgical procedures and their outcomes, added lead author Dr. Bilal Chughtai, an assistant professor of urology at Weill Cornell. Such a registry would provide a powerful tool for personalized treatment recommendations, based on data from previous patients with similar characteristics and medical histories who underwent surgeries.
"With a registry we could potentially identify the correct procedure for the correct patient, and in turn, minimize harm and maximize benefits for patients," Dr. Chughtai said.