In this population-based analysis of more than 60,000 pelvic organ prolapse procedures utilizing mesh, vaginal mesh represented the majority (74.9%) of surgeries. From 2005 to 2010, there has been a significant increase in prolapse mesh procedures, largely due to the increase in VM, since rates of sacrocolpopexies (both ASC and MISC) remained relatively low. Interestingly, the rate of ASC declined over this time period while the rate of MISC increased. As for trends based on age, VM was the most common procedure across all age groups. Despite the initial FDA public health notification in October 2008,2
we did not see evidence of a dramatic decrease in the rate of VM procedures after 2008 but this rate did appear to level off from 2008 – 2010.
Our CPT-based approach to describe mesh use during prolapse surgery is novel, as prior literature is limited. In 2010, the FDA estimated that of the 300,000 prolapse surgeries performed annually, one-third utilized mesh grafts.6
Our finding that 74.9% of the mesh procedures were VM mirrors industry estimates that three-quarters of mesh procedures are transvaginal. These data confirm the popularity of these surgeries in current practice.
The high rate of VM procedures further emphasizes the importance of potentially serious complications of these procedures. The FDA July 2011 update stated that there were 1,503 reported complications associated with surgical mesh devices for prolapse from January 1, 2008 through December 31, 2010.1
The most common complications included “mesh erosion through the vagina (also called exposure, extrusion or protrusion), pain, infection, bleeding, pain during sexual intercourse (dyspareunia), organ perforation, and urinary problems. There were also reports of recurrent prolapse, neuro-muscular problems, vaginal scarring/shrinkage, and emotional problems”.1
Unfortunately, many of these complications required additional interventions, and anecdotally, many urogynecologists are witnessing a dramatic increase in the number of patients with mesh complications in their practices. While the existing literature suggests that there may be a role for mesh augmentation in the anterior compartment for improved anatomic success 3, 6, 15, 16
, the FDA stated that it is not clear that that mesh augmentation is more effective than compared to native tissue repairs.1, 6
In their joint committee opinion, ACOG and AUGS recommended that mesh augmentation be reserved for high-risk individuals in whom the benefit of mesh placement outweighs the potential risks.3
While the initial FDA notification in 2008 did not have a dramatic impact on VM rates, it will be important to monitor the impact of the July 2011 update on rates of VM procedures in the coming years.
In addition to an increase in VM procedures from 2005 to 2010, our data shows an increase in the MISC rate and a decrease in ASC rate over the study period. Because of the limited detail of CPT codes in current use, we are unable to distinguish between laparoscopic and robotic-assisted sacrocolpopexies, and we cannot definitively state what proportion of MISC is due to each of these approaches. Jones et al.9
showed that laparoscopic prolapse surgeries increased among inpatients from 1979 to 2006, and Bradley et al.10
reported that minimally-invasive inpatient prolapse procedures increased from 4.8% in 1998 to 9.4% in 2007. While the laparoscopic sacrocolpopexy was first described in 1994 17
, the robotic-assisted approached was first reported in 2004.18, 19
In 2005, the da Vinci Surgical System (Intuitive Surgical, Inc., Sunnyvale, CA) was approved by the FDA for use in gynecology.20
Given this timeline, we postulate the greater proportion of the increase in the MISC rate may be secondary to an increase in the number of robotic-assisted sacrocolpopexies.
In our study, we found that a total hysterectomy (TAH) was more common than a supracervical hysterectomy (SCH) for both ASC and MISC. The literature is conflicting regarding the relationship of type of hysterectomy and the risk of mesh erosion.(22) Several studies suggest that there may be no difference between the risk of mesh erosion after ASC between TAH and SCH.21, 22
However, a large randomized multi-centered study found an increased risk of mesh or suture erosion with ASC with concomitant TAH (14%) compared to those with a prior hysterectomy (4%).23
Furthermore, two studies which assessed robotic-assisted MISC found no erosions among subjects who had concomitant SCH.24, 25
These data suggest concurrent SCH may decrease the risk of mesh erosion following a sacrocolpopexy. However, minimally invasive SCH is not without its trade-offs, as there is the need for continued cervical cancer screening and the risk of unanticipated premalignant or malignant uterine pathology in a morcellated SCH specimen,.25–27
Further research and education regarding hysterectomy choice and ASC and MISC is warranted.
The largest proportion of mesh prolapse surgeries in our study was performed in women aged 60–69 years. This age range is similar to that of prior studies investigating inpatient prolapse surgery trends in the U.S, as most procedures were performed in women aged 60–79 years.10, 28
Prior investigations have also shown the mean age of women undergoing both inpatient and outpatient prolapse surgery in the U.S. has increased over the last decade.8, 9
Regional trends have consistently shown that the South has the highest rates of prolapse surgery, though this is largely unexplained.9, 10, 28
This trend could potentially be related several factors: the increased tendency of physicians in the South to perform surgery for prolapse, a higher prevalence of disease in the South, or greater preference of surgery as a treatment option for prolapse among Southern women. These factors have not been thoroughly investigated or well explored.
In this study, we present data regarding the rates of prolapse procedures which involve the use of mesh. The strengths of this study include the use of a population-based database of adjudicated healthcare claims, which provides an exceptionally large cohort to evaluate. Furthermore, the utilization of CPT versus ICD-9 codes allowed us to evaluate specific prolapse procedures - i.e. VM vs ASC vs MISC, as well as the whether these procedures were performed on an inpatient or outpatient basis. Lastly, we evaluated trends starting in 2005, as the CPT vaginal mesh codes were introduced that year. Evaluation of prolapse mesh procedures prior to 2005 may not be particularly accurate as specific codes were not available.
Regarding limitations, it is possible that some VM procedures were not appropriately coded in 2005, as CPT code 57267 was introduced that year; however, the significant upward trend in VM rates suggests that there has likely been an increase in the use of these procedures. Another factor is that we did not have details regarding the surgical procedure in terms of the type of mesh utilized as well as the method in which mesh was placed. For MISC, the CPT code 57425 for laparoscopic colpopexy could also represent laparoscopic uterosacral ligament suspensions; thus it is possible that we may have slightly overestimated the rate of sacral colpopexies utilizing mesh. In addition, we were unable to evaluate certain demographic or clinical factors, such race, body mass index (BMI), indication for surgery (i.e. primary prolapse surgery or surgery for recurrent prolapse), or stage of prolapse. Lastly, our database included only those with employer-based insurance, and thus our results may not be generalizable to those without other types of insurance or self-pay patients. Fortunately, with the Medicare supplemental database, we were able to evaluate older women who had employer-based insurance and then transitioned into Medicare at 65 years of age.
In conclusion, transvaginal mesh procedures comprised 75% of all prolapse mesh surgeries, and VM was the most common mesh procedure across all age groups. Although rates of vaginal mesh procedures were significantly higher than abdominal and minimally-invasive sacrocolpopexies, the rate of MISC increased while that of the ASC decreased from 2005 to 2010. Although we did not see a dramatic decrease in the rate of VM procedures after the initial FDA public health notification in 2008, the rate of VM appeared to level off from 2008–2010. It will be important to evaluate the impact of the July 2011 FDA notification, as this statement highlighted serious complications after transvaginal mesh prolapse surgery more emphatically than the 2008 statement. Beyond evaluating trends in surgery rates, future studies should strive for rigorous, comparative effectiveness studies that incorporate patient-centered outcome measures as well as long-term, population-based data regarding complications of vaginal mesh. Despite the popularity of VM procedures, population-based data regarding the rates of repeat surgery to manage complications such as mesh erosion/exposure and mesh contracture are strikingly lacking.