Using data from three national private insurers, our analysis reveals a 21% decrease in the annual utilization of all procedures for POP from 2010 to 2013. Over the 4 years, the decrease in the utilization of procedures with mesh was twofold greater than those without mesh; however, the utilization of procedures without mesh also significantly declined. Before July 2011, the utilization rate of procedures with mesh was increasing and then sharply declined after the FDA safety communication was released. These findings support prior studies describing an increase in mesh procedures during the years preceding 2011.13–16 Our findings highlight a previously undescribed decrease in surgical management of prolapse, regardless of mesh use, during a time when the need for prolapse surgery on a national level was projected to rise.3,4,17
There are several possible reasons for the decrease in POP procedures. Hospital policies and physician practice may have changed in response to the reports of complications from mesh and the FDA safety communications in 2008 and 2011.2,8 The number of physicians privileged to use mesh may have changed when hospitals reacted to guidelines regarding surgeon privileges, the consent process, and outcomes reporting.18,19 Simultaneously, subspecialty physicians may have become more selective about mesh procedures and changed the procedures they perform. Physicians have reported that after the 2011 FDA safety communication, they were less likely to use mesh in a vaginal repair of recurrent prolapse and more likely to use an abdominal approach for primary prolapse repairs.20 Finally, patients may have become more reluctant to consider surgery for prolapse given the media coverage about mesh-related complications.21,22
Claims data from inpatient and outpatient settings allowed us to identify changes in surgical practice for prolapse. Surgery for prolapse is now more often performed as an outpatient procedure compared with inpatient. Sanses et al reported a 29% decrease in inpatient procedures in the decade before 2011. This change in practice is now occurring at a more rapid pace with a 52.2% decrease in inpatient procedures and a 18.5% increase in outpatient procedures over a 4-year period.10 This outpatient shift may be related to the observed increase in hysterectomies performed laparoscopically. Given the outpatient shift, it will be important for future research to use data sets that include outpatient claims.
Average expenditures for prolapse procedures continue to increase. We found that prolapse surgery became 7.5% more expensive between 2010 and 2013—a surprising development considering the large shift from inpatient to outpatient surgery—and that outpatient procedures were 40% less expensive than inpatient procedures. The majority of the payment increase was seen in the insurance portion, because patient payments remained stable.
There is some evidence to explain why surgery for prolapse became more expensive. First, the proportion of hysterectomies for prolapse performed vaginally, the least expensive and morbid surgical approach, decreased 34%, whereas the utilization of more expensive laparoscopic hysterectomy increased 103%.23 Second, the average outpatient cost of a case involving mesh was $1,823 (40%) higher than a case that did not use mesh. It is possible that a growing proportion of gynecologic surgeons now favor laparoscopic repairs with mesh, which are associated with higher expense, over vaginal surgery. A final factor affecting the changing payments is that hospitals and insurance companies often negotiate payment contracts, which can affect these outcomes, and may be unrelated to clinical factors.
Although the findings among women with private insurance may not apply to women with Medicare, Medicaid, or no insurance, this study's primary strength is its generalizability, because this database provides data for more than 25 million commercially insured women from all 50 states. The use of deidentified claims data is a limitation. We are unable to distinguish between biological and synthetic mesh with current International Statistical Classification of Diseases and Related Health Problems, 9th Revision procedure codes and we are unable to determine whether current coding practices accurately distinguish between conventional and robot-assisted laparoscopy. Therefore, robot-assisted surgeries were considered laparoscopic procedures. Additionally, only one Current Procedural Terminology, 4th Edition code could be recorded per procedure, and as such, we were unable to sufficiently distinguish between vaginal and abdominal colpopexy. Finally, hospital and insurance payments do not necessarily reflect actual cost.
Clinically, the FDA safety communication appears to have led to a change in surgical practice regarding the treatment of POP. Future studies are needed to identify the cause of the declining number of prolapse procedures despite an aging population and a projected increase in need as well as to examine factors that account for the observed rise in hospital payments.
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/downloads/medicaldevices/safety/alertsandnotices/ucm262760.pdf. Retrieved February 1, 2017.
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