According to a recent study by JAMA Internal Medicine, the use of surgical mesh for the treatment of pelvic organ prolapse (POP) has decreased after a “strongly” worded severe safety alert was published by the FDA in 2011.
FDA Warning #1: 2008
In 2008, FDA issued an initial safety notification after receiving more than 1,000 adverse event reports regarding complications associated with the use of transvaginal mesh. The alert warned the public of various complications that have resulted from the use of surgical mesh to treat POP and SUI. In this alert it almost seemed as if the Agency was downplaying the incidents, stating that these complications were experienced only in rare situations.
FDA Warning #2: 2011
Between 2008 and 2011 the FDA received an excess of 3,000 adverse event reports, which revealed a number of additional complications associated with transvaginal mesh. Due to the extraordinary volume of complaints, the Agency published a second warning regarding the safety of transvaginal mesh. In the 2011 alert, FDA stated that it was not rare for transvaginal mesh users to experience complications experienced. In addition, the alert explained that it is unclear whether transvaginal mesh is more effective in treating POP than the more traditional, non-mesh methods.
2008 vs. 2011 Safety Warnings
According to the results of JAMA’s recent study, following the publication of the 2008 safety warning, the use of transvaginal mesh increased from 21% to 30% of all procedures between 2008 and 2011. However, transvaginal mesh use fell after the Agency’s 2011 warning was published, from 30% of all procedures in 2011 to 23% in 2013.
The study was conducted using data from the New York Statewide Planning and Research Cooperative System, and stated that the variations in use after each warning was published could be a result of the “stronger language” used in the 2011 alert. Furthermore, the study also found that the decrease in use of transvaginal mesh was greater in non-teaching and lower-volume hospitals. Researchers explained the difference by saying that it could be due to these types of hospitals having a “lower tolerance for litigation,” or simply that they tend to treat patient’s suffering from less severe cases of POP.
What is happening with Transvaginal Mesh today?
In January of this year, the FDA issued two final orders intended to increase the regulation of surgical mesh for the treatment of POP. Additional information on the increased regulatory requirements is available in our FDA News article entitled “FDA Strengthens Regulatory Requirements for Transvaginal Mesh.”
Do you manufacturer a surgical mesh product? Are you in the process of developing a mesh device to treat POP? Regardless of where you are in the process, we can ensure that you are compliant with the regulatory requirements for medical devices, as well as any other FDA-regulated products. To learn more about our services, contact us today.
