Last week, an FDA advisory panel met to discuss one issuethe increasing number of adverse event complaints stemming from Essure insertions in the US. The Essure device, a metal coil implant placed in a womans fallopian tubes, is the only device approved in the US for the purpose of permanent birth control. Since it was first launched in 2002, it has experienced high adoption due to its short procedure time and minimally invasive insertion technique that can even be performed in a physicians office. However, there have been growing concerns regarding the safety and efficacy of the device starting from 2013 when media outlets and social media groups started to bring about awareness of severe side effects. During this time, the FDA and manufacturer Bayer Healthcare maintained a stance that the device was still effective and safe.
Now fast forward two years, and in 2015, the issue has escalated to a citizens petition and a recommendation from the advisory committee to limit use of Essure until more research is conducted to prove its safety. While there is no idea as to how the FDA should move going forward or when a formal decision by the FDA will be made, this brings about certain implications on the market growth for female sterilization devices. Looking at the market for gynecological devices, weve seen major declines in transvaginal mesh markets and laparoscopic morcellator markets, which have had similar controversies on patient safety, so could Essure become another?
Given what happened with transvaginal mesh marketsthe FDA mandated post-market surveillance studies, which resulted in a decline in all markets despite the issue largely stemming synthetic PFR mesh kitsone potential outcome is a decline in all female sterilization procedures. It is an elective procedure overall, so the overall negative perceptions could dampen overall interest for patients considering this option. That said, surgical options are still available and have historically been known to be safe and effective. In the case of laparoscopic morcellators, these devices were prized for their ease-of-use but were found to be dangerous because of the potential of spreading cancerous cells. They remain a great product for benign lesions but the risk combined with overall negative perceptions have taken surgeons back to traditional manual surgical techniques. Similarly, the concerns with Essure could then just drive patients back to traditional methods, such as bipolar or Filshie clip sterilizations, where manufacturers of those devices like Olympus and CooperSurgical could benefit. In the end, one thing is for sure: the patient should be the primary beneficiary. If at the end of this, patients are being given all their options and the information and advice they need to make the educated decision, then whatever the device or surgical technique, everyone benefits.