Essure Contraceptive Device Tied to Fetal Deaths
By David Carnes, Staff Writer
Essure is a permanent contraceptive device, in which coils are implanted into the fallopian tubes, that has been billed as an alternative to tubal ligation. It was approved by the U.S. Food and Drug Administration (FDA) in 2002. Since then its sales have topped 750,000 devices, mostly in U.S. Unfortunately, it appears that the FDA greatly underestimated the health risks of this device, as it has been the subject of tens of thousands of complaints.
The FDA admits that Essure has been responsible for at least five fetal deaths linked to Essure. Private watchdog organization Device Events, however, claims to have discovered evidence of over 300 fetal deaths from the FDA’s own records by combing those records more thoroughly than the FDA does when it formulates its reports. Other reported risks and adverse events of Essure implants include:
- Long-term pain
- Perforation of the uterus
- Perforation of the fallopian tubes
- Migration of the device inside the body
- Internal bleeding
- Allergic reactions
A recent complaint filed in a federal court in California alleges that Conceptus, the original manufacturer of Essure, offered a group of doctors tens of thousands of dollars for agreeing to buy 25 Essure kits. The same complaint alleges that Essure sales personnel organized lunches between primary care doctors and specialists such as obstetricians and gynecologists, in order to reward specialists who recommended Essure most frequently with contacts among primary care doctors who would likely generate referrals. If true, this practice could amount to an illegal kickback scheme that rewarded specialists for recommending Essure based on the prospect of personal financial gin rather than dispassionate professional judgment.
Over 20,000 women have complained about the health risks of the Essure device, and a victims’ lobbying group originally founded on Facebook is seeking to have the device recalled by the FDA. A Pennsylvania state legislator has even introduced a bill that would demand that the FDA recall the device. Although it is unlikely that a state law could force a federal agency such as the FDA to act against its will, the bill does illustrate the political pressure that is beginning to build against the FDA over its refusal to recall this device.
The FDA Reaction
On February 29, 2016, the FDA responded to public pressure by requiring new warnings for Essure and by requiring Bayer to perform a new study of the device’s risks and benefits that involves at least 2,000 participants. The FDA’s “black box” warning will advise users of possible adverse events such as perforation of the uterus, migration inside the body and allergic reactions, among other dangers. The study is unlikely to be completed for several years.
The 21st Century Cures Act
The Essure controversy has taken place against a rather discouraging legal background – the prospect of passage of the 21st Century Cures Act, a pending bill that sailed through the House of Representatives in uncharacteristically bipartisan style. Critics maintain that if this bill becomes law, new medical devices will be rushed onto the market with inadequate FDA supervision and testing, resulting in many more Essure-type fiascos in the future.