Dive Brief:
- An FDA advisory committee held a public hearing this week to examine concerns about possible health complications and clinical trial issues--including alleged fraud--with Essure, a nonsurgical birth control implant which was fast tracked for FDA approval in 2002.
- The FDA has received 5,093 patient complaints of problems including chronic pelvic pain, debilitating periods, unintended pregnancies and hysterectomies required to remove devices that moved or broke apart.
- Bayer HealthCare Pharmaceuticals, which acquired Essure in 2013 from developer Conceptus Inc., maintains its confidence in the device and in the trials.
Dive Insight:
Much of the debate comes down to whether the health issues of those complaining can be attributed to the Essure device, a small coil placed in a patient's fallopian tubes. However, the real controversy is in the handling of the clinical trial.
Numerous women allege their side-effects were downplayed or attributed to other health issues, and the reports they submitted were altered.
Bayer says the alterations followed proper clinical practice procedures. “If a mistake was identified, it was crossed out, initialed and dated. … There was full transparency," Dr. Edio Zampaglione, Bayer’s vice president for United States medical affairs and women’s affairs, told Kaiser Health News.
An article in the New England Journal of Medicine this week faults the trials for "incomplete followup and biased results” and suggests adverse events were likely missed because nearly one third of the participants did not complete the trial. The authors conclude, “Though Essure offers possible advantages to women seeking sterilization, the evidence suggests that it is neither as effective nor as safe as the pre-marketing approval evaluation indicated."