The FDA recently announced that it is investigating allegations of improprieties in conjunction with clinical trials that were conducted by Bayer and Conceptus with regard to the Essure device, which is utilized in sterilization procedures. Bayer Corporation, a German pharmaceutical giant, purchased Conceptus, the original designer of the Essure device, in 2013 for $1.1 billion.
This latest inquiry was prompted by consumer petitions to the FDA that raised concerns about the validity of safety data reported to the agency as well as reports of serious injuries to a number of patients who were implanted with the device. A New York Times article published a few days ago noted some concerns over the accuracy of safety data from a recent five-year study of patients, as not all patients were reportedly followed for the entire period covered by the study.
The Essure device was approved through the PMA process by the FDA in 2002. The FDA’s Premarket Approval process is the most rigorous evaluation undertaken by the FDA for review of the safety and efficacy of a medical device prior to marketing, but the FDA does not conduct independent testing and most rely on the device’s sponsors to submit accurate and reliable data and information with regard to potential harm that the medical product might cause to patients. The Essure contraceptive insert in placed in a woman’s body through a hysteroscope and blocks the fallopian tubes, which results in permanent birth control.
In 2013, the FDA conducted a safety review of the device after receiving nearly 1,000 adverse event reports from women who alleged that they had been injured by the device. The safety concerns lodged by patients and implanting physicians included a number of reports of hemorrhaging, migration or malpositioning of the device, product breakage, pelvic pain, abnormal menstrual bleeding, and the need for hysterectomies due to complications caused by the product. At the time of its 2013 safety analysis, the FDA concluded that the product should stay on the market but did provide more in-depth information regarding the risks of the device, which is pretty standard procedure for the medical device agency which has been historically reluctant to favor device recall over more stringent warnings