This week, the Food and Drug Administration finished its investigation of a complaint alleging that Bayer, manufacturer of the Essure contraception device, engaged in “clinical trial misconduct” by manipulating data. The federal regulatory agency determined there was no indication of Bayer altering any data during the clinical trial in question.
The allegations against the pharmaceutical giant stated that “clinical trial participants’ medical records were altered to reflect more favorable data about participants’ experiences [with Essure].” It also accused Bayer of violating the Pre-marketing approval (PMA) order as well as illegal conduct in regards to the manufacturing and marketing of the birth control device.
According to FDA investigators, Bayer cooperated throughout the process, furnishing documentation of subjects’ responses to the clinical trials. The FDA’s final report said “less than 1% of case report form data pertaining to pain, bleeding, device placement/movement and pregnancy were changed during the clinical trials…although modifications to the case report forms were identified, our analysis did not find evidence the sponsor purposefully modified patient responses to reflect more favorable data for Essure.”
While this appears to put Bayer in the clear, there are a few issues with the investigation – primarily, it was done many years after the FDA granted premarket approval for Essure. The original data presented to the FDA for premarket approval was gathered prior to 2002, when that approval was granted. While FDA investigators were able to review the case report files, the original lab records and researchers’ notes were not available. Because of this, there was no way to determine whether or not the case report files were complete or the information entered was accurate.
In any event, the FDA’s conclusions won’t get Bayer off the hook. Earlier this year, Bayer attempted to get a number of lawsuits dismissed on a various grounds, including jurisdiction issues and arguments that the statute of limitations had expired on the cases. On August 2, the California Superior Court of Alameda County rejected the defendant’s arguments and ruled that the lawsuits could go forward.
Since Essure’s approval in 2002, the FDA has received nearly 5100 complaints about Essure. These complaints include pain, menstrual irregularities, miscarriages, pregnancies after having the device implanted, and deaths from infections and perforation of the uterus. Nearly half of these complaints were filed only last year, representing an increase of nearly 1400%.
This year, over 1300 complaints have been filed. In addition to these formal complaints, approximately 17,000 women who have suffered from the Essure device are part of a social media group called “Essure Problems.” Complaints posted to the group include ongoing pain, profuse bleeding and skin rashes. Angela Lynch, who started the group, got the Essure device when she was 28 years old. She says, “After 2 years I started losing hair. Then I started losing teeth, and over time it got to where my whole body was hurting.”
Ms. Lynch is only one of many – and Bayer still needs to be held accountable.