UPDATED March 10, 2015, with comment from Bayer.
A citizens petition lodged with the FDA last month wants the safety watchdog to take healthcare giant Bayer‘s (PINK:BAYRY) Essure permanent female sterilization device off the market, alleged that the clinical data the FDA used to approve the device was fudged and that the company concealed adverse events associated with Essure.
"The PMA process for Essure was replete with fraud on the FDA including the altering of medical records of trial participants," the Feb. 25 petition alleges.
Essure is part of the product portfolio Bayer acquired in the $1.1 billion buyout of Conceptus in 2013. Conceptus won FDA approval for Essure in 2002 under an expedited pre-market approval process. The device is a permanent form of birth control, comprised of flexible inserts that are implanted in the fallopian tubes where scar tissue forms around them. Essure is the only permanent contraceptive option that requires no incisions, the FDA has said, and the device contains no hormones and can be placed without need for anesthesia.
Patients and a prominent activist struck up a hue and cry almost immediately after Bayer’s buyout of Conceptus, agitated for the device to be taken off the market and for Bayer to launch a complete investigation into patient injury claims. But in October 2013 the FDA said that real-world results don’t support reports of extreme fatigue, depression, weight-gain and other issues associated with the implant.
The latest petition goes a step beyond accusations of health risks to level charges of fraud against Bayer and Conceptus.
"Medical records of trial participants were altered to reflect (1) favorable data, including less pain then was experienced and (2) certain birth dates," the petition alleges, citing the experience of Kimberly Hudak, a trial participant for the Essure device.
Hudak’s medical records "were altered to reflect less pain then she was experiencing and her answers were physically crossed out and fraudulently changed by the applicant as it related to affirmative findings of pain, adverse events, unusual pain, and unusual health related events," according to the petition filed by Florida law firm Koch Parafinczuk & Wolf [emphasis theirs]. "In fact, when Kimberly Hudak was reporting severe pain to the clinical trial doctor, Dr. Linda Bradley, the applicant was noting that Kimberly Hudak’s level of comfort was ‘excellent.’"
In another incident alleged in the petition, clinical trial participant Patricia Reese’s birth date was altered to ensure that she met the age requirements of the trial.
"Patricia Reese’s birth date was changed or somehow altered from 3/27/76 to 3/27/56, which raises the question as to why this was done? It is clear that the records were altered considering earlier records from the applicant’s doctor conducting the trial studies contained her correct date of birth," according to the petition.
Bayer spokeswoman Tara DiFlumeri told MassDevice.com via email that, under good clinical practice guidelines, "it is not uncommon for investigators to make edits prior to finalization on investigational reports."
"Although we cannot discuss individual clinical trial participants, we have seen the materials submitted with the citizen’s petition and strongly disagree with those allegations," DiFlumeri wrote.
The petition also alleges that Conceptus and later Bayer failed to report adverse events associated with Essure to the FDA, as required by the device’s PMA, including an Excel file containing some 16,047 complaints. DiFlumeri told us that Conceptus provided the Excel file to the FDA before its acquisition by Bayer.
"FDA acknowledged receipt of the CD-ROM in an establishment inspection report sent to Bayer on June 26, 2013. There was no failure to notify FDA of these complaints as alleged by the petitioner," she wrote. "Bayer stands behind the safety and efficacy of Essure and will aggressively defend itself in court. Bayer will also continue to work with the FDA on this issue and will respond to any questions the agency may have related to this citizen’s petition."
The FDA acknowledged receipt of the petition but said it hasn’t made a decision on the allegations.
