FDA to Investigate Bayer's Essure Contraceptive Device

Troy Brown, RN

April 03, 2015

UPDATED April 14, 2015 // The US Food and Drug Administration (FDA) has opened an investigation of the Essure (Bayer Healthcare Pharmaceuticals Inc) permanent contraceptive device after allegations that the company falsified and altered medical records during clinical trials, failed to report adverse events, deceived the public and the FDA about the device's safety and efficacy, and used defective materials in manufacturing, according to a petition from the Law Offices of Koch Parafinczuk & Wolf, PA.

The petition was filed on behalf of hundreds of women who complained of adverse events including organ perforation, device migration out of the fallopian tubes, and pain.

"We've [also] filed five lawsuits in Pennsylvania," Marcus J. Susen, an attorney with the petitioning law firm, told Medscape Medical News.

Bayer, in a statement, says the company "stands behind the safety and efficacy of Essure and will aggressively defend itself in Court."

The petitioners, Marcus J. Susen and Justin Parafinczuk, have asked the FDA to "issue orders relating to disclosures and findings, variously modify premarket approval terms, and initiate a recall," based on claims that "the product sponsor perpetrated fraud with respect to clinical trials; the sponsor violated the terms of the [premarket approval]; and federal laws were violated," according to a letter from William H. Maisel, MD, MPH, chief scientist of the FDA's Center for Devices and Radiological Health (CDRH), to the petitioners.

Dr Maisel wrote that "the Office of Compliance will pursue actions as deemed necessary" in a response to a citizen petition. "However, CDRH does not provide information during the investigation, nor does it provide explanations of the outcome of the investigation to the correspondent who made the complaint."

The Essure device is a small flexible coil that is inserted into the fallopian tube through the cervix and uterus and causes inflammation that permanently blocks the fallopian tube by approximately 3 months after insertion. The device is placed in each fallopian tube in a physician's office.

Bayer purchased the device when it acquired Conceptus, the original marketer of the device, in 2013.

Fraudulent Clinical Trial Data

The petitioners allege that the company altered the medical records of at least two patients during clinical trials. In one patient's case, information that she provided on a questionnaire about unusual health problems and pain related to the device was crossed out and changed to indicate that she was having no pain or unusual health problems. In another patient's case, her birth date was changed from March 27, 1976 to March 27, 1956, to conform to FDA premarket approval requirements.

Failure to Report Adverse Events

The petition alleges the company failed to report to the FDA adverse events that resulted from the device, including perforation of bowels, device coils breaking into pieces, and coils that migrated out of the fallopian tubes. The company is accused of having information regarding 168 perforations but only disclosed 22 to the FDA. In addition, the company is alleged to have an "internal excel file" that contained 16,047 entries of complaints, which it did not provide to the FDA.

Misleading Claims About Safety and Efficacy

The petitioners allege that the company gave false information about the device numerous times. The company claims that no pregnancies occurred during clinical trials, but the petition claims that four pregnancies occurred during clinical trials, and five pregnancies occurred during the first year in commercial use. The company was allegedly aware of 64 pregnancies that occurred between 1997 and 2005 and concealed this information from patients. In addition, more than 30 pregnancies occurred after follow-up testing at 3 months indicated the device had successfully blocked the fallopian tubes, according to the petition.

The company claimed that the Essure device is the most effective permanent contraceptive available, even surpassing tubal ligation and vasectomy, when they had allegedly conducted no testing that compared Essure with those procedures.

Used Defective Materials in Manufacturing

In July 2003, the company was cited for failing "to identify existing and potential causes of non-conforming product and other quality problems," according to the petition. The petition alleges that two lot history records indicated rejected raw material that was not recorded on a quality assurance form, which is used to track this data. For this reason, it is unclear "where the rejected components went."

Bayer Responds

Requests made to Bayer for comments were not returned by publishing time, but multiple media outlets report that a Bayer spokeswoman released this statement about the investigation:

"The Citizen's Petition regarding Essure was submitted to the FDA by a law firm that has filed several Essure product liability lawsuits naming Bayer as a defendant. The allegations made in the Citizen's Petition are similar to those stated in the lawsuits. Bayer stands behind the safety and efficacy of Essure and will aggressively defend itself in Court. FDA has closed the petition and forwarded it to the Office of Compliance. We will respond to any questions that they may have related to the petition."

More information about Essure is available on the FDA website.

(Editor's note: This article was updated on April 14, 2015, to include information about lawsuits filed by Koch Parafinczuk & Wolf as well as links to related information from the FDA and Bayer.)


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