July 28, 2015, Fierce Pharma

Papal visit coincides with FDA panel meeting for Bayer's Essure, riles advocates

Last month, the FDA scheduled a September panel meeting to take a hard look at Bayer's controversial birth control device, Essure, after getting complaints of clinical trial fraud and serious side effects tied to the product. Now, the agency is facing more pushback from women campaigning against the device, who claim that regulators purposely selected the panel meeting date to coincide with a visit from the pope.

As the Catholic News Agency reports, Pope Francis will give the first-ever papal address to Congress on Sept. 24--something the FDA was well aware of when it scheduled its meeting, Angela Desa-Lynch, an administrator for the Facebook group "Essure Problems" told the news outlet. The group, which was spearheaded by famed activist Erin Brockovich, has more than 9,000 members and is lobbying for Bayer to remove its product from the market. In response to the FDA's scheduling decision, Essure Problems is planning to launch a hunger strike along with other advocacy groups after the Sept. 24 meeting.

The FDA is denying any deliberate scheduling snafus, saying "the meeting was not timed in any way with the Pope's address to Congress," agency spokeswoman Deborah Kotz told the CNA in an email. Regulators announced the meeting date for Essure on June 24, while the Vatican released the pope's U.S. visit itinerary on June 30, she added. But the pope's Sept. 24 address to Congress was publicized as early as Feb. 5, according to the CNA story. Bayer declined to comment to the news outlet.

Bayer has faced a rocky road with Essure since picking up the device in 2013 through its $1.1 billion acquisition of Conceptus. In April, the FDA said it would investigate Essure following complaints of fraud during the clinical trial and claims of serious side effects. The agency has received more than 5,000 complaints about the device since it was approved in November 2002, and most are from after Bayer acquired the product.

The company is standing by its device, releasing data in May from a long-term study to support the safety and efficacy of its Essure implants. The device, which consists of two flexible metal fiber coils placed in the fallopian tubes, only caused pelvic pain in 7% of participants in the 5-year follow-up study, Bayer said at the time. "The results of this study, which are consistent with other published literature on Essure, document the extended 5-year effectiveness, safety and tolerability of Essure inserts," Dr. John Nichols Jr., a study investigator, said in a statement.

But an article published by The New York Times called the company's data into question, citing results from a long-term trial published in the Journal of Minimally Invasive Gynecology. Only 366 out of 518 original study participants were followed for the full 5 years, according to the NYT article. And women who were tracked still cited a number of problems tied to the device, including unusually heavy periods and recurrent pelvic pain. Bayer struck back at the article, claiming in a letter to the editor that the story "mischaracterizes" its recent long-term study of the device, and that the trial mentioned in the article actually "reinforces the safety and efficacy of the device and the procedure," the company said. By Emily Wasserman

more information:
=> Speech in Bayer Shareholder Meeting
=> First Essure charge filed
=> Interview with Erin Brockovich
=> Essure Problems site