Then the mother of five remembered her Essure birth control device – nickel titanium coils – implanted in 2013.
Advertisement
The panel of doctors-which didn’t take a formal vote-was reacting to a parade of witnesses who described yearslong debilitating pain and other symptoms in testimony before a Food and Drug Administration advisory committee examining Essure, which Bayer acquired in a 2013 merger.
Women told of autoimmune problems such as eczema, lupus, celiac disease, of cysts, abscesses and tumors, of severe fatigue and losing control of their bowels, and of odysseys through the health care system in search of diagnoses.
The US regulatory agency said it has found over 20,000 complaints that women have shared with others on a special Twitter and Facebook page.
Some patients spoke of sleeping virtually nonstop after getting the Essure device. The problems are linked to bleeding, chronic pain, headaches, and in some instances unwanted pregnancy. An estimated 1 million Essure devices have been sold around the world, according to its maker, Bayer Healthcare Pharmaceuticals.
Essure consists of two tiny, metallic coils that are inserted into the fallopian tubes, where they are meant to trigger the growth of scar tissue that eventually blocks sperm. The Essure complaints, filed in the U.S. District Court, Eastern District of Pennsylvania, contend that the company’s actions invalidates Essure’s conditional approval by the FDA. The news is cold comfort to those who wanted to see Essure pulled from the market, arguing the FDA failed to properly assess the medical device’s safety and efficacy and ignored the complaints of women over the years.
She also asked the agency to force Bayer to fund a national registry of Essure patients so that more data can be collected and analyzed about Essure that is not controlled by the manufacturer. In its response, Bayer, which acquired Conceptus in 2013, is asking for dismissal of the claims because the company is shielded from Essure product liability lawsuits.
Dr. Edio Zampaglione, Bayer’s vice president for United States medical affairs and women’s affairs said “It seems like the proper clinical practice procedures were followed”. An emergency room nurse in New York, Mendez said she liked the idea that it could be implanted via a quick, in-office procedure. “The hair loss was pretty devastating, I would say the worst part for me was my family was making memories without me, because I wasn’t able to participate in a lot of things because I was home sick”. Essure is over 99% effective at permanently preventing pregnancy.
“I’ve had no problems”, she said.
Advertisement
“They had no concern for me”, said Huddleston, now 39, who still has chronic pelvic pain. In a review of the device before this week’s planned meeting, the FDA said “significant limitations must be taken into account when reviewing the data”, on the device.
