Bayer Healthcare Pharmaceuticals, Essure’s manufacturer, defends that their device is still safe to use and that, despite the relentless social media campaign against it, the adverse reactions on Essure affected only a small percentage of users. A Bayer executive, Dr. Andrea Machlitt, said of the 17,000 so-called “adverse event reports”, which flag problems, 15,000 had been in the United States.
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Bayer’s contraceptive device, Essure, will be reviewed by USA health experts later this week, following an increasing number of complaints over potential Essure side effects.
Studies suggest problems with Essure are relatively rare, but thousands of women have attributed various health problems to the implant. After more than 20 doctor visits, her physician agreed it was necessary to remove the device, she said. Some of them discussed minor symptoms, like fatigue, while others addressed more serious issues, like the implant becoming dislodged, heavy bleeding.
The Essure device is inserted through the cervix into a woman’s fallopian tubes where it triggers inflammation and the growth of fibrous tissue, blocking the pathway between sperm and egg.
However, the FDA has found no conclusive evidence linking those cases to the device.
Bayer continued to stand by the device, saying its safety “is supported by more than a decade of science, with more than 10,000 women studied”.
“Within 12 months of placement I developed pain throughout my entire body”, said Kim Hudak, who had was part of the clinical trials for Essure. The FDA called an outside panel for reviewing the safety of this device recently since thousands of women were complaining of a number of complications.
The audience at Thursday’s meeting included dozens of women pushing for the withdrawal of Essure who frequently applauded critical comments by the panelists. 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. When Lacey Gay used it, she says the only thing it prevented was her from living a full life.
Dr. Patricia Carney, the organization’s medicinal executive for Essure, said the organization respects the talk.
Krystal Donahue of Maryland testified that she experienced “physical pain, abdominal pain for more than two years”.
No form of contraception is without risk, should be considered appropriate for every woman or is considered 100 percent effective.
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In those records, Bradley wrote on her chart on January 28, 2002, that the cause of the back pain, which was worse before her menstrual period, was unknown but “does not appear to be gynecologic”. “I have hip pain”, said Pamela Ackerman, who now has the coils but plans to get them surgically removed. But the panel said real-world data showed the devices actually break down earlier than older implants, exposing patients to tiny, metallic shards.
