US health officials are placing new restrictions on a contraceptive implant that has been subject to thousands of reports of painful complications from women.
For Firmalino and her fellow Facebook group members, many of whom are now suing Bayer, the FDA’s move could signal an even more drastic change: the possibility that the manufacturer would pull Essure from the market. The patient and physician implanting the device must sign the the acknowledgment.
The agency is now requiring that Bayer, the manufacturer of the device, only sell Essure to doctors who talk patients through a two-page checklist of possible unsafe side effects before implanting the device.
To close this data gap, the FDA on Monday also ordered Bayer to submit an annual report with the number of devices sold and distributed.
However, the FDA says a minority of patients have reported sometimes unsafe complications. It said the decision to require the new patient-consent form for the procedure was based on evidence “that some women were not being adequately informed of Essure’s risks before getting the device implanted, despite previous significant efforts to educate patients and doctors about the risks associated with this device”. “That is simply unacceptable”, FDA Commissioner Scott Gottlieb said in a statement.
The FDA is mandating a unique type of restriction on the device to restrict the sale and distribution, imposing additional requirements needed to provide a reasonable assurance of its safety and effectiveness.
Specifically, health care providers must review a brochure for the device with patients to ensure they understand the risks, benefits and other details about Essure implantation.
“How many people do you know who would carefully read a 22-page document before signing it?” said Diana Zuckerman, president of the National Center for Health Research, a consumer advocacy group.
“Essure.is a safe and effective medical device that benefits women by providing them with a valuable contraception option”, Bayer said. Some patients with implanted Essure have experienced holes in the uterus or fallopian tubes, devices moving into their abdominal or pelvic cavities, persistent pain and suspected allergic or hypersensitive reactions.
Because of the reported complaints, Bayer was ordered to conduct a 2,000-patient study in 2016. The FDA will review and monitor the company’s plan and will enforce the requirements. Essure sales have fallen about 70 percent in the United States since the FDA’s 2016 actions, officials said. […]
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