Health officials are placing new restrictions on a birth control implant.
WASHINGTON – U.S. health officials on Monday placed new restrictions on a permanent birth control implant that has been subject to reports of painful complications of thousands of women. But the metal of the implant, the so-called Essure, will remain on the market.
The Food and Drug Administration said only women who are reading this and the possibility of a brochure about the risks of the device will be able to receive the implant, and is made by Bayer. The checklist of risk should also be signed by the wife of the doctor.
The new requirement comes nearly two years after the FDA added its strongest warning to Essure, citing reported problems with the nickel-titanium implant. The agency also ordered Bayer to conduct a study of device safety.
Patients have reported cases of pain, bleeding, allergic reactions and cases where the implant is a small hole in the uterus or shifted out of place. These reports are submitted to the FDA by patients, doctors and the manufacturer.
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“Despite prior efforts to alert women of the potential complications of Essure, we know that some patients still do not receive this important information,” said FDA Commissioner Scott Gottlieb, in a statement. “That is simply unacceptable.”
An agency spokeswoman said via e-mail that the new requirements “ensure that the device continues to meet our standards for reasonable assurance of safety and effectiveness.”
In a statement after the announcement, Bayer said it will continue to tell health care providers about “the importance of appropriate supervision of each patient on the benefits and risks of Essure.”
Public health advocates, the FDA’s new requirement, which suggests that patients may not read the long brochure.
“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. “In addition to that it is much too long and technical, the information provided will be confusing to many consumers.”
Bayer received approval from the FDA to sell Essure in 2002, and in the promotion of the product for women as it is the only non-surgical option for permanent birth control. Essure consists of two nickel-titanium coils placed in the fallopian tubes, where they stimulate the growth of scar tissue blocks the sperm from fertilizing a woman’s eggs.
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Because of the reported complaints, Bayer was ordered to conduct a 2,000-patient study in 2016. Although the company is making “good progress,” the FDA said Monday that the additional research sites to enroll more patients in the study. The agency notes that the sale of Essure has fallen 70 percent since the previous FDA restrictions were announced.
Bayer facing lawsuits from about 16,000 AMERICAN women have received from Essure, according to the German conglomerate’s most recent annual report. While the company is insured against product liability lawsuits, Bayer notes that the claims of “higher than the available insurance coverage.” The company stopped the sale of Essure outside of the U.S. last year.
In the last month, the FDA reported that it had received 12,000 reports from last year about the problems with the Essure, 90 percent of which involved attempts to remove the device. The agency noted that most of the new reports came from the lawyers who are patients suing Bayer.