American health officials on Monday introduced new restrictions on permanent implant contraceptive, which was the subject of reports of painful complications of thousands of women. But a metallic implant called Essure, will remain on the market.
The food and drug administration said that only women who read and have the opportunity to sign a brochure about the risks of the device will be able to get the implant, manufactured by Bayer. The list of risks should also be signed by a doctor women.
A new requirement for almost two years after the FDA added its strictest warning Essure, citing problems with Nickel-titanium implants. The Agency also ordered Bayer to conduct a study of the safety device.
Patients have reported cases where pain, bleeding, allergic reactions and cases where the implant is punctured the uterus or migrated out of place. These reports were submitted to the FDA for patients, doctors and the manufacturer.
“Despite previous efforts to alert women to the potential complications of Essure, we know that some patients are still not receiving this important information,” said FDA Commissioner Scott Gottlieb in a statement. “It’s just unacceptable.”
Press Secretary of the Agency, said via email that the new requirements “make sure the device still meets our standards for a reasonable assurance of safety and effectiveness.”
In a statement after the announcement, said that “Bayer” will continue to inform health care workers about the “importance of proper counseling of every patient about the benefits and risks of Essure”.
Defenders of public health questioned new requirements of the FDA suggesting that patients may not read a lengthy brochure.
“How many people do you know who have carefully read the 22-page document before signing it?”, said Diana Zuckerman, President National research center of health, group for the protection of the rights of consumers. “Besides being too long and technical, the information provided will be confusing for many consumers.”
Bayer received FDA approval for sale Essure in 2002, and promoted the product for women as the only Non-surgical option for permanent birth control. Essure consists of two Nickel-titanium coils inserted into the fallopian tubes where they stimulate the growth of scar tissue that blocks the sperm fertilization of the egg of the woman.
Because of reports on complaints, Bayer was ordered to conduct a 2,000-patient study in 2016. Although the company is making “adequate progress,” the FDA said Monday that it will require additional study sites to enroll patients in the study. The Agency notes that sales of Essure has fallen by 70 per cent as was previously announced restrictions, and medications.
Bayer is facing lawsuits from about 16,000 American women who received Essure, according to the latest report of the German conglomerate. While the company is insured against claims of responsibility for the quality of products, Bayer notes that the claim “exceeds the available insurance.” The company stopped selling Essure outside of the United States last year.
Last month, the FDA announced that it had received 12,000 reports over the past year about problems with Essure, 90 percent of which involve attempts to remove the device. The Agency noted that the most recent message was received from lawyers representing patients suing Bayer.
Sourse: abcnews.go.com
