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Bayer announced Friday that it would cease the sale of its Essure birth control implant by the end of the year, hailing a long campaign led by advocates of health and safety. thousands of women to take the device out of the market.
had a troubled history. It has been the subject of about 16,000 lawsuits or claims filed by women who reported serious injuries, including a perforation of the uterus and fallopian tubes. Several deaths, including some infants, have also been attributed to the device or to complications of it.
Bayer said that its decision to stop the sales of the device was not related to litigation or security issues. use as women have chosen other options. Bayer has repeatedly denied that the implant is dangerous or has caused injury.
Women who had filed injury claims and defense groups, including one called Essure Problems that had 36,000 members on Facebook, had repeatedly demanded that the Food and Drug Administration. But the agency has declined.
In April, after meeting defenders of women, the F.D.A. Bayer had to limit sales to doctors' offices and medical practices that agreed to fully inform women about the risks of the product. At that time, the agency said that from 2002, the date on which Essure was approved, until the end of 2017, she had received nearly 27,000 reports from adverse events – although the FDA noted that some might have been duplicates.
Madris Tomes, a former F.D.A. "With side effects ranging from hair loss and tooth loss to chronic pain, severe bleeding, miscarriages and even death, the risk profile of benefits touted by Bayer simply does not jibe with the data that were pouring into the FDA "Ms. Tomes, who volunteered for a Essure Patient Advocacy Group
The Essure implant consists of two small coils made of a nickel alloy and d & # 39; A polyester-type fiber that is placed through the vagina into the fallopian tubes, and is designed to create an inflammatory response that causes scar tissue to form, blocking the tubes.The United States was the only country where the The device, considered a non-surgical sterilization implant, was still sold and Bayer had stopped selling it in England, Brazil, Canada, France and several other countries.
In 2016, the FDA ordo born the placement of a "black box warning" on the l & # 39; product packaging that warned of the risk of injury, including the fact that the implant could get into the body. abdomen and pelvic cavity, which may require surgical excision
. Scott Gottlieb, the F.D.A. The commissioner said Friday that appliance sales in the United States had dropped by about 70% since the agency ordered Bayer to conduct a post-market study on women using the drug. # 39; s device.
Dr. Gottlieb also stated that the F.D.A. would continue to evaluate reports filed on injuries related to Essure, as well as reports of surgeries needed to remove it.
Bayer accused "inaccurate and misleading advertising" as a key factor in the loss of sales. The company also said that American women were less interested in permanent contraception and instead relied on other contraceptive options, such as long-acting reversible contraceptives
"The Profile Benefits-risks of Essure have not changed ". "We continue to support the safety and efficacy of the product, which is demonstrated by a vast body of research."
Public health advocates have long been troubled by what they see as a lack of solid data on the safety of Essure. "Thousands of women have reported serious complications from Essure, and there has been no long-term, unbiased research to refute or confirm these reports," said Diana Zuckerman, president of the National Research Center. in health, who was a paid expert witness in one of the cases involving Essure plaintiffs against Bayer. "Both the FDA and the company is responsible for a situation where women could not make informed decisions."
The company said it would continue to recruit patients into the workforce. part of a postmarketing surveillance study and that she would work with the FDA
Steven Immergut, a spokesman for Bayer, said that in mid-April, about 16,800 plaintiffs had filed claims regarding Essure. Many lawsuits have been consolidated or merged from states across the country.
"We believe we have meritorious defenses and intend to continue vigorously defending Essure," said Mr. Immergut.
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