Bayer announced Friday that it would discontinue the sale of its Essure implant by the end of the year after a lengthy campaign by health attorneys and thousands of women took the device off the market
had a troubled history. It is the subject of an estimated 16,000 complaints or complaints from women who have reported serious injuries, including the perforation of the uterus and fallopian tubes. Several deaths, including a few infants, have also been attributed to the device or complications thereof.
Bayer said his decision to stop selling the device was not due to litigation or security issues, but to a decline in the use of women's options. Bayer has repeatedly denied that the implant is dangerous or causes injury.
In April, after meeting with advocates for women, the F.D.A. Www.cosmetic-business.com//showarti…p?art_id=736 Bayer required Bayer to limit sales to medical practices and medical practices who agreed to provide women with comprehensive information about the risks of the product. Englisch: www.cosmetic-business.com/en/showar…p?art_id=744 At the time, the agency said that from 2002, when Essure was approved, nearly 27,000 adverse event reports were received by the end of 2017 – though the FDA noted that there could be some duplicates.
Madris Tomes, a former F.D.A. A medical device company running a company that analyzes adverse event data brings the number closer to 30,000.
"With side effects ranging from hair loss and tooth loss to chronic pain, heavy bleeding, miscarriages and even death, Bayer has simply not advertised the data flowing into the FDA from both patients and physicians," said Ms. Tomes who has done pro bono work for an Essure patient advocacy group.
The Essure implant consists of two small coils of a nickel alloy and a polyester fiber. It is placed through the vagina into the fallopian tubes and is said to cause an inflammatory reaction that results in the formation of scar tissue that blocks the tubes. The United States was the only country where the device, considered a non-surgical sterilization implant, was still sold. Bayer had stopped selling it in England, Brazil, Canada, France and some other countries.
In 2016, the F.D.A. ordered placement of a "black box warning" on the product packaging that warned of the risk of injury, including the fact that the implant could get into the abdomen and pelvic cavity and may need to be surgically removed.
Dr. Scott Gottlieb, the F.D.A. Www.mjfriendship.de/de/index.php?op…80&Itemid=58 The commissioner said on Friday that the sales of the product in the USA had decreased about 70 per cent, since the agency commissioned Bayer to carry out a market study Women with the device and set the checklist with warning and patient decision on the label.
Bayer blamed "inaccurate and misleading advertising" for a key factor in losing sales. The company also said that American women are less interested in permanent contraception and instead focus more on other birth control options such as long-acting reversible contraceptives.
"Essure's risk-benefit profile has not changed," the company said, "and we remain committed to the product's safety and efficacy, as evidenced by extensive research."
Public health advocates have long been suffering from the lack of solid data on the safety of Essure
"Thousands of women have reported serious complications from Essure and there has been no unbiased long-term research to refute or confirm these reports" said Diana Zuckerman, President of the National Center for Health Research, who was a paid expert in one of the cases where Essure plaintiffs v Bayer. "Both the F.D.A. and the company are responsible for a situation where women could not make informed decisions."
The company said it would continue to enroll patients in a postal market surveillance study and collaborate with the F.D.A. (19659017) Steven Immergut, a Bayer spokesman, said there were around 16,800 plaintiffs in mid-April who had claims against Essure. Many of the lawsuits have been consolidated or brought together from states across the country.
"We believe that we have a meritorious defense and intend to continue vigorously defending Essure," said Immergut.