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Pharmaceutical Giant Bayer said Friday that it will halt sales of its controversial Essure birth-control device in the United States at the end of the year, bringing to a close a protracted battle over an implant that causes serious blemishes, including persistent pain and perforation of the uterus and fallopian tubes.
The company said: "The business decision is precipitous declines in sales in recent years. It is in a statement that it stands by the safety and effectiveness of the device and that it is currently in place.
The United States is the last country where Essure is being sold. Last September, citing "commercial reasons," Bayer announced it was ending sales outside the United States.
Essure, which is designed to cause sterilization, consists of two-inch-long, flexible coils made in part from an alloy of nickel and titanium. In a procedure that takes about 10 minutes, a doctor inserts the coils through the vagina and cervix and into the fallopian tubes, which carry eggs from the ovaries to the uterus. Over the course of three months, creating a barrier that keeps sperm from reaching the eggs.
In recent years, thousands of women reported complications including autoimmune disorders, unintended pregnancies, and the migration of the coils into the pelvis or abdomen. Many said the problems were so severe that they had the devices surgically removed. More than 16,000 patients, the company said earlier this year.
Angie Firmalino, one of the leaders of the fight against the device, on Friday said she was "blown away" by Bayer's announcement. "It was way too long, but we won," said the 46-year-old mail carrier from Tannersville, New York.
Firmalino said she had the device inserted in 2009 and almost immediately began having bread and bleeding; she eventually learned that the coils had migrated to her uterus and had a hysterectomy. In 2011, she started the Facebook group "Essure Problems," which has waged a social media campaign against the device and pressed the Food and Drug Administration to ban it. The group has 37,000 members.
Bayer said in the United States 40 percent in recent years. On Friday, the company has several factors: a decline in the number of women using permanent contraception; Contraceptive methods that are reversible, such as intrauterine devices, and "inaccurate and misleading publicity" about the implant.
The device, which was approved by the FDA in 2002, was originally introduced as an alternative to tubal ligation, commonly called having one's "tubes tied." It was developed by Conceptus Inc., a California medical products manufacturer that Bayer acquired in 2013.
As reports of complications, the FDA has consistently maintained, as Bayer has, that the device's benefits outweigh its risks. But the agency also has serious problems associated with contraceptive and controlled up additional warnings and safety studies.
In 2016, for example, the FDA required Bayer to add a "black box" – the agency's most serious warning – to the product's label. And it directed Bayer to create a three-page checklist for patients to discuss potential problems with patients before implantation.
Earlier this year, patient advocates told Scott Gottlieb, the commissioner of the FDA, that many women still have not been adequately warned about the risks. In April, the agency imposed a unique restriction on the product:
On Friday, in a statement, Gottlieb tried to reassure women who are using drugs that they can continue to do so; those who think they are having symptoms caused by the device should talk to their doctors. "Device removal has its own risks," he added.
Some FDAs have long been critical of the FDA, saying it approved the device based on an inadequate study.
"The FDA should have required a moratorium on sales and demanded that it be submitted to a much more timely fashion," said Diana Zuckerman, president of the National Center for Health Research, a nonprofit think tank.
An estimated 750,000 devices have been sold, mostly in the United States.
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