NEW YORK -- It's been marketed as a safe and very effective non-surgical contraceptive for women, manufactured by a company headquartered here in the Tri-state region. However, Essure, which is produced by Bayer U.S., has been attributed to severe health conditions in tens of thousands of women, some of whom are now suing the company over their prolonged ailments. On Friday, the company announced that it will stop selling the contraceptive device in the U.S.
The decision comes days before the worldwide release of a documentary film that focuses, in part, on the health problems that thousands of women claim have been caused by Essure.
"I had a medical device that broke, that set off a connective tissue disorder that started deteriorating my joints," says Angie Firmalino to a nurse at the beginning of the trailer to the film "The Bleeding Edge."https://www.youtube.com/watch?v=slmilObZl28. "Holy crap!" the nurse replies.
The documentary is about potentially hazardous medical devices, including Es-sure, a tiny, coiled device made of nickel and synthetic fibers that's designed to be inserted into a woman's Fallopian tubes to create scarring that ultimately blocks eggs from passing to the uterus.
Manufacturer Bayer has marketed Essure as being 99.83 percent effective in preventing contraception.
Some 30,000 women have reported symptoms like those that Bronx resident Lisa Saenz developed after receiving Essure implants ten years ago.
"You can see here, one of the devices is broken and curled," Saenz told PIX11 News in an interview in 2016, as she showed an x-ray of herself https://pix11.com/2016/01/07/essure-makers-defend-birth-control-device-even-as-thousands-of-women-say-theyre-getting-sick/.
Women have also reported severe rashes, intense abdominal pain, heavy bleeding and other symptoms associated with parts of Essure devices fracturing and migrating to other parts of the body.
In Saenz's case, she had to have a hysterectomy four years ago. On Friday, though, her reaction, which she gave in a FaceTime interview, was much more positive.
"[I'm] happy," Saenz said, "because we're saving hundreds of thousands of women from going through what we had to go through."
She's one of 16,000 women suing the manufacturer, Bayer U.S., of Whippany, New Jersey.
Bayer issued a statement on Friday, which said, in part, that its decision was based "on a decline in sales in recent years and the conclusion that the Essure business is no longer sustainable. The benefit-risk profile for Essure has not changed."
"We are working closely with the FDA and have planned a slow wind-down process to ensure patients and providers are appropriately supported," the statement continued. "This is voluntary discontinuation," a corporate spokesperson said, adding, "It is not a recall or safety situation."
The decline in sales is apparently due to scenes like one outside of Bayer's U.S. headquarters in New Jersey earlier this week https://www.wric.com/news/8-investigates/daylong-protest-of-essure-outside-bayer-hq/1308195146. There, a group of protesters showed the documentary "The Bleeding Edge" on a big screen.
The filmmaker, Kirby Dick, told PIX11 News that he felt that Bayer's decision was necessary, and that its timing was suspect. "I don't think Bayer wanted to put up with the negative publicity that would come out after our film came out," he said.
His film debuted at the TriBeCa Film Festival earlier this year. Its worldwide release is on July 27th on Netflix.
Bayer has said that it will "wind down" its sales of Essure through the end of the year. It ceased sales in Europe last year following thousands of complaints in that market as well. The U.S. is the last country in which Essure was sold.