Bayer introduced on Friday that it could discontinue gross sales of its Essure contraception implant by the tip of the 12 months, bowing to a prolonged marketing campaign by well being advocates and hundreds of girls to get the system off the market.
The implant has had a troubled historical past. It has been the topic of an estimated 16,000 lawsuits or claims filed by ladies who reported extreme accidents, together with perforation of the uterus and the fallopian tubes. Several deaths, together with of some infants, have additionally been attributed to the system or to problems from it.
Bayer stated its choice to halt gross sales of the system was not associated to the litigation or questions of safety, however to a decline in use as ladies selected different choices. Bayer has repeatedly denied that the implant is harmful or prompted accidents.
Women who had filed harm claims and advocacy teams, together with one referred to as Essure Problems that had 36,000 members on Facebook, had repeatedly demanded that the Food and Drug Administration ban the system. But the company declined.
In April, after assembly with advocates for the ladies, the F.D.A. required Bayer to restrict gross sales to docs’ places of work and medical practices that agreed to totally inform ladies in regards to the product’s dangers. At that point, the company stated that from 2002, when Essure was permitted, via the tip of 2017, it had acquired almost 27,000 reviews of adversarial occasions — though the F.D.A. famous that some may need been duplicates.
Madris Tomes, a former F.D.A. medical system official who runs an organization that analyzes adversarial occasion information, places the determine nearer to 30,000.
“With side effects ranging from hair loss and tooth loss to chronic pain, severe bleeding, miscarriages and even death, the benefit risk profile touted by Bayer simply didn’t jibe with the data that was pouring into the F.D.A. from both patients and physicians,” stated Ms. Tomes, who has achieved professional bono work for an Essure affected person advocacy group.
The Essure implant consists of two small coils made from a nickel alloy and a polytester-like fiber. It is positioned via the vagina into the fallopian tubes, and is designed to create an inflammatory response that causes scar tissue to kind, blocking the tubes. The United States was the one nation the place the system, thought of a nonsurgical sterilization implant, was nonetheless being offered. Bayer had stopped promoting it in England, Brazil, Canada, France and several other different nations.
In 2016, the F.D.A. ordered placement of a “black box warning” on the product bundle that warned of the harm threat, together with that the implant may journey into the stomach and pelvic cavity, probably requiring surgical removing.
Dr. Scott Gottlieb, the F.D.A. commissioner, stated Friday that gross sales of the system within the United States had declined by about 70 % because the company ordered Bayer to conduct a post-market research on ladies utilizing the system and to put the boxed warning and affected person choice guidelines on the labeling.
Bayer blamed “inaccurate and misleading publicity” as a key consider gross sales loss. The firm additionally stated that American ladies have been changing into much less fascinated about everlasting contraception, and as an alternative have been relying extra on different contraception choices, like long-acting reversible contraceptives.
“The benefit-risk profile of Essure has not changed,” the corporate stated, “and we continue to stand behind the product’s safety and efficacy, which are demonstrated by an extensive body of research.”
Public well being advocates have lengthy been troubled by what they see as an absence of stable information on Essure’s security and effectiveness.
“Thousands of women have reported serious complications from Essure, and there has been no unbiased long-term research to refute or confirm those reports,” stated Diana Zuckerman, president of the National Center for Health Research, who has been a paid skilled witness in one of many instances involving Essure plaintiffs in opposition to Bayer. “Both the F.D.A. and the company are responsible for a situation where women could not make informed decisions.”
The firm stated it could proceed to enroll sufferers in a postmarket surveillance research and can work with the F.D.A. to make sure acceptable comply with up.
Steven Immergut, a Bayer spokesman, stated that as of mid-April, there have been about 16,800 plaintiffs who’ve filed claims concerning Essure. Many of the lawsuits have been consolidated or merged from states throughout the nation. “We believe we have meritorious defenses and intend to continue to vigorously defend Essure,” he stated.