Bayer to halt sales of controversial Essure birth-control implants in the U.S., its last market
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 thousands of women blame for serious health problems, including persistent pain and perforations of the uterus and fallopian tubes.
In a statement, the company said, “This decision is based on a decline in U.S. sales of Essure in recent years and the conclusion that the Essure business is no longer sustainable.” It said it stands by the safety and effectiveness of the device, and added that women who currently have Essure in place can continue to “confidently” rely on it.
The United States is the last country in which 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 three months, scar tissue is supposed to form around the coils, creating a barrier that keeps sperm from reaching the eggs.
In recent years, thousands of women have reported complications, including autoimmune problems, unintended pregnancies and the migration of the coils into the pelvis or abdomen. Many women said the problems were so severe that they had to have the devices surgically removed. Bayer is facing numerous lawsuits related to the device.
Bayer said Essure sales in the United States have plummeted by 40% a year in recent years. On Friday, the company attributed the decrease to several factors: a decline in the number of women using permanent contraception; increased reliance on long-acting contraceptives that are reversible, such as intrauterine devices; and “inaccurate and misleading publicity.”
The device, which was approved by the FDA in 2002, was initially hailed as the only nonsurgical alternative to tubal ligation, commonly called having one’s “tubes tied.” The device was developed by Conceptus Inc., a California medical products manufacturer that Bayer acquired in 2013.
Over the past several years, Essure critics have waged a social media campaign against the device. Members of an Essure Problems group on Facebook, which has 37,000 members, have pressed the Food and Drug Administration to ban the implant.
The FDA, in response, has maintained that the benefits of the device outweigh the risks when the implant is used correctly. But it also has ordered a series of warnings and safety studies.
In 2016, for example, the agency required Bayer to add a “black box” — the agency’s most serious warning — to the product label. It also directed Bayer to create a three-page checklist for doctors to use in discussing potential problems with patients before implantation.
In February, Essure critics met with Scott Gottlieb, commissioner of the FDA, and complained that many women still were not being adequately warned about the risks. Two months later, the agency imposed a unique restriction on the product: It limited sales to doctors who guaranteed that women were being told about the device’s risks, and made Bayer responsible for implementing the requirement.
Estimates are that the devices have been used by more than 750,000 women worldwide. The vast majority of sales have been in the United States.
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