Finally, after years of protest and over 16,000 product liability lawsuits, medical device giant Bayer has decided to withdraw its Essure birth control implant from the US market. After December 31, 2018, Essure will no longer be available anywhere in the world. Advocates around the globe has hailed the market withdrawal as a resounding victory.
Bayer Pulls Birth Control Implant From American Market
Bayer’s announcement, dubbed by the company as a “business decision,” comes in the wake of some very bad press.
Today, July 30, 2018, Netflix released its new documentary, The Bleeding Edge, which chronicles problems in the medical device industry and takes a special interest in the severe injuries to which Essure has been linked.
In April 2018, the US Food & Drug Administration also took a “unique” position on Essure, requiring doctors across the country to inform their patients of Essure’s risks and side effects with the threat of criminal proceedings for physicians who failed to do so. It is believed to be the first time in American history when doctors faced such criminal penalties over a medical device.
And in Spain, the country’s version of the Supreme Court has opened a criminal inquiry of its own into Bayer’s conduct around Essure, noting the “possible existence of a criminal offense,”El País reports. No word yet on whether or not the criminal investigation has turned up evidence of wrongdoing.
American Sales Fall Precipitously
It was a particularly bad week for Bayer’s controversial birth control device. Product liability lawsuits against the manufacturer continue to proceed in California, Pennsylvania and other states, despite Bayer’s vigorous efforts to have the cases dismissed.
A week-long protest was held in front of Bayer’s headquarters, where advocates from Essure Problems joined forces to demand change and stage a screening of The Bleeding Edge for interested Bayer employees.
While Bayer has as of yet refused to release official statistics on Essure usage, the company says that at least 750,000 units of the controversial medical device have been purchased.
Widespread public pressure led the company to pull its contraceptive implant from the world market last September. At the time, Bayer said that market demand for the device had fallen so low that carrying the implant at all was no longer a viable commercial option. But the United States remained a lucrative market, so Essure stayed in circulation here with additional FDA warnings and restrictions. Now, we know the American market has dried up as well.
Bayer announced its decision to pull Essure from US shelves on Friday, July 20, 2018. In a press announcement, Bayer spokesperson Courtney Mallon called the move a “voluntary discontinuation,” according to CBS Boston.
A gynecologist for the company cited a “decline in sales” to explain the “business decision.” She says the company has no plans to re-design a safer version of Essure, Insurance Journal reports.
Mallon reiterated that Bayer’s withdrawal is not being made for safety reasons, saying the device’s benefit-risk profile “has not changed.” Bayer is “working closely with the FDA and have planned a slow wind-down process to ensure patients and providers are appropriately supported,” she said. What that “wind-down process” looks like in practice is anyone’s guess.
“We Have Finally Won”
Women who advocated against Essure are celebrating Bayer’s decision as a huge victory. “We have won. We have finally won,” says Angie Firmalino, who started the grassroots Essure Problems group in 2011 to urge a recall of the device. “Seven long years of fighting to get Essure removed from the United States market has finally paid off,” Firmalino continued.
FDA Commissioner Scott Gottlieb, in a statement provided after Bayer’s decision was announced, said his agency would continue to work with Bayer to conduct a study of Essure’s long-term side effects, even though Bayer would no longer be able to reach the pre-determined patient threshold of 2,000 patients. The FDA will also continue to monitor side effect reports, Gottlieb said.