In a personal letter sure to infuriate women’s health advocates, Dr. Scott Gottlieb, head of the US Food & Drug Administration, has provided an “update” on the federal agency’s efforts to regulate Essure, a permanent birth control implant linked to severe side effects and invasive removal procedures.
FDA Continues To Back Essure, Despite Recall Movement
In one sense, it sounds like the FDA isn’t doing much of anything. While Gottlieb pays lip service to the private meeting he held on February 7, 2018, in which leaders from the Essure Problems group argued that the device should be pulled from the market, there’s no indication that the FDA chief plans to take their positions seriously.
“As a physician,” Gottlieb writes, “I know that patients are uniquely positioned to provide feedback to the FDA about their experiences with currently available medical products, and I appreciated the thoughtful discussion.” That may be true, but the pleas of thousands of women obviously haven’t changed Gottlieb’s mind yet.
Is FDA Support Crumbling?
At the same time, Essure’s stock at the FDA could be decreasing. Near the end of his letter, Gottlieb trots out this familiar line: “the FDA continues to believe that Essure may be appropriate for some women based on our current information.” That’s far from a resounding endorsement.
“May” and “some” aren’t words that give a patient confidence about their medical options; those are words people use to hedge their bets, especially when the following phrase reads, “the agency also recognizes that serious problems have been associated with its use.”
12,000 New Side Effect Reports In 2017
The FDA received around 12,000 new reports of Essure side effects in 2017, Gottlieb says, “the majority [of which] were sent […] in the last quarter of the year.” Gottlieb ascribes this uptick in reporting to “litigation against the product sponsor,” Bayer, the manufacturer of Essure. Bayer currently faces over 10,000 Essure lawsuits. And Gottlieb says that most of the new side effect reports, 90% of which mention the potential for invasive device removal procedures, have come from plaintiffs’ attorneys.
At the moment, the FDA is sifting through these new reports to figure out which ones are actually new and which ones may have been reported at an earlier time. “The FDA will be following up on many of these individual reports to gather this additional information,” Gottlieb writes.
In a statement provided to Reuters, a Bayer spokesperson said the wave of new Essure reports is nothing to get worked about. “In fact,” spokesperson Courtney Mallon wrote in an email, “the number of Essure medical device reports that are not related to the litigation is declining, while litigation-related medical device reports are dramatically increasing.” Of course, that doesn’t really prove anything. Just because some, or many, of the new reports come from women who have filed lawsuits, doesn’t mean they shouldn’t be trusted.
16 Years On, Essure Advocates Are Still Waiting For Action
The core message of Gottlieb’s memo, though, is pretty clear: the FDA is going to kick this can down the road for as long as it can.
The word “continue” appears 7 times: “the agency has continued to monitor the product’s safety,” “we continue to review medical device reports,” “the FDA will use the new information to continue to inform our assessment,” and so on.
Essure was approved in 2002, 16 years ago. We all understand that science is a long game, and that medical devices and their interactions with a patient’s body are extraordinarily complex. But it doesn’t usually take this long to get a bad medical device off the market.
How Long Do Recalls Usually Take?
Of the 32 device recalls listed for 2017 on the FDA’s website, the vast majority were issued within four years of the product’s initial distribution date. And, by and large, these were voluntary recalls, withdrawals initiated by medical device manufacturers who noticed a problem and acted on it.
In contrast, the FDA has taken 16 years to evaluate the safety and benefits of Essure without drawing any real conclusions.
It’s not as if the FDA has done nothing. As Gottlieb notes, the agency has taken several important steps to regulate the use of Essure, including a black box warning on product labeling and a “Patient Decision Checklist” to help women consider their contraceptive choices in more detail.
In addition, Bayer has been ordered to conduct a new postmarketing study on Essure’s safety risks in real-world practice, but critics, including several Congresswomen have questioned the company’s commitment to this program.
Why Is Essure Still Available In The US?
All of this is made stranger by the fact that, today, America is the only place where a woman can still receive Essure implants. In September 2017, Bayer announced a nearly-global withdrawal for the medical device, halting sales and distribution across the world, except in the United States.
We can assume that Bayer continues to see a profit opportunity in America but, given the extraordinary public outcry over Essure-linked injuries, it’s hard to believe that Bayer expects to make any more money off of these devices. That’s doubly true when you consider that defending itself against Essure lawsuits cost Bayer around $413 million in 2017 alone, as reported by Modern Healthcare.