Essure’s demise isn’t an end to medical device safety problems

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Michael Joyce is a writer-producer with and tweets as @mlmjoyce

Last Friday’s announcement that pharmaceutical giant Bayer will stop selling its controversial Essure birth control device understandably drew massive attention from both social and mainstream media.

Critics of the device — like Angie Firmalino who helped launch a social media campaign with the Facebook group “Essure Problems” — were able to claim a sober victory while emphasizing that “it took way too long.”

Bayer, on the other hand, minimized its defeat by claiming it was strictly a “business decision” and asserting it still believes the device is effective and safe. It claimed those women who still have the device implanted in their bodies can “confidently” rely on it.

That’s clearly a questionable proposition given that — according to the company’s last annual report —  over 15,000 patients have filed lawsuits against them, and thousands of women have reported complications to the FDA including: fallopian tube perforations, unintended pregnancies, autoimmune symptoms, and severe pain and bleeding that have resulted in hysterectomies.

But beyond these substantial harms there’s another reason we should never forget the 16-year-long Essure debacle: it’s a critical reminder (for journalists and consumers alike) that too many medical devices are allowed on the market with too little evidence that they are safe or effective.

And when that evidence finally does come it’s often too little, too late, for too many people.

A long journey

We first dug deep into Essure back in May of 2015 when Bayer issued a long overdue post-market report on the safety and effectiveness of what they marketed as a “non-surgical, non-hormonal option for permanent contraception.” (Essure is two flexible metal coils inserted into the fallopian tubes that are supposed to cause enough scarring to stop sperm from passing through to fertilize eggs.)

The Essure device

We felt the news release downplayed very real harms and failed to make it clear that two of the study authors were on the Bayer payroll. The release also soft-pedaled a 9-year delay between the study’s completion and its publication. Our review touched a nerve. Dozens of readers — most of them women — wrote in with stories of harm.

We revisited the escalating debacle in September of 2015 when the FDA started to hold hearings to determine if the then-13-year-old device should be restricted, have its labeling modified, and/or undergo further clinical trials. At that time we quoted experts who suggested the FDA was not being vigilant enough, raising the possibility that perhaps “[their] emphasis has been on getting drugs and devices on the market quickly, not on making sure they are safe.”

A few months later we warned that the 21st Century Cures Act (which eventually passed in December, 2016) would likely lead to even less scrutiny, and also cited a JAMA study which found that only about 1 in 10 post-market studies on the safety and efficacy of devices were completed within five years of FDA approval. We wrote:

“That’s a lot of time during which a bad device can be causing harm to unsuspecting patients.”

A growing hall of infamy

Essure is anything but an isolated example. It’s just the latest inductee into a growing hall of infamy. Here’s a small sampling of some we’ve covered:

All too often journalists cast the spotlight on drug safety and fail to scrutinize medical devices. But the approval process for devices is fraught with loopholes. Nearly 99% of these devices get on the market without their manufacturers providing any clinical data showing that they work. Even those devices that are studied rarely undergo randomized controlled trials, the gold standard in producing unbiased results.

This is such a big problem, and so often missed by journalists writing about new devices that are rolled out to much fanfare, that we’ve written this primer:

Why ‘approved’ medical devices in the U.S. may not be safe or effective

And for those who want to dig even deeper into this area, we can’t recommend this book by Jeanne Lenzer highly enough:

The Danger Within Us: America’s Untested, Unregulated Medical Device Industry and One Man’s Battle to Survive It

Don’t forget Essure. Remember that even with a well-organized campaign against it, and thousands of harms brought to the FDA’s attention, it still took 16 years for it be taken off the market — and even then without the manufacturer or the FDA acknowledging the scope of the device’s safety problems.

The lessons here? The Essure debacle is only the tip of the iceberg when it comes to the safety problems of medical devices. An informed and watchful public is needed to bring these problems to light and bring change to this industry.

That awareness may get a huge boost this Friday, July 27th, when Netflix premieres the documentary ‘The Bleeding Edge‘ by documentarians Amy Ziering and Kirby Dick. The film focuses on the dysfunction and potential harms of the $400 billion medical device industry and includes, amongst several patient profiles, a woman badly injured from an Essure device.

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Comments (1)

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Lisa Leger

July 31, 2018 at 3:02 pm

Permit me to emphasize the misogyny inherent in gynecological procedures that assume the normal female body is problematic to begin with and needs to be tamed by technology.