16 August 2018

Examining the FDA’s Role in Bayer’s Essure Implant Scandal

essure fda approval label

The Netflix documentary, The Bleeding Edge, puts a spotlight on the FDA’s role in the Essure scandal, among other controversial medical devices. The overarching theme in this documentary is that the system the FDA uses to regulate medical devices is fundamentally flawed. There’s no shortage of legal or clinical witnesses describing how, when and where the FDA fell short and failed patients like the thousands of women with Essure implants.

Essure Received FDA Approval

However, the primary purpose of the FDA is to protect consumers from a variety of clinical risks, including medical devices. It’s worth noting that women who’ve had the FDA-approved Essure implant have a sterilization rate seven times higher than those who received traditional tube ligation. The copy of the 2002 FDA premarket approval hearing for Essure shown in the documentary is particularly unsettling. The video was originally obtained by advocacy group Essure Problems.

During the PMA hearing, members of the FDA panel are actually seen joking and carrying on about the potential consequences of exposing future patients to serious health risks. Members on the panel approved the permanent birth control despite a number of questions and data queries left unanswered by the manufacturer’s representatives.

The FDA’s Flawed System for Medical Devices

According to David Kessler, FDA Commissioner from 1990 to 1997, the FDA is organized by different centers for food, biologics, drugs and medical devices, but the system built for medical devices simply doesn’t work. The former commissioner also noted that the FDA has a a system for reporting complications, but it’s only a voluntary system so there’s been massive under-reporting.

Experts estimate that just 3 or 4 percent of all adverse events are actually reported to the FDA. The only parties required to report adverse events are the medical device companies. A Professor of Surgery and Health Policy at John Hopkins School of Medicine describes the issue as the massive adoption of new technology with no enough evaluation of the potential outcomes.

One of the major issues with how the FDA regulates medical devices is the 510(K) provision. This provision allows new medical devices to skip the PMA process as long as the manufacturer demonstrates that it is substantially equivalent to another predicate device already available in US markets. Experts say you then end up with a daisy-chain of approvals with new devices based on designs from older ones have already been recalled because they were unsafe.

The 501(K) was originally signed as a loophole seldom used as an exception, but it soon became the rule as a standard business practice. Kessler says that the majority of the medical devices today are approved through the 501(K) provision. According to The Bleeding Edge, around 98 percent of all medical devices are approved under 501(K) and only 2 percent go through the PMA process.

Even if the device has been predicate device has been recalled because it’s unsafe, the manufacturer can still use it to get a new medical device approved under the 501(K) provision. One Stanford physician says consumers can no longer rely on the FDA to properly regulate new medical devices. Even as Bayer announced it’d be pulling Essure from US markets, the company claims that the safety profile for implant remained positive and unchanged.

FDA and Bayer Respond to The Bleeding Edge

According to Bayer, the Netflix documentary portrayal of Essure was misleading and inaccurate. The FDA responded to the Bayer announcement by maintaining that evaluating the postmarket safety of Essure remained a top priority at the agency. The directors of the gripping Netflix documentary say flaws in the regulatory system that unnecessarily puts patients at risk is what inspired them to make The Bleeding Edge.

The directors claim that the FDA allowing 98 percent of the devices to be approved without human studies basically makes unsuspecting consumers the guinea pigs for new treatments. It’s worth noting that while Essure breezed through the PMA process, it was rated by the FDA as a Class III device, posing the highest risk to consumers. It’s also worth mentioning that the US markets was the last place in the world Essure was still permitted to be sold or distributed.

The History Between the FDA and Essure

Long before the FDA was compelled to put restriction on Essure, the rest of the regulatory authorities worldwide had already banned the controversial implant in their respective jurisdictions. In response to the documentary, the FDA notes that while various processes are used to vet each product, generally speaking, not all the risks and benefits are understood before a product reaches market. The agency claims that the true risk-benefit profile can’t be understood until the product is used routinely by clinics.

In April 2018, the FDA placed a restriction on the sale and distribution of Essure. The FDA and Bayer expect the postmarket analysis obligations to be fulfilled even though Essure will be pulled from US markets by 2019. The agency claims it began taking actions to better evaluate the risks and benefits and patients concerns once the influx of adverse reports began coming in.

Before the sales restriction and postmarket surveillance requirements, the FDA also imposed boxed-warning and patient checklist requirements. These actions were designed to better inform patients about the risks associated with the controversial implant. According to the FDA, by Dec. 31, 2017, the agency had received over 26,7000 adverse event reports about Essure. In its own response to the documentary, Bayer points out that the FDA never changed its determination that the benefits of Essure outweigh any of the potential risks.

Conflicts of Interest from the Top

While FDA Commissioner Gottlieb’s statements and actions against Essure are convincing, his history with the permanent birth control implant is worth mentioning. His company, New Enterprise Associates, actually funded the development of Essure. For his first two years as commissioner, he agreed to recuse himself from any decisions concerning companies he had been previously involved with. One of the first things he did was hire the FDA’s new lead attorney.

Shockingly, the new lead attorney Gottlieb’s hired formerly worked as a representative for Bayer against any patients who were harmed by their medical devices. The current climate and inclination to cut regulations bodes well in some industries, but not for regulating agencies like the FDA that are charged with protecting consumers and providing oversight for medical devices like Essure.

According to the founder of Essure Problems, Bayer didn’t have any incentive to remove the implant from US markets because no one was holding the manufacturer accountable. The private Facebook group had been fighting for the longest, but under the watch of the FDA, the only market still allowing the sale and distribution of Essure in 2018 was the US.

Thankfully, despite inaction from the FDA, advocacy groups like Essure Problems refused to stop until Essure was taken off the market.


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