Seven weeks after her twins were born, a Washington woman decided she was done having children. But her obstetrician-gynecologist advised against the well-known tubal ligation, or having her “tubes tied,” which can be a complicated, risky procedure. Instead, the doctor suggested a relatively new method of permanent birth control: Essure®.
Essure claims to be the quickest, least invasive, and almost perfectly successful birth control method available, with a 99.74 percent success rate. Of course, the mother-of-8, like thousands of other Essure patients, couldn’t imagine anything better. According to a shocking profile recently published in The Washington Post, however, she would regret this decision for the rest of her life.
Within months, she noticed several unusual changes in her body, including tooth decay, hair loss, weight gain, severe fatigue, and heavy, irregular periods. That was until she missed a period altogether. Essure had failed to work; she was pregnant. Unfortunately, hers is only 1 of thousands of similar cases across the U.S.
Sounds Too Good to Be True… And It Is
Essure, a medical device approved in 2002, consists of 2 flexible, nickel-titanium coils. These are inserted into the fallopian tubes, where the immune system generates scar tissue and blocks the passage, so that nothing can reach the egg. No incisions, hormones, or anesthetics are needed. But what the procedure lacks in surgical complications, it makes up for in far worse problems down the line.
After allergic or autoimmune reactions to the metals in the device – which, in some cases, has migrated to or perforated other organs – many women have needed painful revision surgeries or hysterectomies to remove Essure.
Over 1,100 women became pregnant, and other women experienced stillbirths and miscarriages. Four cases resulted in death.
Doctors can only estimate how many women have had Essure implanted, although sales of more than 750,000 devices give a general idea. Over 16,000 women have reported symptoms and hospitalizations associated with Essure to the FDA. That said, even with so many injured women out there, many have struggled are still struggling to make their voices heard.
Who Is Responsible for This Mess?
In 2015, the Food and Drug Administration (FDA) issued a black box warning, recognizing “that some women are not receiving or understanding information regarding the risks and benefits of permanent, hysteroscopically-placed tubal implants that are intended for sterilization.”
Sure enough, doctors have continued to endorse Essure, and Bayer, Essure’s manufacturer, continues to push sales (even though data suggests its sales have dropped by 70 percent since 2010, according to the Post). Bayer, which acquired the original manufacturer, Conceptus, for $1.1 Billion in 2013, claims this drop in revenue is “nothing related to safety.”
While the black box warning was a huge victory for anti-Essure activists after a 14-year battle against Bayer, the FDA has the power to remove Essure from the market altogether, and it hasn’t. In fact, the agency hasn’t yet fully investigated the matter-at-hand. The question remains: Why did it approve Essure in the first place?
How Essure Slipped through the Cracks
When Conceptus submitted Essure for initial review, the FDA’s premarket approval standards for devices were far more ambiguous than those for drugs. Medical device makers simply had to display “reasonable assurance” of their products’ safety and efficacy.
Initial testing of Essure’s prototype found the device to be highly effective – provided it stayed put. Unfortunately, the device migrated in about 40 percent of cases. Worse still, this finding was after decades of research suggesting the dangers of metal implants. In later trials, Conceptus found evidence of serious adverse events. Gradually, the gravity of Essure’s risks became clear.
Yet, praising the device for offering “significant advantages over existing approved alternatives,” the FDA dismissed the need for randomized testing and actually fast-tracked Essure’s review process. “In determining safety and effectiveness, the FDA weighs any probable benefit to health from the use of the device against any potential risk of injury or illness from such use,” the agency said – the benefit being surgery evasion. But whether the device’s convenience still outweighs its risks is definitely up for debate.
“We all know the most rigorous data in clinical medicine is through randomization,” said Sanket Dhruva, a Yale University cardiologist interviewed by the Post, adding that at least 1,000 women would need to be followed for a minimum of 5 years with a control group to produce reliable data. Conceptus only studied trial participants for 1 year. “A short-term study might be okay if it’s a medication that you take for a week. But we’re talking about a device that’s going to be implanted in a million people for the rest of their lives.”
Patients Forced to Fight for Safety
Following a 2008 Supreme Court ruling designed to protect Class III devices, it became difficult, if not impossible, for women to sue pharma companies in state courts for devices that received premarket approval.
Fortunately, things are looking up. Some Essure lawsuits – claiming that women were not adequately informed about the device’s dangers (particularly its nickel, known to cause allergic reactions) – have gone forward. 5,200 women have petitioned to sue in 5 separate courts, prompting the 2017 Medical Device Safety Act, which, if passed, would eliminate Class III device protections. The FDA has also ordered Bayer to conduct another clinical investigation, this time involving more women and a control group over 3 years.
But until this happens, misrepresentation of Essure is still a problem, and the fact that safeguarding against the risks slipped doctors’ minds can only be attributed to financial gain. At the time of approval, Essure was regarded a game-changer in female sterilization. Naturally, patients and physicians jumped on the chance to adopt the technique, but for doctors, perhaps not for the right reasons. Private insurance reimburses $1,100 per device – almost double the amount for tubal ligation, says the Post.
Essure is clearly not the best option for all women, but doctors go ahead and recommended it anyway. Essure has proved itself, time after time, to have serious consequences, but Bayer still holds steadfast to its alleged benefits. How many more injuries is Bayer (and the FDA) prepared to accept before taking this product off the market?
The results of the next clinical trial are due in 2023, and the only hope is they will confirm what many believe already believe: That Essure is risky and ultimately dangerous. Hopefully it does not take another 6 years to tip the balance.