Bayer will no longer sell Essure implants outside of the United States, according to a major announcement delivered on Monday, September 18, 2017.
The move is being considered by many public health advocates as an extraordinary victory for women around the globe. Thousands of patients say Essure causes life-altering side effects, including debilitating pain. Many have been forced to undergo full hysterectomy procedures to have the devices removed. Over 15,000 complaints have been submitted to the US Food & Drug Administration.
“Continuous Decline In Demand”
In a press release cited by CBS News, Bayer said that “commercial reasons” had convinced the healthcare conglomerate’s executives to end all distribution, sales and marketing of the contraceptive implant, except those activities occurring in the US. “The decision,” says Bayer spokesperson Courtney Mallon, “is unrelated to product safety or efficacy.”
“A continuous decline in demand,” the company writes, has created “an environment unfavorable to [Essure’s] prescription.” Here, Bayer undoubtedly refers to the massive campaign, led by US-based group Essure Problems, that saw hundreds of thousands of women band together against the implant.
15,000 Side Effect Reports
Essure is advertised as a permanent form of female sterilization that does not require surgery. Thus Bayer positioned the implant, a small metal coil inserted into both fallopian tubes to block the release of eggs, as the world’s first reliable alternative to tubal ligation.
But almost as soon as the device was released in 2002, women began complaining of severe side effects. Eventually, the US Food & Drug Administration received nearly 15,000 reports from patients and health care providers that detailed shocking levels of pain, abnormal menstruation and even autoimmune disorders. In her statement, Bayer spokesperson Courtney Mallon called recent side effect reporting “inaccurate and biased.”
Protests & Lawsuits Drive Essure’s “Commercial” Downfall
Advocacy groups cropped up across the world, with branches in South Africa, France, Finland and a dozen other countries. Members were joined together by their tragic personal experiences and a shared desire to have Essure recalled globally. Astoundingly, the grassroots campaign worked, helped along in no small part by the thousands of product liability lawsuits filed against Bayer over the last four years.
Today, nearly 6,000 women have sued Bayer over its birth control implant. While these lawsuits have faced significant hurdles, due in no small part to Essure’s premarket FDA approval, they’ve also cost Bayer a lot of money. An article at Modern Healthcare reported that, in 2016 alone, the Essure litigation cost Bayer around $413 million in losses. In fact, the company told shareholders in its 2016 Annual Report that, when combined with a second litigation, defending against Essure lawsuits would “exceed […] available insurance coverage.”
Market Withdrawals Pile Up
Protests across the world broke the story of Essure’s alleged side effects to the general public. Women, it now seems clear, just didn’t want to chance the procedure. Doctors stopped ordering the implants and a number of national governments took notice. Brazil issued a unilateral recall for the device. Guided by health regulators in Ireland, the European Union put a temporary hold on all Essure implants to allow for more safety analysis. France and Ukraine recalled the devices entirely as a result.
Soon, Bayer just wasn’t making enough money to continue offering its product. In a series of abrupt proclamations, the company began pulling out of smaller markets. Essure sales were ended in Finland and the Netherlands. Canada, the United Kingdom and Australia, all slightly-larger markets, came next. Australia’s regulatory body, the Therapeutic Goods Administration, recalled the device shortly after.
Why Haven’t Essure Sales Ended In The United States?
While Bayer’s new announcement will certainly be met with enthusiasm, it can’t help but leave many American patients wondering why Essure sales in the United States were left out.
The US is, and has always been, Bayer’s largest market for Essure. In its September 18 press release, the company suggested that patients outside the US simply lacked an “interest in permanent birth control.” The implication, of course, is that women in the United States remain “interested” in permanent contraceptive options. But the country’s unique regulatory reaction to Essure is also important to note. Although health regulators in many European nations have expressed serious concern over the apparent rate of side effects, the FDA still believes the device’s benefits outweigh its risks, Medscape reports.
Women Gather To Demand Medical Device Safety Act
Meanwhile, women continue to protest outside Congress, calling on lawmakers to pass the Medical Device Safety Act, a bill that would allow patients to sue manufacturers over Class III medical devices.
On Monday, September 25, one week after Bayer’s landmark announcement, a group of Essure Problems members converged on Washington, D.C. to advocate for the bill, which is sponsored by Pennsylvania State Representative Brian Fitzpatrick.
“I don’t want to see anybody else go through this,” Shannon Walsh told reporters at ABC8. Walsh says she developed a chronic rash, pain and cognitive deficiencies after receiving Essure implants. Her symptoms were so bad that she was forced to leave her job at the FBI. And, like numerous other women, her only choice to have the implants removed was a full hysterectomy.
Why Bayer Is Granted Legal Immunity
Yet due to a clash between federal and state laws, Walsh’s chances of winning compensation in court are severely diminished.
Class III devices, defined as high risk, are currently subjected to the FDA’s most stringent approval process. In exchange for the expense of pushing a device through this costly process, medical device manufacturers are granted a degree of immunity from product liability lawsuits, which are usually based in tenets of state law.
This doctrine has become a recurring issue for women who want to file Essure lawsuits against Bayer, although state court judges in California and Pennsylvania have handed down major decisions allowing plaintiffs claims to move forward. The legal terrain needs to change, says Angie Firmalino, who started the Essure Problems Facebook group that now includes over 35,000 members.
FDA Stands Behind Benefit-Risk Profile
FDA inaction, advocates say, is the crux of the problem.”Whoever said, ‘Yes, we can put this on the market,’ ” Keisha Carney told The Investigative Fund, “sometimes I wish they would have to endure what we’ve gone through.” Carney underwent a hysterectomy to have her Essure implants removed, after which she says her side effects disappeared.
In a statement released to ABC8, the federal agency wrote:
“The FDA is aware that Bayer is no longer marketing Essure in any countries except for the U.S. The company has informed us that they remain committed to fulfilling the obligations outlined in the 522 postmarket study that the FDA issued last year.
The FDA has taken several steps to ensure the ongoing evaluation of Essure’s safety and efficacy, as well as to educate healthcare professionals and women about the potential risks of using the device. After a careful review of available information, the FDA last year approved required changes to the Essure labeling, including a boxed warning and a Patient Decision Checklist to help better ensure women receive and understand information regarding the benefits and risks of this type of device.
The FDA’s latest recommendations on Essure remain in place. The FDA strongly encourages health care providers to use the Patient Decision Checklist in discussions with patients considering Essure. The FDA is working with professional medical societies, patient advocacy groups and women’s health organizations to ensure that risk information about these devices is disseminated to patients considering Essure or other sterilization options.”
Health Experts Think US Withdrawal Is Coming
Some safety experts, however, say Bayer is likely to pull the plug on Essure in America, too. Erik Gordon, a professor of business at the University of Michigan, told Modern Healthcare, “I think […] that the product isn’t important enough commercially for Bayer for it to continue throwing money at lawyers to keep on the market.” Art Sedrakyan agrees. The Cornell health care policy professor “said he wouldn’t be surprised if Bayer voluntarily stops selling Essure” in the US.
In passing, Sedrakyan also noted evidence to suggest that, out of a fear that they would be pulled into the litigation, doctors had become hesitant to recommend the birth control implant. At least one report substantiates that claim. The Investigative Fund learned from athenahealth, a company that creates medical billing software, that Essure sales logged with the service have fallen by 70% since 2010.
European Regulators Pull The Plug Faster
This brings us back to the difference in regulatory cultures. The US Food & Drug Administration is usually slow to force recalls onto device manufacturers. As the Essure controversy began to grow, the FDA ultimately decided to place a “black box warning” on the device’s labeling. A “patient decision checklist” was also created to help guide doctor-patient conversations about Essure’s risks and benefits. But the agency stopped far short of recalling the implant completely. Health agencies in Europe, on the other hand, are generally more willing to pull a dangerous product off the market of their own accord.
Long-Term Risk Research Is Urgently Needed
Whether or not Bayer ends Essure sales in the US is still an open question. In the meantime, Diana Zuckerman, president at the National Center for Health Research, a non-profit health policy think tank in Washington, D.C., says, “what’s particularly important to patients who do have Essure is that there be research as soon as possible to show them what the risks and the benefits are over the long term regardless of what country is still selling Essure.”
A study that fits Zuckerman’s description is ongoing. Mandated by the FDA, a seven-year study involving 2,800 women was started last year. The results will be available in 2023. A statement from the FDA says that, despite Bayer’s decision to end non-US sales, the agency’s study of Essure risks will continue as planned.