Thousands of women sue Bayer over medical issues using Bayer's Essure
Drug and devicemakers must weigh the impact of litigation and public relations battle when allegations of patient harm arise
After giving birth to her third daughter in 2013, Rina Kellogg was done having children. She wanted to have her tubes tied, but her OB-GYN suggested she get a sterilization implant called Essure.
"She said it was the latest and greatest technology, and that it was like putting a stent in your heart," said Kellogg, a 36-year-old living in Spring, Texas. "I trusted her and I went ahead and did the procedure."
Essure consists of two sets of tiny coils-one of stainless steel, wound with polyethylene terephthalate polyester fibers, nestled in a larger nickel-titanium coil-that are implanted in a woman's fallopian tubes. Scar tissue is supposed to form around them, securing the coils and blocking the tubes so that eggs cannot be fertilized.
After the implantation in August 2014, Kellogg was in pain. But she assumed her body needed time to adjust. By Christmas, however, she was in agony with cramping and profuse bleeding. During a follow-up visit, Kellogg's doctor dismissed her symptoms as results of stopping hormonal birth control. She also told Kellogg, 33 at the time, that she was "getting older."
The bleeding lasted for more than a year. At 34, Kellogg had a hysterectomy to remove the device. Still, her medical problems persisted. Since 2013, she has been diagnosed with chronic fatigue, irritable bowel syndrome, fibromyalgia, insomnia and other medical issues-a far cry from when she worked 50-hour weeks as a special-education teacher, all while pregnant with her second child.
Companies face significant legal, financial and PR pitfalls when patient-safety issues arise.
"I literally went from having no medical problems before this, to bleeding for about 424 days, to having a hysterectomy as a young mother with three kids," Kellogg said. "I'm still having issues, even though I got it out."
Kellogg is among a legion of women who are speaking up about severe medical problems they say were triggered by Essure. In recent years, thousands of women alleging harm from Essure have filed lawsuits against Bayer, the device's manufacturer.
Some experts and physicians predict that these efforts will drive Essure off the market, not necessarily because it's deemed unsafe, but because it will no longer be marketable. In the past, other device and drugmakers have done just that after lawsuits, settlements and Food and Drug Administration safety warnings—not formal recalls—made the products a bigger liability than they were worth. Until companies draw that line, patients still face risks.
"I'll be surprised if Essure is being sold 15 months from now," said Erik Gordon, a professor at the Ross School of Business at the University of Michigan. "If Bayer doesn't pull it, I think the FDA will."
Essure was developed in the 1990s by California-based company Conceptus, which Germany-based Bayer acquired in 2013. Between Nov. 4, 2002, when the FDA approved Essure, and Dec. 31, 2016, the FDA received 14,919 reports documenting device migration, organ perforation, severe pain and a slew of other adverse reactions.
In 2016, the FDA mandated a black box warning, the highest-level alert, for Essure. Patients and their advocates continue to call for it to be taken off the U.S. market, as Brazil did in February, when it suspended the importation, distribution and marketing of Essure.
Last year, impairment losses connected to Essure cost Bayer $413 million, according to the company's 2016 annual report. The company expects it will face even more lawsuits.
When asked whether it was considering pulling the device from the market, Bayer said it "stands behind Essure and its positive benefit-risk profile."
"The safety and efficacy of Essure, the only FDA-approved method of permanent birth control with a non-incisional procedure, are supported by more than a decade of science as well as real-world clinical experience," according to Bayer.
But if Bayer does stop marketing the device, it would not be unprecedented. Other companies have withdrawn medical devices from the market voluntarily in the past without the FDA issuing a recall.
In 2014, Johnson & Johnson pulled three types of power morcellators, which are used to extract fibroid tumors, after they were found to have a high risk of spreading cancer. Those devices constituted a small portion of its revenue.
The FDA did not ban or recall the morcellators, but it sent a safety advisory to doctors warning them not to use the devices for uterine fibroids. After that notice went out, J&J pulled them off the market.
"J&J could've kept selling it," Gordon said, referring to the morcellators.
In other cases, J&J stopped selling Pinnacle hip devices in 2013, the same year it paid $2.5 billion to compensate patients over a different product, ASR hip devices. In 2012, its Ethicon division stopped selling mesh urinary implants, over which women had filed thousands of lawsuits against the company alleging harm. The following year, a jury ordered J&J to pay $3.35 million to a woman because the company did not adequately warn her doctor about the implant's potential risks.
Last October, St. Jude Medical recalled nearly 400,000 defibrillators, whose batteries could fail unexpectedly. The FDA recently warned that the company had nevertheless somehow allowed seven patients to be implanted with them, even after the recall. One stock analyst said that could serve as a PR "black eye" for Abbott, which acquired St. Jude in January, the Minneapolis Star Tribune reported.
Costly litigation, settlements and negative publicity are a few precipitating factors that can push a company over the tipping point to pull a device.
"For the company, it's more of a business decision," Gordon said. "At some point, your risk management people look at it and say it's just too financially risky to keep selling these things."
Bayer said it has sold 750,000 Essure devices since 2002, the majority of them in the U.S. It does not release annual sales figures, but the 750,000 figure hasn't changed for at least four years. In a 2013 filing to the Securities and Exchange Commission, Conceptus said it had distributed that same number of Essure devices.
Data from the ECRI Institute, a Philadelphia-based not-for-profit that researches patient safety issues, suggest that some providers are abandoning Essure. In 2014, 365 members of ECRI's PriceGuide service spent $8.34 million to purchase 4,836 Essure devices. In 2015, 299 members spent $5.79 million on 3,244 devices. The following year, the numbers fell further, with 180 members spending $1.98 million on 1,122 devices.
The data have a few important limitations. The majority of PriceGuide members are hospitals and surgical centers. The numbers do not necessarily include purchases by physicians. They also cover only a span of three years, and so it's not clear whether the decline is the continuation of sales trends prior to 2014 or whether it represents a change.
Still, physician feedback corroborates the diminished interest in Essure indicated by those declining sales, regardless of prior trends.
In February, Modern Healthcare polled OB-GYNs about Essure through Sermo, an online social network for doctors. Of the 387 OB-GYNs surveyed, 272 said they had implanted Essure devices in patients. Of those doctors, 175, or 64%, said that their Essure implants per year in the past five years had declined significantly; 42 doctors, or 15%, said the implants had declined a little.
"In the end, the doctors are the biggest gatekeepers," Gordon said. If patients tell physicians that they don't want a device or drug, then physicians, fearing malpractice suits, begin to abandon it, he explained. If sales fall, then the company loses its incentive to keep selling the device, especially if it's increasingly connected with lawsuits and negative attention.
In anonymous comments submitted with the Sermo poll, OB-GYNs in the U.S. offered a mix of opinions. "Essure provides a form of permanent sterilization that is particularly helpful for patients who are not good candidates for abdominal surgery," one said. "However, since reversible options . . . are equally effective, I will be monitoring the risk-benefit profile of Essure closely."
Another said that when the procedure goes well, Essure was "a great method of sterilization," but "when things don't go well (there) can be significant issues trying to remove the implants."
Several said they had stopped offering Essure or significantly scaled back due to side effects.
One OB-GYN weighed in on the "paranoia" around Essure, calling it "one of the worst issues I deal with" and saying it had caused the doctor to perform many more unnecessary laparoscopies.
Amanda Yunker, an assistant professor of obstetrics and gynecology at Vanderbilt University School of Medicine in Nashville, said she has seen "a steady increase" in the number of patients seeking removal in the past few years. She estimated she has removed 80 to 100 Essure devices, none of which she implanted.
Yunker's practice is centered around pelvic pain, and she has noticed that such pain is a common symptom after patients had Essure implanted. "You're never 100% sure, because pain is very subjective and it's multifactorial. There could be a lot of things that contribute to pelvic pain," Yunker said. Nevertheless, "the majority of them definitely had improvement in their pain when it (Essure) was removed," she said.
No medical device or drug is perfectly safe. The fundamental challenge with Essure is knowing which patients are apt to do well with it and which are prone to severe, even debilitating complications. The FDA's position is that those in the former category should have access to the device, even while those who fall in the latter are protected.
"The unfortunate thing is, we don't know where people fall prior to implanting the device," Yunker said.
Many studies focusing on Essure have compared aspects of the procedure, such as methods of pain management or follow-up testing. They have not sought to find relationships between a patient's medical profile prior to the procedure and her outcomes afterward.
According to a systematic review of Essure by researchers in Finland and published in the journal Fertility and Sterility in 2010, long-term data on Essure's safety and efficacy were still unavailable, and there were no randomized controlled studies of the device. The researchers also noted that most studies on Essure have been funded by Bayer.
The FDA has required Bayer to conduct a new study of Essure's benefits and risks that it hopes will shed light on the complications that afflict women who have Essure, compared to those who have tubal ligation.
Essure patients, especially women who are part of the Facebook group Essure Problems, and their advocates argue that the only way to prevent further harm is to remove the device from the market entirely.
But the FDA maintains that the device is safe for a majority of women and that pulling the device would deprive them of an important birth-control option. It also says that the required black box warning does enough to protect patients.
"After significant review and analysis of available information, we believe Essure is safe and effective for many women-but also that some women experience very serious and sometimes debilitating problems," said Deborah Kotz, an FDA spokeswoman.
Meanwhile, the more than 14,000 reports to the agency have "not changed the FDA's determination regarding the benefits and risks of Essure," Kotz said. Essure offers benefits despite these side effects, she added, noting that it is currently the only non-incisional form of permanent birth control.
Kotz said that the updated labeling "helps to ensure that patients are appropriately informed of the risks" from Essure. "Banning Essure would remove the device from the market for all patients-and would limit the options available to physicians and patients." Natalie Hansen, a 47-year-old living in Mooresville, N.C., and a former Essure patient, is skeptical of that approach.
Before she was implanted with Essure in 2011, Hansen recalled, her doctor dismissed her queries about the risk of an allergic reaction to nickel, which Hansen knew even then that she was sensitive to. And since then, she has made more than 70 doctor's visits and endured searing pain, depression, cysts, severe bloating, autoimmune symptoms and a host of other medical problems. Yet she considers herself lucky.
In early April, she had a hysterectomy, and with it, her pain and complications have disappeared-almost miraculously. Her sense of humor, dampened for years by the constant pain, has resurfaced. "Despite having organs taken out, I haven't felt this good in years," she said.
Hansen said that doctors today are fully aware of the risks of Essure, even after the black box warning the FDA issued in 2016. "Who's holding them accountable to make sure they're actually giving this information to patients?" she asked.
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