‘Essure’ birth control subject of potential class-action lawsuit in Canada

A Health Canada safety review, ordered in November 2015, follows one conducted by the U.S. Food and Drug Administration. The FDA announced last month it would require a new, mandatory clinical study; a new patient checklist to ensure women are aware of potential risks; and a new so-called “black box” warning label making those risks clear.

The FDA has recommended the Essure packaging indicate some patients have reported “adverse events, including perforation of the uterus and/or Fallopian tubes, intra-abdominal or pelvic device migration, persistent pain, and allergy or hypersensitivity reactions,” and note that some “reported events resulted in device removal that required abdominal surgery.”

A final report from Health Canada is expected in May.

A class-action lawsuit was filed in October 2015 at the Court of Queen’s Bench for Saskatchewan against global pharmaceutical giant Bayer, which manufactures the device. More than 110 Canadian women have contacted Merchant Law Group about the lawsuit.

The statement of claim alleges that Bayer Inc., Bayer Corp. and Bayer Health Care LLC were collectively negligent by: failing to adequately test the device in a way that would “fully disclose the magnitude of the risks associated with use,” and that failing to properly develop and test Essure increased the risk of side effects including “infections, perforated organs, implant migration, pelvic pain and autoimmune disorders.”

The statement of claim also alleges Bayer failed to provide adequate safety data to Health Canada with respect to Essure and argues the company continues to market Essure “in spite of overwhelming evidence that the products are not reasonably fit for use.”

The claim states Bayer failed to provide adequate warnings of potential side effects to patients or physicians, and that Bayer attempted to conceal the adverse effects of Essure from regulatory authorities, the medical community and the public. The claim alleges Bayer failed to adequately train implanting doctors on how to insert Essure and provided implanting doctors with no training on how to remove the coils if they were to migrate.

The statement of claim describes the side effects of two representative plaintiffs as sharp or severe pelvic pain, hair loss, bloating, cramping and heavy menstrual bleeding. Both representative plaintiffs underwent hysterectomies to remove Essure; the claim states their symptoms improved within weeks of having it removed.

The claims have not been proven in court. Bayer Inc., the Canadian division of Bayer HealthCare AG, headquartered in Germany, declined an interview request but provided a statement to the Star on April 14 that read: “Essure is a highly effective permanent contraception option with a positive safety profile for women who want a non-surgical method of permanent contraception.

“Patient safety is Bayer’s top priority. Bayer continuously collects, analyzes and reports all adverse event data it receives and works closely with health authorities worldwide, including the FDA and Health Canada, in monitoring the safety profile of Essure.

“As a matter of policy, Bayer does not comment on active litigation.”

Regina-based lawyer Tony Merchant, whose firm is leading the lawsuit, expects the class action to be certified by a judge later this year.

THE PROMISE OF ESSURE

The method for implanting Essure is less invasive than tubal ligation, the more common surgery where Fallopian tubes are surgically sealed or snipped.

That requires a general anesthetic and an incision through the abdomen and renders women sterile about 99 per cent of the time, according to the Society of Obstetricians and Gynaecologists of Canada (SOGC), a professional society of 3,500 members representing reproductive health practitioners. Essure, on the other hand, is inserted in both Fallopian tubes through the cervix using a disposable catheter, guided by a tiny medical camera called a hysteroscope.

The outpatient procedure requires nothing more than a trip to a doctor’s office, a mild sedative and 10 minutes.

“Essure is over 99 per cent effective at permanently preventing pregnancy,” a Bayer website says.

California-based Conceptus, Inc. ran the clinical trials and manufactured Essure until 2013, when that company was bought by Bayer. The clinical trials submitted to Health Canada as part of the approval process included the possible side effects at rates of less than four per cent: coil expulsion and organ perforation — when an organ wall is penetrated; abdominal pain; cramping and pain during sex; severe pelvic or abdominal pain; severe cramps; bloating and heavy bleeding.

How Conceptus conducted the trials has also been called into question.

Some of the original participants have become vocal critics of Essure, testifying at an FDA panel hearing in September their experiences were not recorded properly or even altered to produce more positive feedback.

The FDA also investigated allegations that Conceptus had altered reporting forms used during the trials in order to edit out negative or painful reactions. The claims were made by a Florida-based law firm in a “citizen petition,” an application allowing Americans to ask the FDA to pull a device from the market.

The FDA found that while 268 modifications had been made to the trial records, that represented less than 1 per cent of the trial data and determined no pattern of changing the reports in a way that favoured the device.

Bayer says about 750,000 women, mostly in the U.S., have Essure. Since the device was approved in the U.S. in 2002, the FDA has received almost 10,000 complaints through its self-reporting database for symptoms including pain and bleeding.

Under U.S. law, manufacturers are shielded from liability for personal injury if their device came to market through the FDA’s stringent pre-market approval process, called the agency’s gold standard because it requires companies to prove a device’s safety and efficacy before it can be sold in the States. In Canada, where Essure has been approved for sale since 2001, companies have no such immunity.

Marlee Scott, a 27-year-old mother of four in Barrie and one of the potential members of the Canadian class-action lawsuit, was 26 years old when she had a hysterectomy to remove the Essure coils put in place by a gynecologist three months earlier. She was relieved.

Scott has four sons: the eldest is 7 and the youngest a one-year-old. Scott delivered all four of her children without an epidural. After she had Essure inserted last June on the advice of a doctor, she experienced pain so severe that her family doctor prescribed painkillers.

“I was in tears because of the pain that I was in,” Scott says.

She told the Star her other symptoms included her hair falling out in chunks, aching joints, so much bloating a neighbour asked if she was pregnant again, and “non-stop” menstrual bleeding. She had the Essure coils removed in August 2015.

“I didn’t want to get a hysterectomy at 26 or at all in my entire life,” Scott says. “I told my doctor, ‘I’ve been on pain meds for the past three months. I want it out.’”

“I look at it like it’s over with and I’m not suffering any more.”

The lawyer Merchant says “the vast majority” of the women in the lawsuit have had hysterectomies to remove the device.

“We think there may be a great many people with this problem,” Merchant says. “We only get a sense of the danger of these products over time as the numbers add up.”

Because it’s permanent, no removal protocol exists, says Dr. John Thiel, who sits on a medical advisory board for Bayer, which is now working on a training video to show surgeons their method for removing the device. Thiel was a consultant for Conceptus, though not involved in the original clinical trials. He says he receives no money and his participation on the board is voluntary.

Health regulators keep track of devices once they are on the market, monitor scientific literature as well as national and international adverse event reporting, Health Canada spokeswoman Maryse Durette told the Star in an email. A February 2015 review of Essure acknowledged adverse events had been reported but “confirmed the overall benefits of the product.”

Health Canada has received 24 reports of symptoms and side effects suspected to be related to Essure. Under medical device regulations, manufacturers are required to report to Health Canada when a device is believed to have failed or contributed to the serious deterioration of a patient’s health. Like the FDA, Health Canada does not verify the adverse event reports.

“The most commonly reported side effects included those already indicated on the label, such as: pain, cramping, bleeding, bloating, nausea, fatigue and vomiting. There were no deaths associated with any of these 24 reports,” Health Canada said in a statement this month.

Between 2002 and 2015, the FDA received 9,900 adverse event reports through its Manufacturer and User Facility Device Experience (MAUDE) database, which is also part of the monitoring process.

Seven out of 10 of those reports involved pain, according to an FDA overview of the reported problems; other symptoms include bleeding, weight gain, nickel sensitivity and device migration. The FDA received 631 reports of pregnancies, around half of which allegedly ended in miscarriage.

The MAUDE website notes the reports, submitted by women, their doctors or by Bayer, are unverified by the FDA and some may be incomplete or duplicated. Regulators are alerted to possible trends and potential device-related safety issues.

A sharp increase in recent years of complaints through the MAUDE database and on social media — a Facebook page dedicated to Essure problems now has nearly 29,000 members — led the FDA to call the panel hearing. A report released last month called for the black box label and new studies.

The American controversy is what in part prompted the review at Health Canada.

“Given new information that was brought to our attention and FDA activity, Health Canada is currently carrying out a followup safety review of the Essure system, before reaching a final conclusion on the potential risk and the need for further risk management measures,” Health Canada spokesman Eric Morrissette said in a statement to the Star late last year.

ESSURE IN CANADA

SOGC president Dr. Margaret Burnett is aware of recent questions regarding the safety of Essure and says her organization is monitoring the process.

“The currently available evidence suggests that complications are rare,” Burnett says.

Only a handful of hospitals in Ontario provide the procedure, including Women’s College Hospital in Toronto, McMaster University in Hamilton and Barrie’s Royal Victoria Hospital and one in Ottawa.

Thiel, the head of obstetrics, gynecology and reproductive sciences at the University of Saskatchewan, was one of the first doctors to introduce Essure to Canadians. He says while the procedure is available across Canada, the uptake has been slow everywhere but Saskatchewan where it is the “procedure of choice.” He estimates he has done around 1,500 procedures there.

While many women have been vocal in their concerns, Thiel says thousands of others are happy with Essure.

“Not all (doctors) have done a good job in talking to, and addressing the concerns of the dissatisfied patients, and that has led to many of the complaints,” Thiel says.

“The answer is not to remove a product that is safer, less risk and has a significantly lower failure rate than other (contraceptive) methods, the answer is to address patient concerns with empathy and understanding,” he says.

Marci Marner, 39, of Regina, approached Merchant in 2014 about a lawsuit and is now a member of the class action. The mother of 14 children through a blended family had Essure inserted in 2004. She says she went to the emergency room the next night for pelvic pain and was sent home with antibiotics.

In the decade that followed, she alleges she developed shingles, autoimmune disorders, heavy and irregular periods, a rare vascular disease and pelvic collapse. Before Essure, she had no allergies, endometriosis or other conditions, Marner says.

Her left Fallopian tube was removed in 2005 after imaging allegedly showed the coil was misplaced. But she claims the coil itself was not removed, remaining lodged in her bowel, which she says was discovered in 2014 when she underwent surgery to remove the right coil.

Marner says she was referred to specialists for her various conditions but none would link her symptoms to Essure. Frustrated, she sought a lawyer.

“No one believed Essure was doing this to any of us,” Marner says. “We were treated like we were hysterical women.”

A judge will now determine whether the lawsuit meets the criteria for a class action in Canada.

In the GTA, only three physicians offer the procedure, which take place at Women’s College Hospital, says Dr. Lisa Allen, the hospital’s site chief of gynecology. She says Women’s College plans to continue offering Essure in accordance with SOGC guidelines and FDA recommendations.

“We still believe in providing this as a safe and effective less-invasive option as long as it’s approved for use in Canada,” particularly for women who aren’t good candidates for tubal ligation surgery, says Allen.

Since 2013, 42 patients have had Essure insertions. None have had their coils removed at Women’s College Hospital, says Allen. She declined to comment on whether any of those patients had experienced negative side effects, citing patient confidentiality.

Physicians are now having a “much more fulsome discussion with patients about the risk-benefit profile,” of Essure, says Dr. Ally Murji, an assistant professor of minimally invasive gynecologic surgery at the University of Toronto who is trained in the procedure. Tubal ligation surgery still carries a greater potential risk, he added.

“We were always getting proper informed consent, but since this whole controversy we are being far more vigilant in documenting and going through all of those risks,” Murji says.