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Essure, a contraceptive available in Canada, under scrutiny in U.S.

The FDA is looking at claims of scary side effects associated with the device, which is approved by Health Canada.

Uterus transplants are now being performed in the United States

April 18, 2016: Essure is now subject to a possible class action lawsuit in Canada, the Toronto Star reported in an in-depth investigation today. The potential lawsuit involves upwards of 100 women, many of whom claim they had to have hysterectomies to remove the coils from their Fallopian tubes.

Last September, hundreds of women from across the United States stood before a Food and Drug Administration special committee panel to share their experience using Essure, a contraceptive device the agency long considered safe: Intense cramping. Persistent bleeding. Chronic pain. Rashes. Loss of bowel control. Unwanted pregnancy.

It was a day that came after five years of mounting complaints against the device — a Bayer product also available in Canada that promises permanent sterilization, a 99 percent guarantee a woman will never get pregnant again. Surgeons implant a tiny metal coil in each Fallopian tube and tissue fills in the space between the coils in the three months following. Once healed, the Fallopian tubes are fused shut forever. The procedure, known medically as hysteroscopic sterilization, is widely seen as a cheaper and less invasive alternative to tubal ligation (having your "tubes tied").

But there is evidence the FDA may have relied on flawed studies when it first approved Essure in November 2002, finds a new Refinery 29 investigation, which also chronicled this grassroots effort waged by women — self-dubbed "E-Sisters"' — who feel they hadn't been adequately warned about the risks associated with this type of sterilization. One woman became pregnant after the coils migrated from her fallopian tubes to another part of her body and now suffers daily pain.



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The report comes on the heels of increased scrutiny over the product, including a study published last October that estimated more than 10,000 American Essure patients have required re-operations over the past few years.

Amidst all of this, Bayer has stuck by its product and says patient safety is its top priority.

"The safety and efficacy of Essure is supported by more than a decade of science and real world clinical experience," Bayer spokesperson Tara DiFlumeri told Refinery 29.

In March, the FDA mandated Bayer perform a new study on the effects of Essure and place a "boxed warning" on the device so the side effect risks are crystal clear. The federal agency is still investigating whether the clinical trials were conducted properly.

Health Canada approved Essure in 2001 and has logged only 23 complaints against the product in the 15 years since. Seventeen of these complaints were made by doctors and hospitals and six were made by individual women.

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The most commonly reported side effects in Canada have been pain, cramping, bleeding, bloating, nausea, fatigue and vomiting — all side effects listed on the product. There have been no reported deaths.

Health Canada does not keep track how many Canadian women have had Essure implanted, but Bayer told Refinery 29 that 900,000 devices have been sold.



The FDA's website reports 631 pregnancies from people who'd had Essure implanted. Of those, 150 of those pregnancies resulted in live birth, 204 had no recorded outcome, and 294 ended in pregnancy loss, including 94 ectopic pregnancies, 43 abortions and 155 miscarriages.

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While these E-Sisters amassed a community of Essure complainants over Facebook, medical experts have raised questions over the efficacy of the device's clinical trials. North Carolina surgeon Charles Monteith told Refinery 29 the pre-clinical trials did not look for long-term complications. He believes Bayer was "running an uncontrolled trial on American women as a result of the decisions that were made when the device was approved."

Yale University postdoctoral fellow and medical doctor Sanket Dhuvra also studied the pre-clinical and post-clinical trials for Essure and found they did not compare results against other methods of sterilization (including tubal ligation). Most of the 745 women included in the original studies weren't followed for the full five years — only 197 were still being followed two years after they got the Essure implantation.

In the meantime, Health Canada still considers Essure a safe permanent contraceptive but conducts reviews of its approved products.

"When we know something might not be good for Canadians, we'll of course go and check and say 'OK, do we need to take this off the market?'" said Health Canada spokesperson Maryse Durette. "The review is indeed ongoing."

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