Canada: Birth Control Device Essure Being Pulled From American Market

Last Updated: September 10 2018
Article by Valerie Lord

If you're a Netflix fan who eagerly investigates new releases on the streaming service, you may have already come across a 2018 film called "The Bleeding Edge." 1 The title might lead you to believe it's a horror movie, but it's actually a superbly produced new documentary that is probably scarier than any horror movie we've seen.

The film explores the $300-billion per year medical device industry and the American Food and Drug Administration's (FDA) approval process.2 Focussing on patient stories of adverse events relating to medical products such as cobalt-joint replacements and hernia and vaginal mesh, "The Bleeding Edge" pays particular attention to an implanted permanent birth control device known as Essure.

Regular readers of the HSH blog may recall my colleague Renée Vinett's article on this form of birth control and a related mass tort action. In this article, I'll discuss the contribution "The Bleeding Edge," has made to the debate over faulty medical devices and report on some recent developments announced by the FDA and Essure's manufacturer Bayer.

The Essure Story

The main narrative arc of "The Bleeding Edge" tells the stories of women who have suffered serious health issues after receiving Essure birth control implants. Essure, a hysteroscopically-placed tubal implant is an alternative to surgical sterilization through tubal ligation. A metal and PET fiber coil device is inserted into the fallopian tubes to create scar tissue. This scarring becomes a barrier preventing sperm from reaching a woman's eggs.

The filmmakers profile multiple women who have had the procedure, including Gaby Avina, Ana Fuentes, and Angie Firmalino. Avina, a former spokesperson for the product, worked as a nurse who participated in advocating the procedure and also chose to use it for her own sterilization. The film chronicles her own health problems attributed to the device and the guilt she feels for her role in promoting it to many other women and doctors. With Fuentes, an accountant executive with four children, we watch as her decision to have a simple, surgery-free procedure brought about severe health issues. She reveals how these complications contributed to a breakdown in her marriage, the loss of her job, and even led her to surrender her children into foster care as she battled homelessness while waiting to receive disability benefits.

Firmalino had Essure implanted and subsequently removed after one of the coils migrated into her uterus. When bleeding and other problems continued following the removal surgery, she returned for observation and describes a horrific scene in a hospital room when blood clots poured out of her. The experience prompted her to search to see if other women had suffered similar problems or had mystery illnesses that were likely related to the product. Through social media interactions, she identified and organized thousands of women into action, including participation in protests and meetings with US congresswomen sympathetic to their cause.

The FDA And Bayer's Response

Firmalino and other members of her organization met with FDA Commissioner Dr. Scott Gottleib in February 2018 to discuss their health problems, provide years of data on Essure and request that he remove it from the marketplace.3 The following month the agency reported it had received 12,000 reports of adverse events linked to Essure in the previous year; 90 per cent of these reports related to removal attempts. The FDA noted that most reports were submitted by legal representatives on behalf of their clients.4

On April 9, 2018 the FDA announced new restrictions on the sale and use of the device. These unprecedented restrictions included requiring women to read and sign a pamphlet describing potential risks and having the doctor performing the procedure sign a similar checklist of risks. However, the device remained on the market.5

Months later, and very shortly after "The Bleeding Edge" premiered, Bayer announced its intention to "end sales and distribution of the device in the U.S. by the end of the calendar year for commercial reasons". The FDA reported that sales of the device had declined by 70 percent since it had ordered the company to conduct a post-market study and added new labelling requirements in 2016.6

Here in Canada, Bayer had already announced in 2017 that it was no longer going to be selling its product.7 In a written statement provided to Toronto Star, Bayer Canada stated "In light of the change in patient demand, Bayer has decided to voluntarily discontinue the sale and distribution of Essure in Canada over the next few months. This decision was taken for commercial reasons, and the favourable benefit-risk profile of Essure remains unchanged. This is not a recall of the product from the market".8

Not For The Faint Of Heart

Although the story of Essure and the frightening health problems some women have faced is the main focus of the film, there are many other segments of this documentary that will render viewers uneasy. Filmmakers working within the horror genre seem to go out of their way to try to create bigger scares, display more gruesome images, or generate more blood-curdling screams from audiences every passing year. Yet, when you watch "The Bleeding Edge," there is a near constant sense of dread that chills you to the bone. The reason? Even though they sound like figments of a warped mind and overactive imagination, the stories you hear happened to real people.

For example, in the film we meet a medical doctor who began experiencing strange health issues (including tremors, ringing in his ears and progressively worsening problems) following a cobalt-hip replacement. His wife describes receiving a phone call while her husband was attending a conference informing her that he had suffered a psychological breakdown. In a scene not out of place in "The Shinning," she learned he had trashed a hotel room by writing all over the walls and ceiling with markers, sharpies and soap. The doctor explains how he believes cobalt poisoning from the deteriorating joint led to these symptoms – something he has since observed and researched in other patients. Photos of the metallic sludge seeping out of the removed joint is the stuff of nightmares.

Another vignette pulls together interviews from women who have had hysterectomy surgeries through Da Vinci robotic procedures. The women describe how post-surgery vaginal cuff dehiscence caused their intestines, colon, or other interior tissues to be suddenly expelled and left hanging out from their bodies. We learn that vaginal cuff dehiscence occurs three to nine times more frequently with robotic surgery.9

One woman interviewed had vaginal mesh implanted and subsequently partially removed after experiencing health problems. She tells the story of how, after recovering from the remedial surgery, she looked forward to being intimate with her husband again. Unfortunately, some of the remaining mesh cut the head of his penis during intercourse. "As a woman, you're thinking, 'Am I ever going to have relations with my husband again? Was he ever going to want to stay with me?'" she explains.10

The FDA Approvals Process

These stories might appear to be gratuitous or for shock value, but they serve as examples of adverse events that, in theory, should be reported to the FDA and other health regulators to ensure public safety. Unfortunately, as editor of JAMA Internal Medicine Dr. Rita Redberg notes, it's estimated that only three to four per cent of all adverse events get reported to the FDA.11

Dr. Redberg explains the reporting system for adverse events is voluntary for physicians and only mandatory for manufacturers. "The industry is not interested in having problems with devices become apparent," she states. One study found that the worse the adverse event, the less likely it was to be reported.12

As a product liability lawyer, this is sadly not news to us. Dr. David Kessler, an FDA Commissioner from 1990-1997, suggests that while the "FDA does a credible job with the vast majority of products, the problem we have is that when it comes to medical devices, we built a system that doesn't work."13

Initially all medical devices were required to get pre-market approval. When the industry argued that so many of the new products coming onto the market were merely iterations of existing products, the American Congress created something to speed up the process. Called the 510K exemption, it granted pre-market approval of products deemed to be substantially similar to already approved products.14

"That provision, which was meant as an exception, in essence a little loophole – that exception became the rule," Dr. Kessler noted.15 Today 98 percent of products are regulated under 510K while only two percent go through pre-market approval.16 And even this approvals process is not as stringent for medical devices as it is for new drugs. Moreover, a product approved under a 510K exemption does not face immediate recall or warning if the "substantially similar" product used to exempt it is later connected to adverse events and recalled.17

A Happy Ending, Or Just The Beginning?

While news of Essure's exit from the market makes for a satisfying cinematic conclusion to the film, for people watching this documentary at home who are experiencing similar symptoms or problems with their implanted medical devices, the story isn't over.

Haven't watched the documentary, The Bleeding Edge? Watch the trailer here.

Footnotes

1-3 "The Bleeding Edge" by Kirby Dick and Amy Ziering. http://bleedingedgedoc.com/

4 "U.S. FDA puts restrictions on Essure birth control implant but no recall." CTV News.

5  "The Bleeding Edge" by Kirby Dick and Amy Ziering. http://bleedingedgedoc.com/

6 "Statement from FDA Commissioner Scott Gottlieb, M.D., on manufacturer announcement to halt Essure sales in the U.S.; agency's continued commitment to postmarket review of Essure and keeping women informed."  FDA Website.

7/8 "Controversial Essure birth control device will no longer be sold in Canada." The Star.

9-17 "The Bleeding Edge" by Kirby Dick and Amy Ziering. http://bleedingedgedoc.com/

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