Canada has just become the latest country to pull Essure off its market, as Brazil did this past February. While Brazil banned the product due to safety concerns, Bayer says it is voluntarily withdrawing Essure from Canada for economic reasons after a drop in sales.
As a non-surgical, hormone-free permanent birth control option, Essure attracted thousands of women hoping to end their fertility in the safest and least invasive way possible.
However, hundreds of women have filed lawsuits against Bayer, Essure’s manufacturer, alleging the company failed to warn of the medical device’s serious side effects. Potentially exposed to misleading information, many more women may believe they are choosing Essure based on convenience without fully understanding its risks.
Essure: The Basics
Essure is a medical device that offers women a non-surgical, hormone-free option for permanent birth control. It consists of two sets of metal coils that work by blocking fallopian tubes and causing scar tissue to form. Approved for commercial distribution by the Food and Drug Administration (FDA) in 2002, Bayer has reportedly sold at least 750,000 devices to date.
However, along the way, the FDA has received almost 15,000 complaints, which include reports of serious, even life-threatening complications following insertion and 1,113 pregnancies. Not only has the device proven ineffective in some cases, but it has caused:
- Instances of perforation, penetration or infection of the:
- Fallopian tubes
- Abdominal cavity
- Peritoneal cavity
- Instances of migration
- Chronic and persistent abdominal and pelvic pain or cramping
- Irregular vaginal bleeding
- Instances of the device internally separating and breaking into pieces
- Adverse reactions requiring device removal
- Adverse reactions leading to death
Bayer claims the device is safe, having conducted limited studies beforehand, but the lawsuits allege the company received an additional 16,000 complaints about Essure and failed to report them to the FDA. In addition, long-term data on the device’s supposed safety and efficacy remains unavailable.
Considering the benefits can’t possibly outweigh side effects as serious as death, when will the United States follow in its neighbor’s footsteps and pull this dangerous medical device from shelves?
Can Essure Cause Any More Harm?
With a 15-year history of safety warnings – including a black box warning – and so many complaints under the company’s belt, it’s a wonder Bayer still supports the sale of Essure. Data suggests that doctors are slowly abandoning Essure to avoid unnecessary revision surgery. Despite deadly risks to patients, and the fact that nixing Essure entirely is the only way to protect them, one can only speculate what will tip the balance.
“I’ll be surprised if Essure is being sold 15 months from now,” said Erik Gordon, a professor at the University of Michigan’s Ross School of Business, who suggested last year that increased marketing had the potential to improve Essure’s reputation. “If Bayer doesn’t pull it, I think the FDA will.”
In the end, it seems commercial viability will always be more important than patient safety to profit-driven companies like Bayer. It’s not uncommon for pharma companies to take devices off the market without an FDA recall. Unfortunately, this isn’t necessarily for safety reasons, but because costly litigation and negative publicity aren’t worth the trouble.
“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.”
Last year alone, Bayer lost $413 Million in impairment losses connected to Essure. More lawsuits are expected in coming months.