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Essure Birth Control Concerns Continue to Spread, Canadian Government Moves to Strengthen Medical Device Oversight

Dec 11, 2018

Concerns about the implantable birth control device Essure, manufactured by Bayer, are continuing to spread on a global level. Though Bayer will be suspending sales of Essure worldwide by the end of this month, questions still remain for thousands of women who have experienced pain and adverse reactions after having the device implanted.

Those lingering concerns and the stories of numerous women worldwide have prompted many countries to take more decisive action. This includes an order issued late last month by the Canadian Health Minister to strengthen regulations for medical devices, including improved standards for complication reporting, and stronger pre-market studies.

Essure: A Global Timeline of Pain & Adverse Health Complications

On our blog, we have featured many posts about the ongoing backlash over Essure, a small device comprised of a metal coil that can be implanted into the fallopian tubes for female sterilization. Although it gained popularity for being a minimally invasive and convenient form of birth control for women, and a purportedly safer option than tubal ligation, it has become the target of numerous concerns from patients, advocates, and regulatory agencies, as well as numerous lawsuits.

Today, more than 1 million women across the world have received Essure implants. However, reports of serious adverse reactions, years of physical and emotional pain, and thousands of painful removal surgeries linked to Essure soon prompted action from health regulators. That’s true in the U.S., where the federal Food and Drug Administration (FDA) issued a “black box” warning label and requirements for physicians to thoroughly discuss risks and issues with patients prior to implantation.

In Canada, a journalistic investigation by the Canadian Broadcasting Corporation (CBC) found a severe lack of adverse event reporting, despite hundreds of Canadian women voicing their stories and complaints, and growing evidence about Essure being approved with potentially incomplete evidence about its safety, including one 2015 study published in the New England Journal of Medicine. The investigation soon led to Essure being discontinued in Canada in 2017, and the Canadian Health Department’s recent decision to improve how it oversees the approval and reporting process for medical devices. Similar steps have been taken in other nations where Essure has been sold.

Regulatory Changes Welcomed, But Women Still Reeling

Though pledges to revamp regulations regarding medical devices, pre-market testing and approval, and reporting are certainly steps in the right direction, they do not detract from the fact that thousands of women have already suffered, and are still suffering, from complications related to Essure, including issues such as:

  • Excessive and constant bleeding
  • Chronic pain, backaches, headaches, and migraines
  • Blood clots, hemorrhaging, infection,  and perforation of organs
  • Device breakage and migration
  • Pregnancy complications, including ectopic pregnancy
  • Costly and painful corrective surgeries
  • Hysterectomies and other organ-removal procedures
  • Renal failure, bowel dysfunction, and other conditions / disabilities

In light of the serious physical, emotional, and financial suffering endured by many women, the civil justice system has become the means through which they are sharing their stories, and which they hope will provide an opportunity for more information about what Bayer knew about Essure to come to light. Women who seek justice in Essure lawsuits may also recover financial compensation for their economic and non-economic damages.

Questions About Essure Lawsuits? We Can Help.

Bailey Cowan Heckaman PLLC, LLP is a nationally recognized trial firm that has earned a reputation for fighting on behalf of the injured and the wronged, including victims who suffer serious injuries and damages as a result of dangerous pharmaceutical drugs and medical devices like Essure.

If you or a loved one has experienced harm and losses after having Essure implanted, our award-winning attorneys are available to discuss your case and whether you may be able to join thousands of other women with pending lawsuits against Bayer. Call (888) 367-7160 or contact us for a free and confidential review of your case.

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