Canada: Essure Permanent Birth Control: "Risk Of Serious Complications" – Expect The Unexpected

Last Updated: March 26 2018
Article by Renée Vinett

"You're expecting?!"

Your mind starts to race after you blurt out this question and you anxiously look for a signal to tell you how to react. Is this pregnancy a happy occasion that a woman planned for or tried hard to achieve? Or was this a rather unwelcome 'surprise'?

As birth control technology and family planning education improves, it's more than likely that an impending birth is something the expectant mother is ready to celebrate. Nevertheless, no form of contraception eliminates the risk of pregnancy entirely.

In this blog post, we discuss some of the forms of birth control available, highlight a contraceptive implant called Essure that was marketed as a permanent form of birth control, and explain some of the serious injuries and harm that could result from this potentially defective product.

Choosing A Contraceptive

Whether it's the birth control pill, patch, shot, sponge, or vaginal ring, a cervical cap, a male or female condom, a diaphragm, an intrauterine device (IUD), spermicide, withdrawal, fertility awareness methods, or a surgical procedure (vasectomy for men or tubal ligation for women), any form of birth control outside of abstinence or outer course carries a risk of an unintended pregnancy.

Some of the less effective forms of contraception include the withdrawal method, fertility awareness methods, spermicide, condoms, a diaphragm, a cervical cap or the sponge. These prevent contraception between 71 to 88 percent of the time when used individually. Other contraceptives have proven to have a greater chance of success. For example, the birth control pill, birth control patch or the vaginal ring are 91 percent effective and the birth control shot is 94 percent effective.

Contraceptives with 99 percent effectiveness include hormonal implants, IUDs, vasectomies or tubal ligations. While implants and IUDs require replacement after a period of time, surgical interventions such as vasectomies or tubal ligations require a single treatment.

Another Permanent Form of Birth Control

First introduced to the public in 2002, Essure is marketed as a permanent form of birth control that "works with your body" to prevent pregnancy. Billed as a quick, minimally invasive procedure that can be performed in a doctor's office, it's an alternative to surgical sterilization.

A hysteroscopically-placed tubal implant, Essure is a metal and PET fiber coil device inserted into a woman's fallopian tubes. These coils stimulate a foreign body response that prompts the immune system to create scar tissue. Eventually, this scar tissue becomes a barrier that prevents sperm from reaching a woman's eggs.

Essure's manufacturer reported more than 750,000 of the devices have been sold since 2002, including 8,000 in Canada in 2016 (Source: The Star). Many within the women's health field initially responded positively to this alternative to the more invasive tubal ligation surgery (Source: Washington Post).

Potential Adverse Reactions

Although popular among many doctors and their patients, in the years after Essure's introduction, some women with the implant began to report side effects and unexplained health problems they suspected may be the result of the device.

These adverse effects reports have included:

  • Chronic pelvic pain
  • Allergic reactions to the nickel in the device (including debilitating headaches, migraines, nausea)
  • Excessive scar tissue formation from autoimmune disease
  • Perforation of the fallopian tube, uterus and/or colon
  • Device movement, migration
  • Risk of ectopic pregnancy
  • The need for hysterectomies
  • Other chronic pain

Medical studies have also raised concerns Essure's effectiveness compared to traditional tubal ligation (Source: PubMed) and noted a substantially higher risk for re-operation (Source: BMJ).

Based on adverse-event reports and medical studies, in 2016 Health Canada issued an alert noting a "risk of serious complications" from the device (Government of Canada) and the US Food and Drug Administration issued a rare "black box" warning.

Essure Is Off The Market, But Still Implanted in Many

Although still licensed for sale by Health Canada, in 2017, Essure's manufacturer announced it would voluntarily discontinue the sale and distribution of the device from the Canadian market. In a statement to the press, the company noted: "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 (Source: The Star)."

Discontinuing its sale in Canada (and the United Kingdom and Finland) and a recent ban of the device in Brazil means fewer women will now be subjected to the side effects many others have reported. But for women who still have this defective implant inside of them, or who have required surgery to remove it, the harm has been done.

Consider Your Legal Options: Essure Lawsuit

Women who have experienced these side effects or injuries from Essure should be aware that they may have legal remedies to receive compensation for the pain, suffering and damages that they have experienced.

Qualifying Criteria:

You may qualify to participate in a mass tort action against Essure's manufacturer if:

  • You or a loved one received an Essure implant prior to April 2016, and
  • Have later had to remove it, or
  • Have a removal date scheduled, or
  • Have experienced serious health problem you believe may be related to the device, or
  • Have seen a doctor who has recommended its removal but it cannot be removed due to cost, lack of insurance, health reasons or another serious condition.

As an experienced personal injury lawyer with a background in the health field, we would be pleased to hear your story and explain how the law can be used to help you recover the losses you have experienced due to this defective product.

When you decided to get the Essure implant, you probably weren't "expecting to be expecting" again. You also probably weren't expecting to be faced with serious pain and injuries from this product. However, with the team at Howie, Sacks and Henry as your legal advocates, you can most definitely expect caring, compassionate, and dedicated service to help you on the road to recovery after this traumatic experience.

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