Did you see a commercial alerting women who received Essure implants to the possibility of legal action? Many of these commercials mention that Essure has been linked to severe side effects, from pelvic pain to autoimmune disorders, and urge patients to contact an experienced Essure attorney immediately.
What Essure Commercials Don’t Tell You
At BirthControlProblems.com, our lawyers don’t produce TV commercials. But we are committed to informing patients of their legal rights, and helping them pursue justice and compensation whenever possible.
Here’s what the TV commercials don’t tell you about Essure lawsuits:
Hundreds Of Women Have Filed Essure Lawsuits
Hundreds of women have filed lawsuits against Bayer Pharmaceutical, the major corporation that now manufactures and markets Essure.
The implants were initially designed by a company called Conceptus, but Bayer purchased the smaller medical device manufacturer in 2013 – with the sole intent of adding Essure implants to its product line, Bloomberg reports.
In their complaints, more than 500 patients accuse the company of hiding troubling study results from the US Food & Drug Administration, which approved Essure for sale in 2002. That approval, the women say, was based on a mountain of lies. By their account, Conceptus manipulated critical clinical trials, even falsifying patient reports of physical pain, to make Essure look safer and more effective than it actually is.
Is Essure Even Effective At Preventing Pregnancy?
In reality, patients claim, Essure causes devastating side effects. And the device is far less effective than previously thought, according to Yale researcher Aileen Gariepy, MD, who wrote in 2015:
“the evidence suggests that [Essure] is neither as effective nor as safe as the pre-marketing approval evaluation indicated”
Gariepy has studied Essure extensively and, in her most comprehensive analysis, estimates a 5.7% annual risk of pregnancy among women who receive the implants. Over the course of 10 years, up to 9.6% of women with Essure could become pregnant – despite relying on the device solely to prevent that possibility. On the other hand, the industry standard for permanent female sterilization, tubal ligation, carries a far lower risk. Only 24 to 30 out of every 1,000 women who undergo tubal ligation will become pregnant within a 10 year time period.
Potential Essure Complications & Side Effects
Today, thousands of women say that they suffered severe side effects after undergoing the Essure procedure. In many cases, Essure removal has become necessary, with numerous patients being forced to undergo hysterectomy procedures in order to alleviate their often devastating symptoms.
On the website Essure Problems, a support and advocacy group for women who developed serious symptoms after receiving the implants, patients have listed 135 potential side effects and complications. According to an FDA analysis of patient and healthcare provider reports, the most common side effects linked to Essure include:
- pelvic pain
- abdominal pain
- menstrual irregularities, like heavier menses than usual
- weight fluctuations
But the potential effects of Essure implants go far beyond the symptoms we listed above. Many women say they were never adequately warned that Essure is made of nickel, an element that caused them severe allergic reactions. The implants have even been linked to autoimmune disorders, a potential consequence that some researchers attribute to heightened immune system responses prompted by a “foreign invader.”
Beyond side effects, many women have discovered that their implants broke apart inside their bodies, releasing dangerous metal shards and polyethylene fibers (more commonly known as polyester) inside the uterus.
Essure Lawsuits Move Forward, Despite Odds
Pursuing justice in court isn’t easy, but for women who believe they were harmed by Essure, the litigation process has proved even more challenging.
As a “high-risk” medical device, Essure was approved through a special, and supposedly more rigorous, FDA approval process. But moving through this expensive approval pathway can afford manufacturers an extra degree of immunity from product liability lawsuits, which are normally based in theories of state law. For its part, Bayer has long argued that the women have no right to sue, since a federal agency approved Essure based on the device’s presumed safety and efficacy.
From the beginning, the fate of Essure lawsuits has been in doubt.
But women have already won major victories in court. In a California State court, a judge recently allowed the lawsuits filed by 14 women to proceed – despite Bayer’s arguments for legal immunity. A similar judgment was handed down in a Pennsylvania federal court, where five lawsuits were approved to move forward in April 2016.
Contact An Essure Attorney Today
While these recent court decisions are limited in their scope, legal experts believe that significant progress has been made. Thousands of women may be eligible to file Essure lawsuits of their own, pursuing financial compensation to cover past and future medical expenses, lost wages and pain and suffering.
If you or someone you know suffered severe side effects after receiving Essure implants, contact our experienced Essure attorneys now for a free consultation. You can learn more about your legal options at no charge and no obligation. Just call or fill out a contact form today.