The FDA received 5,016 medical device reports involving Essure in 2016, plus another 6,176 reports in 2015, and 30 reports of deaths. The deaths include four adult women, 18 pregnancy losses, two infants who died after they were born, and a possibly stillborn baby.

Many reports listed multiple side effects. The most common problems with Essure included:

  • Pain/abdominal pain (10,746)
  • Heavier menstrual bleeding or irregularities (5,377)
  • Headache (4,396)
  • Fatigue (3,560)
  • Weight changes (3,270)
  • Patient-device incompatibility, such as nickel allergy (2,402)
  • Pregnancy (1,113)
  • Migration of Essure (1,485)
  • Broken Essure (617)
  • Pregnancy losses, ectopic pregnancy, abortion, miscarriage (474)
  • Essure difficult to remove (304)
  • Malposition of Essure (261)

The FDA update also provides new details on an ongoing Essure safety study that will compare 1,400 women who are sterilized with Essure against 1,400 women who have a traditional “tube tying” sterilization.

So far, the study has not shown any new safety problems or an increased risk of problems since Essure was approved. The researchers are investigating side effects like chronic pain, abnormal uterine bleeding, allergic reactions, hypersensitivity to nickel in Essure, autoimmune diseases, follow-up surgery, pregnancy, and effectiveness.

However, other recent studies have already shown that women who choose Essure are 10-times more likely to need another surgery compared to women who have a laparoscopic tubal ligation.

Essure is a metal coil that is permanently implanted in a woman’s fallopian tubes, where it causes irritation and scar-tissue growth. Essure is supposed to block the fallopian tubes to prevent pregnancy. Instead, many women got pregnant or developed severe side effects.

In November 2016, the FDA added a “Black Box” warning label to Essure, which is the strongest label the FDA can require on a device. The FDA also created a checklist to better inform patients about the potential side effects.

The problem is that Essure is marketed as a 30-minute non-surgical outpatient procedure for busy women, with less pain and a faster recovery time than tubal ligation. Lawsuits have been filed by women who accuse manufacturers of downplaying risks and violating approval requirements to get Essure on the market without adequate safety studies.

Source: Reviewing Ongoing Clinical Study to Gather More Information on Essure Benefits and Risks

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Elizabeth Bradley

Posted by Elizabeth Bradley

Lifelong consumer advocate. Pop culture nerd. Grammar evangelist. Wannabe organizer. Travel addict. Zombie fan.

5 Comments

  1. Essure is a horrible product. Do not opt for it.

    Reply

  2. The FDA is reporting 10000 injuries? Really? In the Facebook group alone there are 32,000 members! And those are only the ones lucky enough to have found the group and their resources. And the statistics on types of injuries… really? Those are maybe an eighth of the side effects. I am one of the lucky ones. Going for my essure/hysterectomy May 1. I cant wait to get my life back!

    Reply

  3. Bayer admitted on camera autoimmune disease were contributed to assure implants I don’t see them on this list and autoimmune disorders have a hell of a lot of side effects and I don’t see any those on here either sorry for the curse word we are missing a lot of side effects and you have been undermining the side effects of this device and we are tired of it get your side effects correct because we’re tired of being looked at like we’re crazy and doctors not able to treat women properly and in a timely fashion because I don’t have all the side effects to look for you have the side effects we’ve given them to you now use them and give them to doctors at least

    Reply

  4. I have essure 0n 2008 by the 1st time…And im having my surgury soon just because all the bad symptoms and bad pelvic pain and headache…Good luck to every girl

    Reply

  5. I’m hoping for mine too be removed in which they had been placed in 2011 and hopefully soon and hopefully be recovered and back too my self and life style I’m so tired of this and I cannot believe the stories I look up! How much longer do we have too wait for something good too happen too all these women whom are suffering?Hopefully not till there’s death and unborn children’s life’s and infants who died from it too happen no more!

    Reply

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