New Updated FDA Essure Adverse Report Numbers – More victims than ever.

August 30, 2017 – San Diego, CA.  We have recently reviewed the FDA Adverse Reporting System latest data on Essure problems that women submit to the FDA.  One of the more staggering numbers we found was the amount of 1,113 pregnancies in patients with Essure.  Bayer says in it’s marketing literature that Essure is 99% effective in preventing pregnancies, however these numbers indicate something else.

When we last looked that the Adverse Reports in 2013 we found:

From Nov. 4, 2002, (Essure’s approval date), through Oct. 25, 2013, the FDA received 943 reports of adverse events related to Essure.FDA Essure Report

The most frequently reported adverse events with the Essure Implant were:

–              Pain: 606

–              Hemorrhage: 140

–              Headache: 130

–              Menstrual irregularities: 95

–              Fatigue: 88

–              Weight fluctuations: 77

The most frequent device problems reported were the migration of the device or device component (116), patient device incompatibility (113) (e.g., possible nickel allergy), device operating differently than expected (73), malposition of the device (46), and device breakage (37).

The Updated Essure Problems Report – The Numbers don’t lie.

As of August 2017 the numbers show a vast increase of all problems related to Essure.

A staggering amount of women have been experiencing problems with the device, and more women are taking time to report problems to the FDA.  Essure broken coils

We encourage all women who have been hurt from Essure to keep posting these Adverse Reports to the FDA.

Here is the link to report any problems you may have had with Essure.

Only then will enough pressure be put on the FDA to take action.  We are hoping that the FDA bans Bayer’s Essure device, before more women are hurt.

From Nov. 4, 2002, (Essure’s approval date), through December 31, 2016, the FDA received 14,919 reports of adverse events related to Essure.

The most frequently reported adverse events with the Essure Implant were:

–              Pain/abdominal pain: 10,746

–              Patient-device incompatibility: 2,402 (nickel allergy)

–              Migration of the device:  1,485

–              Headache: 4,396

–              Heavier menses/menstrual irregularities:  5,377

–              Fatigue: 3,560

–              Weight fluctuations: 3,270

–              Device breakage: 617

Pregnancies in patients with Essure

The FDA has received 1,077 reports that included 1,113 pregnancies in patients with Essure. Some reports contained information on multiple pregnancies. Of the total pregnancies reported: 253 live births were reported; 386 did not indicate whether the pregnancy resulted in a live birth or pregnancy loss; and 474 pregnancy losses were reported.

Among the 474 pregnancy losses reported: 138 were reported as ectopic pregnancies; 75 were reported as elective terminations of pregnancies, and 261 were reported as other pregnancy losses.

European Countries are Halting Sales of Essure

In the last few months we have see many countries outside of the US either banning or halting sales of Essure.  Even Bayer has said it will cease sales – “due to slow sales of the device” in some markets.  Bayer has announced it will discontinue Essure in Canada, France, Spain, Portugal, the Netherlands, and the United Kingdom.  In February 2017 Brazil’s National Health Surveillance Agency, Anvisa (Agencia Nacional da Vigilancia Sanitaria), has suspended and recalled Essure from the Brazilian market.

Bayer halted sales of Essure in the Netherlands in May 2017; the reason they state is a decline in overall sales and will halt all sales in July 2017, then just a few days later they decided to halt sales in Finland.

Following the pull out of those two counties, Bayer reported it would be leaving the UK market beginning September 1, 2017, again stating “commercial reasons.”    Yet Bayer is still selling Essure in America, and we feel the reason is easy to see, huge profits.

Once again Bayer is putting profits over people.  We need to stand together and fight for the rights of women hurt in America from this terrible device.  Learn about the Essure lawsuits forming here.

Essure FDA Adverse Reports