How You Can Report Adverse Events to the FDA

June 25, 2015 — San Diego, CA

With the fight against the Essure implant gaining popularity in social media lately, Esssure Problems Facebook group and on Twitter, it is crucial to know how to properly report your adverse events involving Essure to the FDA.

FDA Logo. (PRNewsFoto/U.S. Food and Drug Administration (FDA))

FDA Logo. (PRNewsFoto/U.S. Food and Drug Administration (FDA))

Yesterday, the FDA made an announcement that they would be looking further into the concerns expressed about Essure by thousands of women. There will be a meeting held in September to discuss the safety and effectiveness of Essure. Don’t wait until this important meeting is over to make your voice heard about the dangers of Essure.

What is FAERS?

FAERS (FDA Adverse Event Reporting System) is a database that contains information on adverse event and medication error reports submitted to the FDA. FAERS is designed to support the FDA’s post-marketing safety surveillance program for drug and therapeutic biologic products.

How does the FDA use FAERS?

The system is a helpful tool for the FDA in activities such as looking for new safety concerns that could be related to a marketed product, evaluating a manufacturer’s compliance to reporting regulations and responding to outside requests for information. The adverse reports are evaluated by clinical reviewers in the Center for Drug Evaluation and Research to monitor the safety of products after they are approved by the FDA. If a potential safety concern is seen in FAERS, further evaluation is performed. This may mean conducting studies using other large databases or updating the labeling information of a drug. In rare cases, a product will be removed from the market.

Who reports to FAERS?

Healthcare professionals and consumers voluntarily report adverse events to the FDA. Healthcare professionals include physicians, pharmacists, nurses, and others, as well as consumers including patients, family members, and lawyers. When a manufacturer receives an adverse event report, they are required to send the report to the FDA.

How can you report an adverse event to the FDA?

Follow these steps to report an adverse event to the FDA:

  1. Go to https://www.accessdata.fda.gov/scripts/medwatch/. This will take you to the MedWatch Online Voluntary Reporting Form Homepage.
  2. On the right hand side of the page, find “Begin Report As A:” and click on Consumer/Patient.
  3. Follow the directions to explain your negative experiences with Essure to the FDA. Make sure to click “Submit.”

You can also download and print out a paper report here. If you decide to print out your report, you can either fax the completed report to 1-800-332-0178 or mail it to:

MedWatch

Food and Drug Administration

5600 Fishers Lane

Rockville, MD 20857

If you have had a traumatic experience with the Essure implant, please report your story to the FDA by following these steps. No woman should have to go through what thousands of women are currently experiencing from having Essure implanted in their bodies. Essure women have gotten this far, let’s continue to show the FDA how dangerous this device is for women’s bodies and give them plenty of adverse events to discuss in the meeting on September 24th.

If you or someone you love is suffering side effects from the Essure Implant, contact our Essure lawyers today, click the banner below to access the Essure Claim Evaluation form.

Zofran form

Source: RAPS, FDA