After receiving the Essure sterilization procedure, thousands of women have described severe side effects and complications that they believe were caused by the implants. Obviously, not all birth control methods are created equal.
More than 26,000 women have already added their personal stories to the Facebook group for Essure Problems. Over 2,100 women signed a Citizen’s Petition to get Essure recalled. After it was submitted, legislators like Pennsylvania’s Mike Fitzpatrick got involved. Fitzpatrick has even submitted a bill to Congress that would remove Essure from the market.
6 Steps To Officially Report Your Essure Problems
More importantly, patients are going directly to the US Food & Drug Administration, the federal agency tasked with keeping us safe from dangerous medical devices. Over the last 2 years, the FDA received more side effect reports from individual women than it did from health care providers.
But the agency still hasn’t made a decision on what to do with Essure. Right now, it’s up to us, as citizens, to make our voices heard for public safety.
Here’s how to report your side effects directly to MedWatch, the FDA’s medical device monitoring system. In order to provide the FDA with all the information they need, you might have to gather together relevant health records. But don’t worry; if you can’t find them, or can’t get them for some other reason, you can still make a report.
1. Head To The FDA Website
You can go directly to the official MedWatch website here: http://www.fda.gov/Safety/MedWatch/
You’ll see a page like the one below. Click on “Report A Problem.”
2. Begin Your Report As A Patient
On the next page, click the button under “Begin Report As a:” that says “Consumer / Patient.”
3. Describe Your Problem
On the report’s first page, “About Problem,” you’ll be asked to define the problem, side effect or complication by selecting between different options.
First, select the box for problems with a “medical device”; it’s below the box for problems with a “product.” In the next section, choose the box that best describes the kind of problem you experienced. For most women, “were hurt or had a bad side effect (including new or worsening symptoms)” will be the most appropriate option.
Then you’ll be asked about how you were affected by the side effect or complication. There are options for:
- Hospitalization – admitted or stayed longer
- Required help to prevent permanent harm (for medical devices only)
- Disability or health problem
- Birth defect
- Death (include date)
- Other serious / important medical incidents
You can choose more than one of these options, so select any that you feel apply to your situation. Women who were forced to undergo hysterectomy because of an Essure problem should choose “Required help to prevent permanent harm” at the least.
In the next box, you’ll need to describe the problem in your own words. You have 4,000 characters to explain the complication and outline why you think it happened. Next, you’ll have 2,000 characters to provide the agency with information on relevant tests and lab results. This section isn’t required, but can be extremely helpful for FDA reviewers. If you have records from the Essure Confirmation Test, given to every patient 3 months after implantation, this would be a good place to mention them, along with the date on which the Test took place.
Finally, you can assign a date for the event, but that isn’t required.
4. Describe The Device
On the next page, you’ll be asked to describe the device that you think caused your side effects. Obviously, we’re talking about Essure here. You won’t be able to complete some of these fields (like the device’s expiration date), unless you can contact the doctor who conducted your procedure and get the information from them. It’s okay if you can’t complete this page fully. Just make sure to include Essure’s manufacturer in the “Company” field:
Mention both Conceptus, the company that designed and first manufactured Essure, and Bayer, the company currently behind the contraceptive.
If you can find information on the specific serial number and “unique device identifier” (a serial number exclusively for medical devices) for the implants you received, you can add them below the Device Information box.
Below the field for “Expiration Date,” you’ll see a box for the date you received the implants and, if applicable, the date the implants were removed. Feel free to call your doctor, or search through your own health records, to find this information. It’s not required, so if you can’t remember exactly, don’t worry.
The last two questions on this page ask you if someone was operating the device when you experienced the side effect, and if so, who. This question is more for devices used during surgical procedures, but if you experienced a complication during the implantation procedure, it may apply to your situation.
5. Describe Yourself
The next page asks you to fill out some personal information about yourself. None of this information is required, so if you don’t feel comfortable disclosing your identity, don’t.
6. Sign The Form & Submit
On the form’s fifth page, you have to put in at least your first and last name. Since you’re submitting a voluntary report, you are considered the “reporter” in this situation.
You can also choose to send your name and contact info to Essure’s manufacturer, but be aware that they may actually contact you.
Now click “Next,” review your answers and click the “Submit” button at the bottom of the page.
Other Ways To Report Essure Side Effects
You can also call the FDA directly to report your side effects. Just call 1(888) 463-6332, and listen to the automated prompts. At the main menu, you can choose either 2, and be forwarded directly to the MedWatch reporting system, or 3 to speak with a representative of the FDA.
MedWatcher is another site you can use to report complications. It was designed by Boston Children’s Hospital and Harvard Medical School, in collaboration with the FDA. It’s pretty easy to use; just select “Report A Side Effect Now” on the Home page, find Essure in the “Devices” menu and follow the prompts. Once you’re done, the report will be sent to the FDA. It’ll also be published on MedWatcher, so other people can learn about problems caused by medical devices. MedWatcher removes all of your identifying information before publishing to its database of public reports. There’s also a MedWatcher app you can download on your phone.