How to Post an Adverse Event with the FDA

Pacemaker, Courtesy WikiCommons, Steven Fruitsmaak

MND, August 30, 2015 ~When you have a new car that develops a “safety” issue i.e. braking, steering, airbags, wiring, engine cooling, unintended acceleration etc, the auto dealer reports the problems to the manufacturer, who by law, must report the issue to the National Highway Traffic Safety Administration within five days.

But when a patient has a problem with a medical device, don’t depend on mandatory reporting. Or any reporting at all. Your doctor may report the problem, but then again he or she may not. A problem may reflect badly on his surgical skills.

But you should still report your adverse event. How many patients understand how to report an “adverse event” to the Food and Drug Administration? (Disclosure- this story first was published on this day August 30, 2011, on Mesh News Desk).

An adverse event can be any complication from a drug or medical device and it is the only way the federal agency can track problems.

The FDA reported in July that from Jan. 01, 2008 through Dec. 31, 2010, it received 2,874 additional reports of complications associated with surgical mesh devices used to repair POP and SUI, with 1,503 reports associated with POP repairs and 1,371 associated with SUI repairs.

Because of the lapse in reporting, problems that are reported are suspected of reflecting just a fraction of what occurs in the real world - as little as one percent.

How to Report an Adverse Event

You can report directly to MedWatch, the FDA Safety Information and Adverse Event Reporting program online:

• By phone- 1-800-FDA-1088
• By FAX – obtain a fillable form online and print it out and fax it to 1-800-FDA-0178
• By mail – or mail it to MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787

MedWatch Online Voluntary Reporting Form (3500) is here.

Look up Adverse Events:

Manufacturer and User Facility Device Experience (MAUDE) data

As it stands now, the injured have to find the FDA’s MAUDE database (Manufacturer and User Facility Device Experience Database) and understand the criteria to enter to pull up injuries resulting from your mesh. It can be intimidating, and if they are involved in litigation are generally advised not to enter information.

For example, in the case of mesh patient, Suzanne McClain (Suffering in Silence- Part 1) finding data on Ethicon’s Gynecare Tension Free family of mesh products involves knowing the criteria:

1.) Product Class: Mesh, Surgical, Polymeric (You will have to scroll through the M’s to find this phrase.)

2.) Brand Name: Tension Free

3.) Date Report Received by the FDA: (Date Range) 05/12/1999 to Current Date.

4.) Records Per Report Page: Change to 500 and click Search.

A National Registry

The purpose ultimately of the patient advocacy group, Truth in Medicine, is to stop the marketing and implantation of synthetic surgical mesh. Information collected on an international user-friendly registry would be passed onto Congress to accomplish that goal.

Surgeons who remove surgical mesh (Suffering in Silence-- Part 3) also support a registry to get some idea of the big picture of complications of synthetic surgical mesh.

Getting More Information

At the FDA’s Office of Surveillance and Biometrics by e-mail at phann@fda.hhs.gov or by phone at 301-796-6640.

Enroll to receive Public Health Notifications here.