Have You Filed Your FDA Adverse Event Report Concerning Surgical Mesh?
She found the MAUDE database inside the FDA. Here is the URL for her anonymous report she made after receiving the Gynecare (J&J) Prolift mesh kit. See it here.
You can also go to MedWatch and report your adverse event.
What is an adverse event? It is a sanitized way of saying complications, in this case, from pelvic, hernia or transvaginal mesh. That can include mesh erosion, chronic pain and infection, mesh migration, nerve entrapment, chronic urinary tract infections, sepsis, foreign body response, autoimmune issues, among other responses.
The U.S. Food and Drug Administration (FDA) has delayed for years upgrading its reclassification of pelvic mesh for POP (pelvic organ prolapse) to Class III or likely to cause serious injury, so one might wonder why bother?
But amassing numbers of injured is the only way the agency can “see” what is going on.
That’s what happened just before it issued its Public Health Notification in 2008 after receiving over 1,000 from nine surgical mesh makers association with surgical mesh for POP (pelvic organ prolapse) and SUI (stress urinary incontinence). See it here.
The warning was updated in July, 2011 here. This time the FDA said mesh complications were “not rare” after a five-fold increase in adverse event reports.
“The FDA is issuing this update to inform you that serious complications associated with surgical mesh for transvaginal repair of POP are not rare. This is a change from what the FDA previously reported on Oct. 20, 2008. Furthermore, it is not clear that transvaginal POP repair with mesh is more effective than traditional non-mesh repair in all patients with POP and it may expose patients to greater risk. This Safety Communication provides updated recommendations for health care providers and patients and updates the FDA’s activities involving surgical mesh for the transvaginal repair of POP.”
HOW TO REPORT AN ADVERSE EVENT
So how do you report? Here is a story from August 2014.
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.