Mesh Medical Device News Desk, June 7, 2016 ~ The FDA has been slow to act and react to mesh complications.
Be sure to make your report to the agency so it has the ammunition it needs to act.
The first warning came from the U.S. Food and Drug Administration (FDA) in 2008. The watchdog agency issued a The Public Health Notification (here) after it had received numerous complaints from women who were implanted with polypropylene pelvic mesh to treat stress urinary incontinence (SUI) and pelvic organ prolapse (POP).
The first FDA Safety Communication said mesh complications are “rare” and include mesh exposure through the vagina, pain infection, bleeding, pain during sexual intercourse, organ perforation and urinary problems as well as recurrent prolapse, nerve and muscle problems, vaginal scarring and shrinkage and emotional problems as a result.
This report was issued after the FDA received over 1,000 adverse event reports.
But by January 2008 through the end of 2010, the number of injury complaints increased three fold. “Although it is common for adverse event reporting to increase following an FDA safety communication, we are concerned that the number of adverse event reports remains high,” said the agency.
What was significant was by July 13, 2011, the FDA had amassed so many complaints that the agency reversed its warning.
In FDA UPDATE on Serious Complications Associated with Transvaginal Placement of Surgical Mesh for Pelvic Organ Prolapse, this second notice said complications associated with mesh used for POP repair are “not rare” (here).
The FDA, in its second warning, identified mesh used for POP repairs a particular culprit and one that “introduces risks not present in traditional non-mesh surgery for POP repair.”
Earlier this year, the FDA moved (here) to reclassify POP mesh, the larger polypropylene mesh used to shore up a sagging uterus or colon as a higher risk Class III. It gave mesh manufacturers 30 months to prove their mesh is safe or take it off the market. In the meantime it can still be used. See the background story here.
Health Canada followed the U.S. lead and in February 2010 also issued a warning to consumers. See it here. Most patients receiving so-called “informed consent” from their doctors prior to receiving mesh, were never told that these warnings even existed.
Hernia mesh does not have any similar warnings even though it is the same polypropylene and even though the complication reports coming into Mesh News Desk are remarkably similar.
Mesh for SUI or incontinence remains on the market without that special warning. It is a class II device and does not require any clinical trials proving safety or efficacy before it is sold to doctors. That is notable since there are more lawsuits filed over injuries caused by SUI mesh, probably because it is more commonly used than POP mesh.
WHY IT’S IMPORTANT TO REPORT AN ADVERSE EVENT TO THE FDA
So how do you report to let the FDA know you are not alone? The only way the agency can act is if it knows bout your report and it sees complaints trending upward. So reporting ANY mesh complications, transvaginal, abdominal and hernia mesh, is very important.
When Scottish mesh survivors spoke to a parliamentary committee, they got changes imposed. As far as the report your doctor submits, please check it for accuracy. Sometimes the conclusion written is inconclusive after it has passed through a rewrite. Please check the report your doctor submits to make sure it reflects your true story. You can also report on your own.
If your lawyer reports the event, it may not be taken as seriously as we saw when the FDA calculated reports on trocars to consider reclassifying them. See background story here.
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.
Or you or your doctor could report directly to the Manufacturer and User Facility Device Experience (MAUDE) database on medical devices that have caused injury.
Here is the database:
The FDA’s MAUDE database is not easy to figure out. You would not call it user friendly. You will need your medical records to find:
- Manufacturer’s name
- Product name (brand name)
- Catalog number
- Lot number
- Date of implant
- Date of explant (if mesh was removed)
- Details of the adverse event and medical and/or surgical interventions (if required)
- Type of procedure (e.g., anterior or posterior repair, sacral colpopexy, sling procedure for SUI)
- Surgical approach: (e.g., vaginal, abdominal, laparoscopic)
- Reason for mesh implantation: (e.g., POP of the uterus, bladder, rectum, vaginal apex or bowel, SUI)
- Specific postoperative symptoms experienced by the patient with time of onset and follow-up treatment
Here is what one woman entered into MAUDE for her pelvic mesh implant injury.
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.
One telling factor is that the FDA says it takes the “least burdensome approach to regulating.” That’s right! The “least burdensome” on the manufacturers, not on you, the end recipient of the devices they oversee. Here is the language from the FDA:
The Least Burdensome Approach
“We consider the least burdensome approach in all areas of medical device regulation. This guidance reflects our review of the relevant scientific and legal requirements and what we believe is the least burdensome way for you to comply with those requirements. However, if you believe that an alternative approach would be less burdensome, please contact us so we can consider your point of view. You may send your written comments to the contact person listed in the preface to this guidance document.” Read about Least Burdensome on the FDA website here.