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FDA Pelvic Mesh Data – Are Thousands of Deaths Not Being Reported?

Madris Tomes, Device Events

Madris Tomes, Device Events

Mesh Medical Device News Desk, December 5, 2016 ~ A former FDA IT project manager left the agency to focus on patient safety and the numbers needed for true patient advocacy.

Imagine 5.6 million pieces of data collected by the U.S. Food and Drug Administration (FDA) concerning adverse events, the FDA term for complications.

Yet the agency has trouble identifying early warning signs for thousands of troublesome medical devices.

Madris Tomes, worked at the FDA as an IT project manager in its adverse event reporting program, knew there was a better way of making data useful to consumers, hospitals, doctors and even attorneys.

The fixes being sought by the current programmers to the MAUDE (Manufacturer and User Facility Device Experience) adverse event database used an Oracle-based system. Tomes thought that works for day-to-day data entry, but not for identifying the big picture safety signals.

With 70,000 new adverse events reports coming into the FDA every month,  Tomes knew it was impossible for the FDA to keep up with needed recalls. So she quit the agency two years ago to build her own user-friendly system with Marklogic developers.

She is now the system architect/Founder and CEO of Device Events and she consults with doctors, lawyers, hospitals, consumers, anyone who wants to know what is going on with complication reports registered with the FDA by doctors, hospitals, manufacturers and patients.

In other words, what devices are working in real – life, and which are not.

I knew there were lots of death reports and malfunctions and injuries from medical devices. The data is so dirty, you never see the true scope of any device company,“ she told Mesh News Desk.

 

PELVIC MESH COMPLICATIONS FDA logo 2 200

What do we know about pelvic mesh and its complications?

Well, it depends on how you ask.

And there is no shortage of search terms, which essentially describe the same thing.

To do some practice runs, we used a few terms – “mesh,”  “surgical,”  “polymeric,” “synthetic,” “urogynecologic” “sling,” “pubovaginal,” and “sepsis,” among them.

Running some numbers for Mesh News Desk, Tomes found:

Using the search terms “Mesh” in general, and “Sling” showed 126,349 adverse event reports. And there were 49 recalls. (When J&J pulled its Prolift off the market, that does not qualify as a recall).

“Mesh Surgical” and “Polymeric” yields 66,000 complication reports. How many were deaths?

It’s hard to tell because they are sometimes incorporated into terms like “malfunction” or”injury”.

device-events-appTomes tells MND, “Each company has its own way of saying how a patient died. Use the terms “autopsy,”  “failed to live,” “patient expired,” “injury,” or “malfunction”.  So I created an algorithm to say the way the patient died rather than say ‘death’.”

*Various search terms found 5,900 death reports. The word “autopsy” uncovered another 500 deaths.  

*Put in mesh, “near death,” yields 1,500 deaths from mesh, but only 400 boxes are checked, which could be misinterpreted, she says.  

*The terms can be broken down by company, using “mesh” or “sling” and J&J there were 43,552 adverse events. If you used the term “pelvic” you wouldn’t see that. 

* “Mesh/Sepsis” found 287 AE reports, but you can also look at “perforate” and “rupture” which found 378.

*”Mesh/colon” and “colon removed” found 722 reports and 26 deaths.

* “Tension-free” and “polymeric mesh” found 65,062 adverse events and 18 recalls. Deaths in that group – 281 have death box checked.  

*”Polymeric sling”-  showed 23,392 adverse event reports, 430 deaths. Of those, 7,762 reports came from physicians.  

*”Physiomesh”, the recalled J&J hernia mesh, shows 689 adverse event reports, 9 deaths and two recalls. 

 

THE DOWNSIDE TO DATA

As has been reported in the past, the FDA’s database is not particularly user-friendly or even known to some who work with medical devices. The number of reports coming into the agency represent only about 14 percent of actual real-life adverse events occurring in hospitals, for example, according to a 2012 Office of Inspector General report (here).

Tomes says some reports are redacted by FDA reviews. She doesn’t know why. When looking up a particular super bug, there was a Freedom of Information clause that said it was protected information or HIPPA and the information was redacted. She doesn’t know whether companies tell the FDA to redact information.

“That worries me,” she adds.

Also clouding the true picture of medical devices is that when the FDA adds a new year of data, it removes a year. MAUDE shows the last 10 years, but the raw data goes back 20 years. It isn’t a question of space on the server. The government requires records are kept a certain amount of time, that’s all.

Reports are still not coming in from the Veterans Administration for some unknown reason, she says.

“There is an entire universe out there the FDA doesn’t see.”

Essure, ABC, Tampa

Essure, ABC, Tampa

 

REPORTS COMING IN AND ITS USE

But Tomes admits the reports that are coming in are “scary.”

For example, recently Essure activists asked Tomes to run the numbers and she found 303 fetal deaths from the permanent birth control device. The FDA data had shown only five deaths.

This information was used by Rep. Mike Fitzpatrick and a press release pushing for in legislation to get Essure off the market.

Based on a subscription service, hospitals will be able to use the Device Events reports to find out which devices are yielding the most complications so they do not reorder them.

There was a group purchase of 200,000 Essure devices in June. They weren’t supposed to purchase anymore but the person didn’t know that and put through another order. Once you make a decision, there has to be some way to turn off the mechanism,” says Tomes.

Tomes believes this work is needed now to support true patient advocacy.

“With 70,000 new reports coming in every month, how can a doctor and provider keep up with this? They rely on the FDA, but the agency takes two months to two years to recommend a recall. Rather than wait for the FDA, I’m trying to put the data in front of the public so they can decide.”   ###

15 Comments

  1. janet Holt says:

    A sincere thank you to Ms. Tomes for seeing a huge problem then trying to come up with a solution to make the data more useful for the safety of us all. We have known for some time that the FDA was just this huge black hole with information going into it but no one looking at or compiling the data together. It should not be the responsibility of injured women or men to do their job for them. The FDA should be warning us, the patients, not the patients requesting an advisory panel be assembled so THEY can hear about the harm that has already been done. We have no patient safety from the FDA. The FDA should just come out and say ” patients you are all on your own’.

  2. Anon says:

    Can you please offer a cite for the Inspector General Report that found only 14% of adverse events are reported to the FDA? Thank you in advance.

  3. Kitty K says:

    What a great job Ms Tomes is doing. All power to her. X

  4. Denise S says:

    Great writing Ms. Tomes….as one of the forgotten ones that have had hernia mesh and never listened to even after physiomesh not lasting 2 weeks in me before I had the fever of 102-03… I knew something was wrong in post op, I was told by dr it was post op pain only that I couldn’t feel what the mesh was doing…. yeah right….

  5. Dana D says:

    I had the vaginal, and now my life is a living HELL!! I live with pain 24/7. It has rob me of my marriage, and my life that I once live. I live with medical problems now, but the Doctors don’t know what to do with me. I don’t feel human anymore. People can’t understand my medical problems, because it does not have a name , it does come with a title or a cure. I feel sooo a lone.

    • Still Standing says:

      Dana, pain has a way of making us feel isolated and alone. I think most of us feel that no one can fathom our pain, and actually, they can’t. I had transvaginal mesh in 2008 and seven additional surgeries since then and I know that I will never be able to claim that old self. It is hard to take in, but once you can reach that point, you can do intentional things on a daily basis that help ease your pain. Put enough of those moments together, and you can have some good days. The most important thing you can do is to concentrate on self care. Are you resting enough? An hour down for every two hours up is a good rule. Are you moving around enough ( NOT moving can generate more pain over time because our muscles tighten), are you getting the right nutrition ( pain makes us crave comfort foods..dairy, and sugar the most) and those two are the major foods that drive inflammation. Inflammation causes pain. Are you constipated chronically? If so, do whatever it takes to be regular. Constipation will cause you more pain. Have you figured out what triggers more pain? If not, keep track of when your pain increases and what you were doing. Get to know every aspect of your pain, then communicate in very clear and specific ways to your physician. It is hard for them to know what to do for you if they dont know the details. It can be embarrassing to tell your doctor that your vagina ( yes, you have to say that word)feels like gasoline that has been lit on fire , or that your labia feels stretched, or that you have rectal pain. Be a good historian. This can help your doctor understand your pain and help him or her target some interventions that can help. There are some things we cant change, but small changes can reduce our suffering and that can give us some positive moments in our day. Be good to yourself.

  6. I trained at FDA/CDRH to be a Patient Representative. I learned that the 510(k) required only a predicate device to clear a new ‘innovative’ device for the market. Recently I have attended state and federal medical device trials. The FDA testimony is irrelevant to device safety and effectiveness, yet doctors and their patients rely on this government agency. There is a huge disconnect and the result is unsustainable harm. Thank you Jane Akre and Madris Tomes for this information.

  7. Laura H says:

    Excellent piece, thank you. So many devices are causing so much harm. We need to reboot FDA device policy into the 21st Century and mandate pretesting all device materials for biocompatibility with individual patients before they are installed. There are blood tests for both medical and dental devices.

    • Still Standing says:

      Absolutely. I need cataract surgery but told my eye doctor I will have to beblind before I have anything implanted in me again. I just learned that I have Mastocystitis, a severe and rare autoimmune disease where the body seriously over reacts to triggers…food, scents, fabrics ( I now cant wear any socks with spandex or other elastic. All I can wear is pure alpaca. Summer is a problem because I react to the adhesive in sandals or tennis shoes. It responds by overproducing mast cells and histimine. It causes unpleasant swelling, rash and flushing on my face and for now, on my feet. It can also involve lungs and other organs. I also had to have my two old cavities refilled because I am sensitive to nickel. This is in addition to erosive lichen planus. Just always seems to be one new thing added to the others. So, you are absolutely right and we all need to be very thoughtful regarding any procedures that involve permanently placing any foreign substance in our bodies.

      • Kitty says:

        Lucky u that u can wear alpaca. I can’t get within 10 feet of wool. Very sorry for your other suffering though.

        • Still Standing says:

          Well, that puts a positive spin on not being able to wear shoes with any adhesive, which is basically all shoes. I CAN be grateful that there are a few types of socks that I can wear, especially now that snow and ice are on the midwest scene. Thank you for reminding me to look on the bright side. I need to be reminded of that from time to time.

  8. Disgusted says:

    I don’t know where to post this, so I chose here. I was on another site and a 19 yo was asking about her prolapse. I basically said I agreed with another person who posted an answer and added to stay away from mesh. I said it’s playing russian roulette. I got corrected by other posters who said not to listen to “scary stories”. One of them is the moderator of the site. I don’t know how to respond. One woman even answered saying she has a sling and she thought it might be eroding, but found out she has a prolapse and that was causing the problems, the sling was fine. Don’t listen to fear mongers. This is bothering me. Should I answer or just let it go? Thanks for your consideration. I have been so affected by mesh that I take it very personally.

    • Jane Akre says:

      Wow Disgusted. Please could you let us know what site that is… It might be the one run by Sherri APOPS, Please, that is industry backed and has a history of ousting any alternative opinion.

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