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Have You Filed Your FDA Adverse Event Report Concerning Surgical Mesh?

maude report nov 2014MND, November 17, 2015 ~ This woman did one year ago.

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.

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:

Maude, the tv show NOT the FDA

Maude, the tv show NOT the FDA

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.

 

3 Comments

  1. Susan says:

    Hi Jane,

    How do I find out exactly the name and brand of my two implants? The first implant was for a POP “Vaginal Mesh Uphold” with tape arms?? I don’t know what that means. Only that it’s very painful.

    The 2nd implant was a Vaginal Mesh TVT sling uphold. They were both implanted at the same time.

    I DO know both products are from the same manufacturer ALTHOUGH I am unable to disclose the name of said manufacturer and I also cannot identify the serial #’s on the copy of the paperwork I received on the products that were implanted into my body to know specifically the exact name of each product.

    How do I get this information? Is there a way for me to find out?

    I have now had TWO horrendously painful surgeries with complications for removal of both horrific products that have destroyed my life.

    The first removal surgery was unsuccessful and only ended up being a “revision” of the TVT Sling and basically little to no luck in the uphold mesh being removed. (Too much damage caused.)

    The 2nd surgery to remove both was FINALY a COMPLETE Removal of both.

    THANK GOD!! Original time of that surgery was supposed to be 2 hours although because of the extent of injury it took just over 4 hours.

    I’m still in recovery and in serious pain.

    Both surgeries were the worst experiences and most indescribable pain I’ve EVER HAD TO ENDURE. As well as not being able to release my bladder on my own for app. Two weeks. Along with constant chronic, daily pain and Dibilitating effects of the original implants themselves. My original POP MESH & TVT MESH implant surgery was in 2010 and caused serious nerve damage & horrendous scar tissue build up. I’ve been completely ruined ever since.

    I went to FOUR different Specialsts that refused to even touch my case in fear of my possible bleeding out/death or even worse damage.

    I finally found an amazing and most qualified surgeon thatbwas willing to perform the complete removal and the surgery was a success. Can’t guarantee I will not still have any pain since I do have the nerve damage but at least that horrible product is finally out of my body.

    Now I have even more medical bills to stack up on top of the others from over the years. :/

    I am with a firm that DID receive a “settlement offer” from the Manufactureer “that I am unable to disclose.

    BUT…. My husband had lost his job of 23 years in 2009 and we were forced to file a ch 7 bankruptcy in Dec. of 2011. It was closed and discharged in March of 2012.

    In June of 2012 a family member had informed me of the mesh lawsuits since my pain was worsening and I was unable to work or even live my normal, active & healthy lifestyle.

    With much encouragement I did retain a lawfirm to enter into the mesh lawsuit in June of 2012, 3 1/2 months AFTER my husband and I were discharged from our chapter 7. I filed intonthenmeahinto lawsuit without even knowing if I had qualifying mesh products.

    I was eventually told they both in deed did qualify.

    It wasn’t until July of 2015 that I was told my lawfirm for the mesh lawsuit had received a “settlement offer.”

    They would keep in touch as to what I should expect.

    I then received a letter in Oct. 2015 that I would in fact be receiving a settlement check. “Not what it SHOULD have been but, something is better than nothing… Right?

    Anyway… I filled out the paperwork/book of confidentiality, signed & returned on time.

    I then was informed that I would receive the “net amount” after all FEES were disbursed “more than what I was initially told about.” The “Net Amount would not be known until I received my settlement off check and the itemized list of expenses.

    I was initially told that my ch 7 would NOT effect my settlement since it had nothing to do with my mesh claim.

    Well, to my surprise and ANGER I received a letter 2 days before Christmas “while fresh out of my second removal surgery” that the bankruptcy court filed a motion to reopen my bankruptcy case from 2011 to take my settlement $$ and disburse to debtors.

    I have now retained a lawyer to battle this for me. I have so many Dr., ER & Hospital bills I can’t even see straight & was counting on that settlement that I was promised to receive by 1st week Jan. 2016.

    Soooo, my reason for explains all this is to warn all women out there that have been forced into bankruptcy in earlier years that if you DO receive a letter stating you WILL get a settlement check to go ahead and get a lawyer because the bankruptcy court WILL take it from you no matter how long it’s been discharged and closed.

    I didn’t even KNOW about the mesh lawsuits at the time of filing ch 7 let alone plan to enter into one.

    They don’t care. If you were implanted BEFORE you file bankruptcy… They WILL reopen your bankruptcy case to seize your mesh injury settlement $$.

    So, everyone please be warned.

    A Very Frustrated, Angry & debilitated woman that has lost her quality of life and life in general thanks to this horrific product.

    Please warn all about this.

    Thank-You

    Susan

    • Jane Akre says:

      If you have receive a settlement offer you should know the manufacturer. That is information your law firm has and should supply as well as it being on your records. Could you give the name of the explant surgeon you like so much? Thank you.

    • Linda says:

      Hi Susan,
      Can you give me the Dr name who did the completed removal of your mesh?
      I had a partial mesh removal surgery in May because I couldn’t find a Dr who wanted to do a complete removal.
      Thank you,
      Linda

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