Mesh Makers Who Received FDA Letter Requiring Postmarket Surveillance

Jan 9th, 2012 | By | Category: FDA

Prolene Mesh

JANUARY 9, 2012 ~ The following is a list of the companies who received the letters from the Food and Drug Administration (FDA) January 3, 2012, requesting three years of followup studies on the complications associated with synthetic surgical mesh used for pelvic organ prolapse and stress urinary incontinence.

This is unprecedented in that the FDA has not required mesh makers to conduct any studies on safety and efficacy either prior to marketing or afterward. See the background story here.  

See a PDF link to two letters:

 

Letter -  POP 522 Order – final – generic (2)-3 (pdf)

Letter -  SUI 522 Order – final – generic (2)-1 (pdf)

FDA issued the following orders for Postmarket Surveillance Studies:

    • 88 orders for postmarket surveillance studies to 33 manufacturers of urogynecologic surgical mesh for POP.
    • 11 orders for postmarket surveillance studies to seven manufacturers of single-incision mini-slings for SUI.
    • All manufacturers will be required to submit study plans to the FDA that address specific safety and effectiveness concerns related to surgical mesh for POP and single-incision mini-slings for SUI devices. Data from these studies will enable the agency to better understand these devices and their safety profiles.
  • Manufacturers that received the order(s) are listed below:

Pelvic Organ Prolapse

ACELL
AMERICAN MEDICAL SYSTEMS INC.
BIO-VASCULAR INC.
BOSTON SCIENTIFIC CORP.
BRENNEN MEDICAL INC
C.R. BARD INC.
CALDERA MEDICAL INC.
COLOPLAST A/S
COOK BIOTECH INC.
COUSIN BIOTECH S.A.R.L
CRYOLIFE INC.
ETHICON INC.
GFE MEDIZINTECHNIK GMBH
HERNIAMESH SRL
KENSEY NASH CORPORATION
MACROPORE BIOSURGERY INC.
MAST BIOSURGERY INC.
MPATHY MEDICAL DEVICES, LTD
NEOMEDIC INTERNATIONAL
ORGANOGENESIS INC.
OSTEOBIOLOGICS INC.
PEGASUS BIOLOGICS INC.
PROMETHEAN SURGICAL DEVICES INC.
PROXY BIOMEDICAL LTD.
RTI BIOLOGICS INC.
SHELHIGH Inc.
SOFRADIM PRODUCTION
SYNOVIS SURGICAL INNOVATIONS
TEI BIOSCIENCES INC.
TEPHA INC.
COVIDIAN (TISSUE SCIENCE LABRATORIES PLC)
W.L. GORE & ASSOCIATES INC
XYLOS CORPORATION

 

Mini-slings

AMERICAN MEDICAL SYSTEMS INC.
BOSTON SCIENTIFIC CORP.
C.R. BARD INC.
ETHICON INC.
GYNE IDEAS LTD.
MPATHY MEDICAL DEVICES LTD.
PROSURG INC.

 

  • Please note, these 522 orders do not cover abdominal sacrocolpopexy (ASC) for treatment of POP or Multi-Incision Retropubic or Transobturator SUI Slings

 

 

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14 Comments to “Mesh Makers Who Received FDA Letter Requiring Postmarket Surveillance”

  1. Amy G says:

    unfortunate that this does not address the same issues with the other slings as they are not without significant risk either.

  2. Dear Jane

    Can someone put into plain english exactly what the below means

    ■Please note, these 522 orders do not cover abdominal sacrocolpopexy (ASC) for treatment of POP or Multi-Incision Retropubic or Transobturator SUI Slings.

    Teresa Hughes

  3. Jane Akre says:

    Mrs Hughes- thanks for asking.

    Under the FDA’s Section 522 of the Federal Food, Drug and Cosmetic Act (the act) the FDA has the authority to conduct postmarket surveillance of a class II or class III device if :

    its failure would be reasonably likely to have serious adverse health consequences;
    it is expected to have significant use in pediatric populations;
    it is intended to be implanted in the body for more than one year; or
    it is intended to be a life-sustaining or life-supporting device used outside a device user facility.

    522 gives the FDA a mechanism to order surveillance after a device is on the market (backward isn it?) to see if it is working as promised. The announcement the other day that the FDA was going to order surveillance to mesh manufacturers was a HUGE story because now they must prove the product is not harming patients. Unfortunately since there will be three years of data collection many more will be implanted with synthetic mesh.

    here is a link
    http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMA/pss.cfm

    Here’s another
    http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/PostmarketRequirements/PostmarketSurveillance/ucm134497.htm

    What the reference is saying is that there is no 522 order on the multi-Incision Retropubic or Transorbuturator SUI slings.

    • Jane Akre says:

      HI All-

      I fixed the links to the pdf letters from the FDA to mesh manufacturers!! Now clickable! Thanks for all who noticed.

  4. DJ says:

    It’s absolutely unbelievable and appalling that transobturator slings (TOT’s) are not included and makes NO SENSE AT ALL!!! ALL transvaginal mesh (TVM) can cause SEVERE and permanent injuries and TOT’s are horrible. ALL TVM is inserted using a sharp instrument that bores BLINDLY through delicate pelvic tissue! Surgeons do not use nerve monitoring instruments during TVM surgery to avoid these nerves as is done with other surgeries where nerve damage is possible. AUGS (American Urogynecologic Society) said in a 2009 Webinar for it’s members that even in surgeons “with thorough anatomic knowledge, complications will occur” fromTVM surgery because it is a BLIND procedure! The FDA’s OB-Gyn Panel thought SUI TVM had been shown to be “effective” but agreed that it’s “safety” had not been proven- the difference is that they thought that the complications from SUI TVM were “manageable” in comparison to POP TVM. So, in other words, all of the patients who have been seriously physically and emotionally harmed (tortured) by SUI TVM are apparently expendable in the eyes of the FDA and the OB-Gyn Panel. I am a nurse.

  5. [...] letters asking for three years of post market follow-up on patients with mesh.  (background story here) The task will be for the FDA to act on the results the follow-up reveals and to expand labeling [...]

    • Amy G says:

      A bigger task is getting the surgeons who implant the mesh to even recognize these problems- as mesh erosion is really not considered a serious complications by most and significant pain is almost always attribued to something else-it is unlikely this surveillance will capture the true picture.

      • jane akre says:

        And it gives the makers the benefit of the doubt! Three more years of implants! Why not err on the side of caution- the Precautionary Principle!!!?? Why are medical devices innocent until proven guilty with all the evidence of harm? Just look at our Patient Profiles. Really are there that many bad surgeons out there?

        • Amy G says:

          I read the January 20, 2012 letter from congressman Waxman requesting an investigation into Medical Device approval process that this was their second request. Do you know how to access the October letter?

  6. jane akre says:

    Hi Amy-

    This was the first letter which was apparently ignored from October 2011. They point out metal-on-metal hip implants and brain stents as having problems and ask committee members to consider whether the approval process for these devices could be improved, especially as funding the FDA is an issue coming to a head!?

    Here is the October letter…..

    http://democrats.energycommerce.house.gov/index.php?q=news/energy-and-commerce-democratic-leadership-calls-for-further-examination-of-fda-medical-device-r

    • Amy G says:

      Thanks for posting-disheartening that the October letter failed to illicit a response. I wrote to my rep. Matheson yesterday as he serves on the subcommittee with Rep. Waxman. In reading the letter from 1/20/2012, I am so shocked the lap band is even on the market. The lap-band companies should also be scrutinized for claiming their product treats diabetes….weight loss cures/improves type II diabetes not a plastic band itself–how absurd.

  7. [...] a three-year followup of patients implanted with the controversial medical device. Background story here. The agency also said it was considering reclassifying transvaginal mesh (implanted through the [...]

  8. Angie McKittrick says:

    I had POP AND SUI TVM placed in me during hysterectomy in 2007. Since then I’ve struggled with chronic pain and recurrent infections. Unfortunately, the maker of my TVM is one of these that have been ordered to do studies. How do i get my information to the fda so that my complications are reported and noted during these studies??

    • Jane Akre says:

      Angie- I believe the subjects for post approval monitoring have been chosen by now, more than 2 years after the orders were issued. Could you find someone within your TVM implant company to voice wanting to be part of them. Have you entered the recent FDA proposal to change the classification of mesh? (very important) Have you filed your adverse event with the FDA MedWatch? Apparently they do track that because recently the fDA said there were 19,999 POP injuries over the last two years. That is a HUGE number considering the FDA represents about 1-10% of Actual injuries according to govt. estimates. Contact me further if you want to pursue this with the company..Thanks Angie~ja janeakre@meshnewsdesk.com

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We hope you find this a helpful resource. National News Editor, Jane Akre, began MDND with the hope of providing the latest news, information and perspective from the regulatory, industry and patient point of view, something that goes under-reported in much of the coverage of medical devices. The public is just now becoming aware that many devices do not undergo the same scrutiny as prescription drugs and are instead grandfathered in under an FDA loophole that has gone largely unchanged since the 1970s. As a result, patients become the post-market clinical trial subjects, and many suffer devastating and permanent injuries.