Mesh / Medical Device News Desk

Oct 19th, 2011 | By | Category: Welcome- Why We're Here

Thanks for stopping by.

Many years from now the public will probably look back and say “They put permanently implanted medical devices in people without any scientific review for safety? ” By then it may seem a perfectly normal question, but for now, Mesh/Medical Device News Desk (MDND) is devoted to telling the stories of the Faces Behind the Adverse Events, complications, injuries and deaths from the implantation of synthetic medical mesh for hernias, pelvic organ prolapse and incontinence.

The truth is- no one really knows what the complication rate is. That’s because there is no tracking after surgery. It’s only when you put a face on the growing number of folks with “adverse events” that the enormity of the problem becomes apparent.  Injured patients are tired of suffering in silence and with the July 13th FDA notification as backing they’re finally joining a chorus of voices of others with complications asking How did this happen? and crying out for both information and regulation.

What’s the problem?

Whether a systemic reaction – a sort of host response, a materials breakdown, or the biokinetics of having a hard piece of plastic implanted in soft tissue and bone, all sorts of adverse events are being felt by mesh patients, both women and men. If you haven’t had a negative reaction- congratulations! No one wishes that upon you but the fact that a) there is no premarket scientific review for mesh and b) no one really knows the adverse event rate since followup is not required and c) mesh has been aggressively marketed to doctors and patients as a new and improved solution, and you have the perfect storm of an ideal population group, large profits, and little to no regulation.

And while injured citizens have brought about two FDA public health notifications about adverse events, the FDA continues to be bashed about the head by the medical device industry that says get off my back, by venture capitalists who say they will launch new devices overseas first because of a restrictive regulatory environment in the U.S., and lately by some in Congress who hope to “reduce regulatory burdens” on medical device makers.

How will the FDA respond to this pressure?

Given the industry influence will it be able to increase much-needed patient protections?  An expert panel that gathered in early September 2011 to try and understand a five-fold spike in devastating complications will decide whether or not to make surgical mesh a Class III device, which means finally some premarket testing and regulation.

I appreciate the conversations and the intelligence of the readers have become very smart out of necessity and pain. The passion and commitment many bring to this perfect storm of patient injury is amazing!

Thank you for joining in the conversation! Your email addresses will not be visible and I WILL NOT share them with anyone unless I ask you first!! Promise!!

Information contained is not intended to substitute for a conversation with your doctor or lawyer. Information belongs to Independent News Group LLC and permission is needed to reproduce but certainly not to link!

Thank you,

Jane Akre, News Editor MDND

 
THE READING ROOM

Resources – Where to Start and What you need to advance your knowledge about surgical mesh

SUPPORT GROUPS

Support Groups/ guidance to lawyers, doctors- The following are groups of mesh injured patients who share a tremendous amount of information out of necessity and pain.

TVTNo.org, a newly formed nonprofit organization to help women find resources. Donations are welcome! Established by Teresa Sawyer, a mesh victim, and her husband David.
http://tvtno.org/

Mesh Medical Device News Desk
http://meshmedicaldevicenewsdesk.com

MDND FB group
http://www.facebook.com/groups/142368339207055/

MDND FB Page
http://www.facebook.com/pages/Mesh-Medical-Device-News-Desk/108924532565482

Medical Mesh Legal Support
http://www.facebook.com/groups/209955715772164/

TVT-No Mesh Survivors
http://www.facebook.com/groups/158270334301550/

Links on Mesh
http://www.facebook.com/groups/412960308757497/permalink/425718040815057/

SurvivingMesh
http://www.facebook.com/SurvivingMESH

National Meshoma Foundation – Bruce Rosenberg 1-954-701-5094- Rosenberg patient advocate advocating for men injured by mesh for hernia repair

TVT Mum- UK site for mesh injured patients
http://www.tvt-messed-up-mesh.org.uk/

Meshies United Group – UK
http://www.meshiesunitedgroup.co.uk/

Meshed Up- European Union site for mesh sufferers in The Netherlands
http://www.meshedup.eu/

Change.org- Petition for Accountability by Mesh Device Companies
http://www.change.org/petitions/fda-and-us-supreme-court-accoutability-of-med-device-companies-injurydeath-from-their-products

Earl’s View – Earl Stevens Blog on Artificial Hip Medical Devices
http://earlsview.com/hip-hell/

Australian Woman’s Facebook page on Mesh
http://www.facebook.com/POPSurgicalMeshMuster

*! Be Aware of any Health Resource that may be solely sponsored by industry alone

FDA

October 2008- Medical Device Alert and Notice, October 20, 2008 – This was the first FDA Public Health Notification about complications associated with surgical mesh used to treat pelvic organ prolapse (POP) and stress urinary incontinence (SUI).
http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/PublicHealthNotifications/ucm061976.htm

July 2011- Alerts and Notice, July 13, 2011 – This was the second notice – FDA Safety Communication: UPDATE  on Serious Complications Associated with Transvaginal Placement of Surgical mesh for Pelvic Organ Prolapse,
This is a much more strongly worded caution about surgical mesh questioning whether benefit is worth the risk, but falls short of a recall. See symptoms the FDA has received from its adverse event database here.
http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm262435.htm

FDA White Paper on Mesh, July 2011, an excellent summary
http://www.fda.gov/downloads/medicaldevices/safety/alertsandnotices/UCM262760.pdf

How to Post an Adverse Event with the FDA
http://meshmedicaldevicenewsdesk.com/?p=569

Institute of Medicine, July 29, 2011 – One hour briefing public discussion following a special independent report on the FDA’s 510(k) approval process
http://www.tvworldwide.com/events/iom/110729/globe_show/default_go_archive.cfm?gsid=1730

The IOM Report, July 29,2011 – The report calls the 510(k) process which allows high-risk medical devices onto the market with no clinical trials “fatally flawed www.iom.edu/510kprocess

PROFESSIONAL GROUPS

American College of Obstetrics and Gynecology (ACOG) & American Urogynecological Society (AUGS) – Both professional societies issued a Joint Recommendations, November 21, 2011, that the use of synthetic mesh placed vaginally for the treatment of pelvic organ prolapse “should be reserved for high-risk women for whom the benefit may justify the risk.”  The groups urge a national registry to track outcomes after placement.

http://www.acog.org/from_home/publications/press_releases/nr11-21-11-2.cfm

Patient POV
Reporter Laura Newman reports on the medical industry from the patient point-of-view.
http://www.patientpov.org/

CITIZEN ADVOCACY

Public Citizen- issued a petition July 2011 to have synthetic surgical mesh recalled from the market.

Press release:
Source: http://www.citizen.org/pressroom/pressroomredirect.cfm?ID=3405

Petition here:
http://www.citizen.org/documents/Petition_to_Ban_Surgical_Mesh_for_Transvaginal_Repair_of_Pelvic_Organ_Prolapse.pdf

Dr. Lewis Wall- Washington University
http://www.citizen.org/documents/wall_statement_on_POP_mesh_petition.pdf

Dr. Daniel Elliott  – Mayo Clinic
http://www.citizen.org/documents/1963-Elliott_statement_in_support_of_HRG_petition.pdf

Consumers Union- November 15, 2011, In a letter to Congress, Consumers Union urges medical device oversight and a rigorous review by the FDA for implantable medical devices so they do NOT get approved by the 510(k) process. Also calls for a issued a call for a patient registry and removal from the predicate list any device that has been recalled.
http://www.consumersunion.org/pub/core_health_care/018231.html

Consumers Union – Safe Patient Project
http://safepatientproject.org/topics/drugs_and_medical_devices/medical_device_safety

WEB SUPPORT/ DISCUSSIONS

 Topix- Hernia Mesh Patch Recall
http://www.topix.com/forum/news/prweb/TE4DF83JKBNACOFNO/p229

Topix- Marlex Hernia Mesh Patch
http://www.topix.com/forum/news/prweb/T9PBVQ8O787R0LGG9/p4

Topix- Lawsuit filed GyneCare TVT
http://www.topix.com/forum/com/jnj/TTE0RAIRMP5EFC052/p127

Topix- Injured by Ethicon’s Prolene Hernia/ Bladder Mesh?
http://www.topix.com/forum/com/jnj/TVQK8627JBUIMHH31/p7

Topix- Ethicon Suture Recall
http://www.topix.com/forum/com/jnj/TG70DTQNSGV1MQQFO/p2

Mesh News Desk- About Us Page
http://meshmedicaldevicenewsdesk.com/?page_id=102

Earl Stevens Blog on Artificial Hip Medical Devices
http://earlsview.com/hip-hell/

Diane Fichter’s Blog
www.imallmeshedup.wordpress.com

 

 

 

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4 Comments to “Mesh / Medical Device News Desk”

  1. Stephanie says:

    Us women and men need someone to put this in news papers and on news all over the world maybe then we can get something done to stop this madness

  2. Jane Akre says:

    Hi Stephanie-

    It is amazing to me that there is not more news about this! I think the media sees the lawyer advertising and just writes it off but there are real injuries of real people from all age groups suffering life-altering complications. Let’s raise the profile!

  3. Meshmessvictim says:

    Christine Scott and her husband Roy accomplished something that had NOT yet been done in this country,SINCE the new products had been released.They won , they beat Bard in court. $5.5 Million dollar verdict, YET I must search high and low to find the story. Why is not 5 o’clock breaking news, I will tell you why. Media outlets are given Shooosh money.This shoud have been on every channel, every website, we need to get the word out. COME ON PEOPLE , WOMEN ARE DYING OR BEING PERMANENTLY DEBILITATING INJURIES, AND YET WE REMAIN SILENT. OR WANT TO SWEEP MS. SCOTTS VICTORY UNDER THE RUG.I HAVE SPENT THE DAY WRITING TO EVERY NEWS OUTLET I CAN THINK OF, MAKING SURE THEY KNOW THE BREAKING NEWS.

  4. Kathy Sabatino says:

    Please let me know if/how I can help. I live in San Francisco, CA and I had the Ethicon Prolene mesh put in me via laparoscopic surgery in July 1994. I knew something was very wrong as soon as I woke up. I was in terrible pain and couldn’t pee and yet they sent me home. I had internal bleeding and came back the next day to be checked back in the hospital. I went on to have pain for years. I was convinced that I needed a hip replacement due to my constant groin pain. I asked every doctor if the hernia repair (in the same spot) could be related and I was almost laughed at. After having a hip replacement and still in pain I was put on heavy drugs and treated as if I were crazy.
    In 2011 I had the infected mesh removed. It had become tangled around my bladder and caused many problems. The doctor also removed many sutures used to tack the mesh down.
    Why won’t the FDA listen?
    I have tried to report this every 6 months and I get transferred around and told, “we haven’t heard of such a problem”.

Leave a Comment

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.