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Happy Anniversary Food and Drug Administration – Now What?

FDA logo 100  2July 2, 2013 ~ Many of you may be aware that the entire pursuit of lawsuits against mesh manufacturers began two years ago this month with the issuance of a safety warning from the U.S. Food and Drug Administration concerning transvaginal mesh.

FDA Safety Communication: UPDATE on Serious Complications Associated with Transvaginal Placement of Surgical Mesh for Pelvic Organ Prolapse (here):

This was the second notice issued by the FDA about  complications associated with synthetic transvaginal mesh. It says:

  • “Surgical mesh is a medical device that is generally used to repair weakened or damaged tissue. It is made from porous absorbable or non-absorbable synthetic material or absorbable biologic material. In urogynecologic procedures, surgical mesh is permanently implanted to reinforce the weakened vaginal wall to repair pelvic organ prolapse or to support the urethra to treat urinary incontinence.”
  •  ”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 the first notification by the FDA issued Oct. 20, 2008.”  See that original notice here which says complications are “rare.”
  • “Furthermore, it is not clear that transvaginal POP (pelvic organ prolapse) repair with mesh is more effective than traditional non-mesh repair in all patients with POP and it may expose patients to greater risk.”
  • “From Jan 01, 2008 through Dec. 31, 2010, the FDA received 2,874 additional reports of complications associated with surgical mesh devices used to repair POP and SUI (stress urinary incontinence), with 1,503 reports associated with POP repairs and 1,371 associated with SUI repairs.”
Where are we now?

Perhaps as many as 30,000 lawsuits have been filed, many of them consolidated in one federal court. Those cases against manufacturer C.R. Bard are about to commence July 8, 2013. Many of the same big-name law firms are involved.  Go to So District of West Virginia and see the counsel listed (here).  The Honorable Judge Joseph R. Goodwin will pull marathon duty overseeing four cases back-to-back against Bard.

Judge Joseph R. Goodwin

Judge Joseph R. Goodwin

So far C.R. Bard lost one case involving its Avaulta mesh in state court in California. Bard and the implanting physician were ordered to pay Christine Scott $5.5 million, however that verdict is on appeal. Back story is here.

In state court in  New Jersey, Ethicon, a division of Johnson & Johnson was ordered to pay plaintiff Linda Gross $11.1 million including more than $7 million in punitive for its defective Prolift mesh. That case too is under appeal. ( see the Facebook and MDND coverage here and here scroll down to February for coverage.)

Linda Gross

Linda Gross

Even though the FDA has not updated its information on mesh for stress urinary incontinence (SUI) those cases continue to amass in court.  In March, the FDA announced its tracking of SUI mesh injuries had increased by 36%, yet the agency has not yet delivered an update specifically on mesh for incontinence. See the MDND story here.

The general consensus is “the more mesh the more mess” and a ribbon of mesh to hold up the urethra was thought to present less of a problem then a larger sheet or kit of mesh for transvaginal placement.  Still many women are suffering the same symptoms such as transvaginal mesh such as erosion, infection, perforation of organs and nerve damage.

Pudendal nerve, YouTube

Pudendal nerve, YouTube

Two years later and not much has changed.  True informed consent for a patient would  includes this FDA Safety Communication intended for doctors and healthcare professionals.

How many patients have been informed about this 2011 FDA warning? #

2 Comments

  1. Dawn says:

    Whether you have a lot or a little ribbon of mesh, the whole body is affected. I had the monarc and if more mesh causes more problems and pain than I experienced… God help them.:( I was living in hell for 3 years with just a small strip of mesh…. My body is now attacking itself , even after mesh removal.

  2. Chadley McVeigh says:

    I have had two hernia mesh repairs. Following a gall bladder removal with complication I did not become aware of until my third post-op visit to the surgeon – I began having complications with the mesh as well. Currently I am seeking funding to repair the left one, an Ethicon Prolene Hernia Mesh Patch. In the last 24 months it has progressed and seems to be continuing to progress in challenges to my life… I cannot walk very far, sit or stand very long. I have pain throughout my groin, hips, lower back and abdomen, genitals and legs. I cannot work. I have sexual dysfunction and pain with sexual activities. I have been accused of having a “somatoform delusion disorder” by the Veteran’s Administration as well as sodomy. Many other have claimed complete ignorance; cited irrelevant data about pain and mental illness; suggested an attempt at fraud and I have been told that new hernia can repair itself and/or is “normal”. I have offered to “let it go” for help to many medical professionals. Few have “stepped out of line” from their boss’s legal department and have said things like “I apologize for my profession” and “you should have been given a choice” and you “need a doctor you can TRUST”… I am of excellent spiritual strength (praise Jesus) and am a happy person despite this terrible condition. This needs to stop for others. That is VERY important…

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