Happy Anniversary Food and Drug Administration - Now What?

July 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

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

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

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? #