Mesh Surgery- What is a Qualifying Procedure?

Mesh Medical Device News Desk, March 13, 2019~ For those women with a "Mesh in Place" that is no revision, there is a way to stay in the pelvic mesh litigation.

What is a Qualifying Procedure?

Last year, a federal judge overseeing the multidistrict pelvic litigation mesh moved to dismiss hundreds of cases of women who had not undergone a Johnson & Johnson (Ethicon) mesh removal surgery.

These are known as “mesh in place” cases and Ethicon wanted them removed from the docket stating they should no longer have a claim. At its height, the federal court in Charleston, West Virginia was home to more than 104-thousand pelvic mesh cases filed against seven manufacturers.

Since 2012 when the multidistrict litigation was filed (MDL), cases have slowly been dropped from the court as they settle or go to trial.

Ethicon, which had more cases than any other manufacturer (40,545) no longer wanted to settle mesh in place cases for the products it still has on the market - the Gynecare TVT products including TVT and TVT-O, Abbrevo and TVT Exact. The J&J motion was granted by Judge Goodwin.

See Pretrial Order  #293 in Ethicon MDL 2327.

Why leave a controversial mesh in place?

Some women were unable to have polypropylene pelvic mesh removed - maybe she could not undergo surgery, maybe she could not afford surgery, or maybe a doctor told her she was not a candidate for removal. Also some women with no pain initially develop complications later. Regardless, hundreds of women did not undergo mesh removal surgery.

As a result, in July Judge Joseph Goodwin dismissed 500 of those women from multidistrict litigation, leaving the door opening to refile their case if they had something called a “Qualifying Procedure.”

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What is a Qualifying Procedure?

While Ethicon limited refilling a case in the MDL to “medically necessary Revision Surgery," Judge Goodwin broadened the definition of a “revision” surgery, suggesting other qualifying procedures could substitute.

These include:

• Office removal of the mesh, also known as a partial removal. Many mesh surgeons do not suggest a partial removal for various reasons, largely a partial can cause more problems than it solves.  An alternative to a full mesh removal would include more than one office partial revision/removal of the mesh.
• A revision surgery should mean removal of mesh, scar tissue, repair of fistulas and under general anesthesia, regional or MAC anesthesia.
• These patients also need to have accompanying treatments of trigger point injections, vaginal physical therapy, or utilization of vaginal Valium.
• At least six medical records need to have demonstrated the need for these therapies which must be performed by a competent, licensed physician.
• A litigation funding company can have no relationship with the physician or facility performing the procedure or the surgery will not be considered.
• Ethicon agreed that in consideration for allowing her to dismiss her case without prejudice ( it can then be refiled later) procedures must take place within five years of the date of dismissal of her case for it to be a viable case, though Ethicon adds it is not waiving any applicable statute of limitations.
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Trials Ahead in the WV Court

The one remaining case from Wave 7, Ms. A. Sutphin, is scheduled to be tried in Charleston, West Virginia in April. She was implanted with a TVT-O.

Wave 10 Ethicon cases are currently being settled, remanded out of the MDL, or prepared for litigation with deadline exhausted for trial preparation by June 2019. There are 1,256 woman implanted with an Ethicon pelvic mesh currently slated for Wave 10. PTO #320, Ethicon 2327.

Ethicon Wave 11- PTO #328 – Discovery date ends in September of this year and the trials should commence shortly afterward unless the cases are settled. There are 6,557 women listed in Ethicon’s Wave 11.

Exhibit B of Wave 11 is made up of 551 women and includes cases filed against Boston Scientific, Mentor Worldwide, C.R. Bard, Coloplast, American Medical Systems, as well as Ethicon. ###