Damage on the fast track
If your doctor ever says he has great news about a “new treatment,” you know it’s time to go on high alert.
“New treatment” translates as “new and untested.” In other words, you’re in for the guinea pig treatment.
Statin drugs were once a promising new treatment. Until patients started experiencing muscle damage, type 2 diabetes, cataracts, etc.
There was even a time when Vioxx was a promising new treatment for arthritis pain. Until patients began succumbing to heart attacks in droves.
More recently, women with poor bladder control received great news about a promising new surgical option.
But it’s just another example of “new” and “promising” turning to disaster.
Taking the long, slow phase-out
It seems I ask this question 100 times each year. “FDA? WHAT were you thinking?”
Really…this is ridiculous. The agency gave fast-track approval for surgical mesh to treat poor bladder control and pelvic prolapse (POP). But soon, many women were suffering. And then, right on schedule, official warnings began rolling in.
Four years ago, the FDA informed consumers of “complications” linked to surgical mesh to treat bladder control and POP. The agency received more than 1,000 reports in three years.
- Vaginal scarring
- Mesh erosion
- Pain and discomfort
- Urinary problems
- Recurrence of incontinence
Some of these problems clearly reduce quality of life. Especially in cases where follow up surgeries are required. And some women actually need second and third additional surgeries.
All of that is bad enough, of course. But here’s the kicker. These problems occurred in about one in ten patients who received surgical mesh for POP and bladder control.
With horrendous results like that, it’s been all downhill since 2008. An FDA warning in 2011 cautioned that traditional surgery (with stitches instead of mesh) was safer and less painful.
Finally, earlier this year, the agency ordered six companies that make surgical mesh to begin safety and effectiveness research.
At this point, I’d like to ask FDA officials one simple question. “Does it EVER occur to you that you do these things completely backwards?”
These studies should have been required eight years ago!
When the FDA called for research, executives at Johnson & Johnson (one of the mesh makers) glimpsed the future. And the future did not look good. So they waited six months. Then, a few days ago, they announced that they’ll “phase out” four mesh products.
But it’s not a recall! No. Don’t use the “R” word! According to J&J, the discontinuation of the products is due to “changing market dynamics.”
Riiiight. Market dynamics. I believe that’s code for “product liability lawsuits.” And there are plenty of those, on both the state and federal levels.
Come on, FDA! This is a debacle! Women are in harm’s way!
Tell J&J they can’t have their phase-out. Shut down these mesh procedures now. Women have much better options for regaining bladder control without the risk of trashing their quality of life.
“Company halts surgical mesh sales after News 8 investigation” WFAA and The Associated Press, 6/5/12, wfaa.com
“Urogynecologic Surgical Mesh Implants” FDA, 1/4/12, fda.gov
“FDA Public Health Notification: Serious Complications Associated with Transvaginal Placement of Surgical Mesh in Repair of Pelvic Organ Prolapse and Stress Urinary Incontinence” FDA, 10/20/08, fda.gov