I’ve written about transvaginal mesh so many times I feel like a broken record. But it’s still an issue affecting tens of thousands of families and will continue to be an issue as long as that infernal implant keeps being sold and the manufacturers keep refusing to do right by the families that have already been hurt by them.
Yesterday, the FDA announced:
The U.S. Food and Drug Administration today issued two final orders to manufacturers and the public to strengthen the data requirements for surgical mesh to repair pelvic organ prolapse (POP) transvaginally, or through the vagina. The FDA issued one order to reclassify these medical devices from class II, which generally includes moderate-risk devices, to class III, which generally includes high-risk devices, and a second order that requires manufacturers to submit a premarket approval (PMA) application to support the safety and effectiveness of surgical mesh for the transvaginal repair of POP.
On the surface, this is quite a victory, and it may mean the end for many of these implants.The requirements for a “class III” premarket approval device are far stricter than those for the “class II” medical devices.
As I wrote several years ago, that “class II” status was a big reason why the transvaginal mesh health debacle happened in the first place:
Highly similar surgical meshes have been used by surgeons to repair hernias and other abdominal issues, and so the FDA allowed the use of those meshes for pelvic repairs, including when implanted into the vaginal wall, without first requiring controlled human studies. This loophole — called the “510(k) clearance” — has been sharply criticized by the Institute of Medicine, which has recommended eliminating the “510 (k) clearance” program entirely. Those studies would have likely revealed the problem before the surgical meshes were implanted in over 70,000 pelvic and vaginal wall procedures a year.
With the “class II” status gone, the mesh manufacturers can no longer use that loophole. But the FDA left open a pretty big loophole themselves, as revealed in the FDA’s discussion of the orders in the Federal Register, which includes this:
Surgical mesh for indications other than transvaginal POP repair is outside the scope of the 513(e) proposed order and this document. In the 513(e) proposed order (79 FR 24634 at 24636), FDA stated that this proposed order does not include surgical mesh indicated for surgical treatment of stress urinary incontinence, sacrocolpopexy (transabdominal POP repair), hernia repair, and other non-urogynecologic indications.
In other words, this new order by the FDA applies only to meshes that a manufacturer tries to sell “to repair pelvic organ prolapse (POP) transvaginally, or through the vagina.” If a manufacturer leaves that part off, and sells the exact same mesh for implantation through the abdomen, or the exact same mesh for stress urinary incontinence, then — viola! — the manufacturer doesn’t have to meet the strict requirements of “class III” premarket approval.
That giant loophole comes in spite of the FDA admitting on its own website that, when it comes to transvaginal mesh used for stress urinary incontinence, “The safety and effectiveness of mini-slings for female SUI have not been adequately demonstrated,” and “The FDA conducted a review of Medical Device Reports (MDRs) received from Jan. 1, 2008 through Sept. 30, 2011. During this time frame the FDA received 1,876 reports of complications associated with surgical mesh devices used to repair SUI.”
Sound like a lot? It was the tip of the iceberg. I went to the FDA’s “MAUDE” database and searched for “Event Type: Injury” caused by “Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator” and “Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Female, Mini-Sling” and found 391 injuries reported in the last month. I can’t search for longer timeframes than that because the FDA’s website tells me it can’t handle more than 500 results at a time.
Worse, the FDA admits in the Federal Register that this partial victory came as a result of “a meeting on September 8 and 9, 2011 (76 FR 41507, July 14, 2011) of the Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee.” (You can read the documents from that meeting here.) In other words, it took the FDA 4 years, 3 months, and 26 days from that “meeting,” in which a broad array of experts discussed how awfully dangerous and appallingly untested transvaginal meshes were, to decide that manufacturers should be required to produce real scientific evidence about the safety and effectiveness of one particular type of transvaginal mesh when it is used in one particular way.
For comparison, it took 3 years, 8 months, and 26 days from the bombing of Pearl Harbor to the end of World War II.
That’s not the only area in which the FDA drags its feet when it comes to medical device manufacturers. The FDA does little about manufacturers failing a whopping 87% of the time to perform studies on medical devices already on the market. Forbes magazine, hardly a foe of big business, called this a “bait-and-switch with the FDA.” But when there’s money to be made, the FDA is remarkably efficient: as reported in the New England Journal of Medicine, the FDA “evaluat[es] nearly all new drug applications within 6 to 10 months,” approving virtually all of them. (Read more about this problem, and how Congress is trying to make it worse, in this post of mine.)
As my colleague Joe Kramer said, “Once again, device manufacturers are showing that unless compelled to action by the FDA, they will not respond to the plight of their consumers.” Indeed. It seems the device manufacturers don’t care much for juries or courts either, as reflected by an article in last week’s Legal Intelligencer, where the title says it all: “Pelvic Mesh Win Doesn’t Indicate Swift Global Accord.”
It’s foolish to ask, “how many hurt women is enough?” or “how many jury verdicts are enough?” This will keep going on until the companies think it is costing them more money than they are making, and perhaps even longer still.