FDA updated hernia surgery ref mesh

[William Bryant]

https://www.medtechdive.com/news/fda-safety-surgical-mesh-hernia-repair/687949/

As regular posters will know I’m not best at understanding these but it seems to me:-

FDA found after looking at 55000 reports

Pain – 0.3 up to 68 percent
Pain that seriously impacted life up to 3.8 percent

Perhaps some more intellectual posters can analyse it.

It also reveals bd is facing 33000 claims the hernia product. And that bd paid 4.8 million dollars to a patient who had ventralex last year.

How much profit does mesh generate if these payouts can be weathered?

[Good intentions]

Thanks for posting that William Bryant it is very interesting. I clicked through to the FDA links and see that the FDA has updated their “Surgical Mesh Used for Hernia Repair” page as of 7/13/23. They have finally removed the disingenuous focus on the recalled mesh as the cause of mesh problems.

https://www.fda.gov/medical-devices/implants-and-prosthetics/surgical-mesh-used-hernia-repair

But, overall, they do not appear to be planning to take any action to make things better. All that they are doing in their other report is reporting the state of the situation, ending their “Surgical Mesh for Hernia Repair: FDA Activities” report with a weak statement implying that the 3.8% impact on quality of life is acceptable and not worthy of action. Even though the bulk of their report describes how widely varied and of poor quality the data is. Basically, the data is of such poor quality that they can’t tell what is going on so they will do nothing. Unfortunately, in America today, that is typical of a government bureaucracy. Leaving the impetus for action up to the consumer, and the litigation, and whatever moral obligations the medical device company executives feel.

https://cacmap.fda.gov/medical-devices/surgical-mesh-used-hernia-repair/surgical-mesh-hernia-repair-fda-activities

“…
The definition of chronic pain in the studies varied, which resulted in a wide range of incidence (0.3-68%). However, the incidence resulting in significant impact on quality of life does not exceed 3.8%.

Although barrier coated and hybrid meshes were involved in the majority of adverse events reported to the FDA, the literature did not report a significant difference in barrier coated and hybrid meshes compared with other hernia meshes.
…”

[William Bryant]

“Although barrier coated and hybrid meshes were involved in the majority of adverse events reported to the FDA, the literature did not report a significant difference in barrier coated and hybrid meshes compared with other hernia meshes.”

You’d think at the very least it would be worth following up to see if it is a widespread problem.

Shocking that it isn’t.

[pinto]

BTW, William, a great find—thank you— but how on earth can this FDA “info-mercial/factoid” be helpful for patients? First I was pleased that this FDA document primarily addressed patients but it seems more directed toward the basic info about terminology rather than the results of surgery, particularly post-op complications. Yeah such is listed but everything but the kitchen sink. How can the long list of complications be weighed realistically and comparatively to other kinds of medical surgeries?

It seems to me it’s like they announce these complications and then patients are on their own. The FDA has done their duty? But have they just by listing complications? No real guidance is given how this information can be weighed. And actually what patient who has already googled the topic of hernia surgery has not already seen mentions of such complications?

Seems the FDA serve their own purpose rather than patients by seemingly being able to say, “we told you so,” in so many words? Maybe I’m being overly critical of the FDA, so I’d be happy to hear otherwise. Thank you.

[Author]

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