Vaginal Meshes, originally conceived, perhaps with good intentions, have become quite the source of trouble for the women who opted for these devices to be implanted in them. Years and years of lawsuits, with multiple companies settling and fighting them, would, you think, put a damper on the product, but no! The saga, ensues, and shows no signs of ending!
I came across this bit of news today. Not only is J&J fighting back on a recent judgement against it, the company is going ahead with more clinical trials.
New Design or Brave Face?
The most recent judgement against J&J, is to the tune of $20mn, $17.5mn of which are punitive damages, in Pennsylvania. It makes sense that given the amount and the fact that it is a State verdict, that J&J would fight it.
Part of their reasoning to fight the judgement is that, they believe the Ethicon Design was not flawed. And yet, about 5 years ago, they pulled the product from the market, apparently only owing to the negative publicity (well placed, if you ask me) for vaginal meshes, and not owing to bad design. And, if you read the history, (see link 3 under references below) you will find out the excision of the device from the market (easier than excision from the body) was not exactly voluntary.
Then why redesign the vaginal mesh at all?
And, it is not as if all the negative publicity has gone away. So, why would the public suddenly change their mind now?
In part, I think all this talk about the new design is perhaps, just a brave face effort, to fend off future lawsuits, of which, I am sure, there will be many. If not, it must be the notion that the vaginal mesh will still prove to be a viable device, despite all the hands in the cookie jar, and J&J should not lose the edge. Patents, PMAs and clinical trials after all, create a high barrier for entry to any uppity start-ups that come along with design improvements…
The real culprit
Vaginal meshes treat vaginal prolapse, the collapse of the pelvic vault, and stress urinary incontinence (SUI), arising from muscular dysfunction (loss or impedance of function). Vaginal prolapses, often occur as a consequence of hysterectomies. Quite a significant number of hysterectomies are unnecessary, and are performed in preference to lesser invasive treatments, as hysterectomy is well covered by insurance companies! The hysterectomies, in effect lead to complications, such as prolapse, which then need either surgery or mesh implantation and on and on it goes.
If we reduce the haphazard use of hysterectomies as the nuclear weapon that kills ants, then we automatically improve the chances of preventing and/or delaying prolapse altogether, in which case, you wont have a number of suffering women across the country, lawsuits and incredibly uncouth late night television ads on vaginal mesh lawsuits!
- The J&J Verdict: http://www.qmed.com/mpmn/medtechpulse/jj-will-fight-20m-vaginal-mesh-verdict?cid=nl.x.qmed02.edt.aud.qmed.20170503
- The Mayo Clinic on Vaginal Mesh Complications: http://www.mayoclinic.org/diseases-conditions/pelvic-organ-prolapse/in-depth/transvaginal-mesh-complications/art-20110300
- History, Notes on Complications, etc: https://www.drugwatch.com/transvaginal-mesh/
- Image courtesy, Pexels: https://www.pexels.com/photo/black-microphone-windscreen-158736/