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Last week, we discussed the complications involved with a plastic resin used by C.R. Bard in some of their transvaginal mesh devices – a plastic that was particularly prone to erosion and other complications. (//baronandbudd.com/dangerous-drugs-devices/medical-implants-devices/transvaginal-mesh-lawsuit/)
The obvious question – and one we hear all the time – is: how did this even get on the market?
Blame it on the FDA’s 510(k) system, a system that permits medical devices to enter the market without human testing so long as FDA regulators determine that the medical device in question is similar to a product that has already entered the market. We know – you’re thinking that sounds unethical. After all, when it comes to our health, shouldn’t all products undergo significant testing before they are available for purchase? Well, it’s not that simple.
The FDA’s 501(k) system does have significant value – patients suffering from a disease with limited treatment options, for example, may benefit from this system, and no doubt many products that are approved by the 510(k) without human testing may not require the extra time and cost involved with human testing, as they really are nearly identical to a product that is already on the market. However, we’re talking transvaginal mesh devices here, and that’s a different story.
Transvaginal mesh was approved by the 501(k) system based on its similarity to a product already on the market: a hernia repair. What? You read that right: Transvaginal mesh devices were allowed to enter the market based on their similarity to a product used for hernias, a product intended for a different ailment and body part altogether.
So how could a device used for hernias gain approval for vaginal surgeries without even one test surgery?
It has to do with the classification of the mesh. The FDA ascribes to three medical device classifications based upon an estimation of risk, which in turn determines the amount of required testing.
Class III is for "high-risk" devices which, for the FDA, really means devices intended for "high-risk" treatments such as intraocular lenses or implantable heart valves.
Class II involves "moderate-risk" devices like MRI equipment.
Class I is for "low-risk" devices like wheelchairs or tongue depressors.
Understandably, the FDA requires significant testing for all Class III devices before they are approved to enter the market, meaning manufacturers of these high-risk devices must prove to the FDA that their devices are both "safe and effective." Class II devices require more limited review and testing before the device is approved to enter the market, meaning manufacturers of these moderate-risk devices must only prove to the FDA that their devices are "substantially similar" to a device already on the market before they are approved for sale. Class II devices require no pre-market testing.
Guess which class transvaginal mesh devices fall under?
And that’s how a "moderate risk" medical device (which of course turned out to be anything but) was approved. And we all know what happened next: moderate-risk turned into erosion, severe pain, the need for multiple revision surgeries and more.
Now what? The civil justice system is the way to fight back.
Click here to contact Baron & Budd for a free and confidential consultation or call us at 1.866.472.9108 to see if you or a loved one can take part in the transvaginal mesh lawsuit.
To read the 2011 FDA report click here: http://www.fda.gov/downloads/medicaldevices/safety/alertsandnotices/UCM262760.pdf