A 510(k) is a premarket submission made to FDA to demonstrate that the device to be marketed is as safe and effective, that is, substantially equivalent, to a legally marketed device (section 513(i)(1)(A) FD&C Act). Submitters must compare their device to one or more similar legally marketed devices and make and support their substantial equivalence claims. A legally marketed device is a device that was legally marketed prior to May 28, 1976 (preamendments device), or a device which has been reclassified from Class III to Class II or I, a device which has been found SE through the 510(k) process, or a device that was granted marketing authorization via the De Novo classification process under section 513(f)(2) of the FD&C Act that is not exempt from premarket notification requirements. The legally marketed device(s) to which equivalence is drawn is commonly known as the "predicate." Although devices recently cleared under 510(k) are often selected as the predicate to which equivalence is claimed, any legally marketed device may be used as a predicate. Legally marketed also means that the predicate cannot be one that is in violation of the FD&C Act. 1

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We have not been able to find standards or regulations for training to be accrediting to implant a neurostimulator: DRG Dorsal Root Ganglion, PNS Peripheral Nerve Stimulator, SCS Sacral Nerve Stimulator.

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We interviewed a Sales Representative from each of the PNS manufacturers. All said that doctors are required to read the manual and attend a manufacturer's training session which is a speaker showing a video and/or PowerPoint-type presentation. They said some doctors practice on cadavers.

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We have asked two pain management doctor who implant neurostimulators, They confirmed it was true.

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We also asked if either would be willing to train to implant a PNS for pudendal neuralgia. Both said, "No." Even after talking about the fact that the pudendal nerve carries sensory and motor signals and controls the urinary and anal sphincters - and that an injury to this nerve it could cause permanent incontinence urinary and/or fecal incontinence, they both said "no" again. This means that 99% of pain management doctors have never implanted a PNS for pudendal neuralgia and if/when they ever do, the patient will be their first.

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Our experience with doctors in other specialties is that an inexperienced doctor trains with an experienced one before conducting the procedure on their own.

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We called the FDA about training standards for doctors implanting medical devices. The representative said those are handle by each state medical board.

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We called one state medical board. The representative said that there is no statue, law, or standard in writing. They also said that a board is made up of mostly doctors who earn a lot of money implanting medical devices. This is a clear conflict of interest that the doctors are regulating themselves.

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​In 2022, the global medical device industry was worth $492 billion, and is expected to reach $656 billion by 2032. North America accounts for 39% of the total medical technology market, and most of the world's top original MedTech equipment producers by revenue are based in the U.S.. Large medical device companies typically have profit margins of 20–30%.

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We are not doctors, but based on past human behavior, when there is this much money at stake, there much be independent oversight of an industry.

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NOTE: We've each contacted our elected state senator to look into this matter and see what can be done to change the status quo. It puts patients' safety at risk.  We will update as soon as we receive information.

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For, now, it is recommended ask your doctor their qualifications to implant a peripheral nerve stimulator for pudendal neuralgia. Then you must decide what is right for you. Travel may be necessary to find a doctor with the experience one would expect from any other specialty physician to have before performing a surgical procedure.

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Quotations from The Bleeding Edge 2018 documentary film

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"But the risk is so unbelievably high.  You brought up da Vinci. 2  I mean, these are these high-tech surgical robots, and everybody's probably seen a little video of them on the news somewhere along the way, but as these things were discovered and developed, all with good intentions and all for good reasons and can really help when operated properly, but they started being brought into any doctor’s office who could afford to bring it into, and these doctors are doing surgery on people without the proper training.  Let’s just listen to one doctor, Dr. Robert Poston.  Let’s just take a listen.

 

[Clip plays] Robert: I was told that it takes 10 cases to get good at robotics, but I know now in retrospect that I didn’t really start to feel comfortable until I was about 200 or 300 cases." 3

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1 https://www.fda.gov/medical-devices/premarket-submissions-selecting-and-preparing-correct-submission/premarket-notification-510k#se

2 da Vinci Robotic Surgical Systems https://www.intuitive.com/en-us/products-and-services/da-vinci

3 The Bleeding Edge 2018 ‧ Documentary film overview: "A look at the fast-growing medical device industry reveals how the rush to innovate can lead to devastating consequences for patients."

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Pudendal Neuralgia Alliance

contact@pudendalneuralgiaalliance.org

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