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July 29, 2011

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Stewart J. Lustgarten,
2426 Treasure Isle Drive
Palm Beach , FL 33410
&
73 Dalton Road
Holliston, MA 01746
561.371-4002
stewart@pharmexintl.com
Consultant To The Dental Industry
CLINICAL & CONSUMER PRODUCT DEVELOPMENT
TECHNOLOGY TRANSFER
REGULATORY AFFAIRS
MARKETING & DISTRIBUTION
IMPORT /EXPORT
Dear Dr. Challoner

I found very interesting the timely N.Y. Times/AP article relative to 510(k)'s and which mentions your name. My background includes going to Jai Alai in Ocala with the late Jose Medina and Bill Collett and I was very instrumental back when, in facilitating the teaching of sit down, four-handed dentistry in the clinics and pre-clinical labs of U of F and assisting faculty in curriculum development for the incoming freshman prior to the windowless school even been built.

As a member of the Board of Directors of the Dental Manufacturer's of America, I was chosen pre-1976 and post '76 as non-partisan liaison with FDA's Mr. David Link to express our dental industry medical device views on implementation and which David took me up on many of my suggestions. David then became the first Director of then FDA's BRH&MD.

I bring to your attention as a Grandfathered 510(k) product with very little scrutiny, "Methyl Methacrylate (MMA) Bone Cement" which is universally used to cement orthopaedic prosthetic knees and hips into place. Ironically, one hand of FDA doesn't know what the other hand is doing, for in 1976 the Bureau of Cosmetic's panel of dermatology deemed it a poison of which has been shown to cause harm to the human body. It then banned its topical use for false fingernails. Today however, it continues to be widely used for systemic use as bone cement.


“As early as the 1970’s the FDA expressed that MMA monomer is “a poisonous and deleterious substance and should not be used in liquid acrylic monomer for nail enhancement products” as it is an extremely high sensitizer and likely allergen that can cause severe allergic reactions through minor skin exposure. The FDA still holds strong on its stance for the safety of this product.” FDA
Bone Cement, of the variety I described, is available from many companies and is an off shoot of self-curing dental repair material, self-curing temporary Crown & Bridge Material and Custom Tray Material. Pre-1976 it was classified as a Class III drug with very little FDA scrutiny. It crossed over into the new FDA regime for Medical Devices as a Class III, PMA, but never were there any controls or standards ever promulgated. In early 2003, it was re-classified as a Class II and which FDA did then issue controls and now is where the rub comes in.

In June, 2005 my late wife had knee replacement here in Boston and soon after never felt right. She felt very weak with her nerves bothering her. In January, 2006 she was initially diagnosed with Vertigo but then on referral to a neurologist was diagnosed with para neo plastic syndrome (opsoclonus /myoclonus). This originally was found to be emanating from a newly formed small cell lung cancer lesion which was sectioned away. However, her deterioating PNPS condition inhibited the use of conventional chemotherapies to be used. (see attached). and which she succumbed to cancer the end of Aug. 2006, however her PNPS was terminal in itself.

Getting back to MMA Bone Cement, Bone Cement requires the external mixing of a safe soluble polymer of Poly Methyl methacrylate P(MMA) with a very lipid solvent and reactive un-safe monomer of liquid Methyl methacylate. (MMA) of which when they react is systemically placed in the human which then exothermically hardens in a matter of minutes to secure the implant firmly to the prepared bone. As many dental material text’s and others teach, the reduction/oxidation polymer reaction which takes place between the P(MMA) powder and (MMA) liquid has about 40% incomplete conversion, with harmful MMA vapors and liquid continuing to leach and volatile out and directly into one’s vascular system for up to 3-4 months. Very much like the current ” Bis-phenol A” problem.

MMA is on the proposed lists if immuno and neuro toxicants and has been shown by gov't agencies to be cytotoxic, genotoxic and a mutagent. This being the case, on the grandfathered products there has never been any longitudinal studies to determine final outcomes. A fairly large percentage of patients die right on the operating table from anaphylactic shock, those we know about. But what we don't know about are all those who die some years after as a result of the immuno and neuro-toxicants.? Studies have shown in Japan that only after 15 minutes of insertion, Non-specific Astraglial “B” protein and substantial amounts of MMA appears in the titre. Once MMA gets into the bloodstream, it hydrolysis to methacrylic acid and formaldehyde. (See, Skinner). Even bigger No No's!

Now that you know the background now comes the interesting part of it all.

In a recent and on-going lawsuit against one such manufacturer and since its in the public record, the out right lied to the Court as their product not being a Class II but rather a Class III and 510(k) exempt on several occasions. This although the official FDA records showed otherwise. Their object was to confuse the Court so they can win a Motion to dismiss of Preemption. Finally the Judge got so fed up she dismissed my case on a technicality. With the technicality cured, I brought the case again. Now my intent is to sue the lawyers who lied to the Fed. Dist. Court, Mass.

Now the industry wide scam!

At present, there are much more safer self-curing Bone Cements used in Europe which were offshoots of dental composite filling materials and do not contain the poisonous and highly volatile components. However these polymer resins are slightly more expensive then the MMA and P(MMA ) variety.

Five years ago and at wholesale costs, I could have purchased from Esstek Inc, Essington, PA, 1-lb. ea (454 gm) of either ready made MMA liquid or P(MMA) powder for about $6.50/lb. It is then packaged in individual unit doses of 75 g (P&L) for hundreds of dollars each. Considering a lb. Yields about 6 unit doses we're talking thousands in gross profits. This is not a matter that the derived healthcare benefits outweigh the risks for these newer and safer products are now being kept off the market to protect huge profits..

Now comes what I strongly feel is collusion between the industry and FDA. Knowing that newer and safer Bone Cement products were being developed in Europe, the industry realized the as a grandfathered Class III with no PMA required, it would best serve them to be re-classified as 510(k) Class II with standards and controls now promulgated and which the newer variety would probably pass but which required long term longitudinal studies and other and would keep them off the market here for sometime. And in many cases not warrant the expense. These controls were so rigid, not one of the old variety themselves could pass, but remember they were grandfathered to these rigid controls as well.

Unfortunately, Orthopaedist's never took dental materials in Med. School. All dentists do! In a recent phone call to Wayne Wozniak, Ph.D, Secretary of the ADA Councils of Dental Materials and Therapeutics he laughed when I told him that they use self curing custom tray material as bone cement. I received a similar response from Dr. D. Greg Singleton, the first director of the Dental Section of FDA's BRH&MD. I now leave it to you to ask your own dentist of the efficacy of it all. 'Nough said. However, in a recent phone call to the current FDA Dental Section Director and which she agreed with me, she then was scared of her shadow to walk next door to the Orthopaedics Section to convey this to their Director.

Soon after Dr. Margaret Hamburg assumed her position at FDA, I wrote to her essentially the same as I'm now writing you. Prior to FDA, she was on the Board of Henry Schein Inc. to which I once consulted to and Stan Bergman, Chmn .of the Board there, suggested I write her and using his name. My courtesy response came from an individual who still hadn't mastered the English language.

Sincerely,

Stewart J. Lustgarten

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