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There is some erroneous information put together by John Langone on 8/22/96. He states under Pt (or Sn) in Breast Implants:
Hexachloroplatinate/hexachloroplatinic acid used as a catalyst in munufacture of silicone breast implants (?)
-McGhan until 1987 (now Sn salts; Harbut) THE FDA STATES MCGHAN USES PLATINUM IN THEIR CURRENT GEL-FILLED IMPLANTS.
-D-C (DOW CORNING): NEVER used (Pt-vinyl siloxane complex; Burns) COURT STAMPED DOCUMENTS INDICATES CHLOROPLATINIC ACID WAS USED
THE FDA TOOK NO ACTION
Marlene
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Date: Mon, 7 May 2001 20:53:02 Sender: occ-env-med-l-admin@mc.duke.edu
From: M1har@aol.com Subject: Re: [OEM] Incidence and mortality risk studies among
U.S. breast implant pati...--part1_54.141fa35a.28289c7e_boundary Content-Type: text/plain; charset="US-ASCII" Content-Transfer-Encoding: 7bit
I appreciate Dr. Goldsmith posting these findings. We have seen a number of implant patients on referral after some of our local rheumatologists weren't convinced of connective tissue disease in these patients, and a toxicology/occ.med. point of view was desired. I've also seen (literally) thousands of patients employed at either Dow or Dow Corning, both of which are involved in this issue, either through manufacturing or other ways.
Brinton's brain cancer findings are consistent with our notification of the FDA of abnormal brain SPECT and PET abnomalities among women with silicone breast implants in l996. Interestingly enough, in 2 women we were able to study, we documented the PET's return to normal after the removal of the implanted devices.
We notified them of the presence of platinic acid in the devices and it's ability to pass the blood-brain barrier and poison mitochondria, as had ben previously reported.
The pulmonary findings are also consistent with our reporting to the FDA the findings of pulmonary disease ranging from asthma to COPD to fibrosis in this patient population. We informed the FDA (before our publication in the Israel Journal of Occupational Health) that the obstructive disease in these patients often required methacholine challenge to find, and that they needed to act. I think they did lunch instead.
We also did neuropsych testing and found significant abnormalities, and also notified the FDA. They did the same thing with them that they did with the brain and lung findings.
NIOSH's Dr. Ray Biagini, author of the WHO Platinum "sourcebook" (and easily one of the world's top toxicologists), and I both independently notified the FDA in l993 and l994 that there was a very real problem in the eventuality the ionic platinum used in the manufacture of these devices as a catalyst would make it's way out of the matrix of the devices (as catalysts are inclined to do). CDC's Henderson and (formerly) Baylor's Lykissa both showed a leeching of Pt, and Lykissa has speciated it to proove ionic forms.
As a final note, the symptoms discussed by Dr. Brinton are listed in the Institute of Medicine report on SBI's, and were as well reported by us to the world literature in 1999, so I imagine this will necessitate a letter to the editor in correction.
This Breast Implant story, is I think, only really beginning to overcome the PR of the attorneys (both sides) and the manufacurers.
Michael R. Harbut, MD, MPH Center for Occ/Env Medicine Roayal Oak, Mi
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More Platinum Found in Women With Implants
By DIEDTRA HENDERSON
The Associated Press
Updated: 9:03 a.m. ET Aug. 26, 2004
WASHINGTON - Researchers have found high concentrations of platinum in women who got silicone breast implants and in the children they bore and breast-fed afterward.
The type of platinum found in the women's blood and urine was different than the traces of regular platinum not uncommon in people's bodies. It was a highly reactive platinum, used to help turn silicon oil into the honey-like gel that lends a more natural feel to a breast implant.
Concentrations were up to three times higher than in women who didn't have breast implants, according to findings by S.V.M. Maharaj, a chemist at American University. Maharaj was scheduled present the findings Thursday to the American Chemical Society in Philadelphia.
Ernest Lykissa, a forensic and clinical toxicologist who co-authored the paper, said the study's sample size was small. But Lykissa said it fairly represented hundreds of women with implants he's studied over the years.
Women who had implants the longest recorded the highest platinum concentrations. The heavy metal was also found in bone marrow, where blood cells are made.
Distinct from platinum released by catalytic converters in cars, platinum in implants is treated with nitric and hydrochloric acids and becomes very reactive, Lykissa said. The heavy metal readily binds in the human body, especially to nerve endings, short-circuiting communication with the brain.
"You see green, but you perceive a full moon," he said. "All of a sudden, your brain system is not working right."
Some women developed nervous tics, had faulty perception, and impaired hearing and eyesight, he said.
Children born to women with implants had problems with eyesight and hearing, too, but those nervous system disorders may have been caused by something else, he cautioned.
The Food and Drug Administration in January stunned plastic surgeons when, contradicting the advice of its expert panel, it rejected Inamed's bid to reintroduce silicone breast implants. After safety concerns rose, the FDA banned such implants in 1992 for most patients.
In January, the drug regulatory agency asked Inamed for more details about what happens when silicone seeps from the implant.
Dan Cohen, a spokesman for Santa Barbara, Calif.-based Inamed, said the company would speak in detail about its formal reply, submitted to the FDA earlier this month.
But at the FDA's October 2003 advisory board meeting, the company briefly discussed platinum dispersion and concentration in implant patients. The company has tracked those patients for three years.
"It was not an issue that anyone dwelled on _ either our presentation or the panel," Cohen said.
For its part, the FDA in 2002 surveyed scientific literature that indicated platinum leaks from implants into surrounding breast tissue. Researchers said they didn't find anything suggesting women had allergic responses to leached platinum.
Paul H. Wooley, director of research for orthopedic surgery at Wayne State University, said it's been suspected for at least a decade that heavy metals used in manufacturing might cause problems for women who receive implants.
"I'm not sure these questions have been answered because, in general, they haven't been asked," Wooley said. "For political reasons, working on breast-implant patients has been somewhat difficult to do."
