Confidential: pharmacokinetics information gel filled mammary protheses

The urine did't contain intact D4. Instead, D4 degradation products, including dimethylsilanediol, tetramethyl 1,3 disiloxanediol and hexamethyl 1,5, trisiloxanediol were detected which is suggestive of ring opening at the siloxane bond.(Dow Corning 1980)

1997: Formation of methylsilanetriol is indicatave for D4 ring opening and the occurence of some demythylation (oxidation and hydrolysis)

Exposure to D4 en D5 have been evaluated and related to the effects of phenobarbital.

In its conclusion the National Science Panel confirmed that the 'prepordonance of evidence from animal studies indicates little probility that silicone exposure induces or exacerbates systemic diseases in humans >>

Stoffen in oudere McGhan implantaten 1990 -2000


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McGhan Implants Ingredients from FDA ~ Chief of PS DevicesDate: Sunday, December 05, 1999 10:20 AMSubject: McGhan Implants

Ms. Pyron:

Your e-mail dated November 25 regarding McGhan Medical breast implants was forwarded to me. You had two inquiries: when your implants were manufactured and what are the material constituents. For the former, FDA does not have information on the date of manufacture of implants based on lot numbers. For this you can contact McGhan Medical in Santa Barbara,

CA, 1-800-624-4261. Regarding the materials, this style of implant has a silicone rubber shell and is filled with silicone gel. The silicone rubber contains the following substances:

1. small amounts (parts per million) of various smaller silicones

2. small amounts (50 - 100 parts per million) of metals like tin and platinum and very trace amounts of other metals

3. trace amounts of volatile materials like xylene and other organic compounds

4. considerable amounts (approximately 20 parts per hundred) of finely powdered silica that is tightly bound to silicone rubber pouch/

The filler material contains silicone oil and silicone gel in addition to the four materials (chemicals) listed above. I hope this answers your questions.


Stephen Rhodes

Chief, Plastic and Reconstructive Surgery Devices

PR plan for silicone breast implants

Het is een hele kluif om te lezen, maar geeft wel goed aan wat er allemaal mis was. Hier staan documenten in, die in het bezit van de FDA kwamen maar ook memo's van Baxter en Heyer Schulte.

Ook de naam van ene Carson wordt hier genoemd. Hij is later aangeklaagd voor fraude. (we weten niet of dit te maken had met >>

What causes asthma

Op 3/4 hoogte van de pagina gaat het over borstimplantaten, ook dezelfde recepten van McGhan.

Astma in patients with siliconen breast implants: report of a case series and identification of hexachloroplatinate contaminant as possible etiologic agent

Michael R Harbut Brenda C Churchill* IJOH; 1999; 3:73-82. University, School of Medicine, Detroit, Michigan, and *Department of Internal Medicine, Providence Hospital, Southfield, Michigan Address for correspondence: Michael R. Harbut MD , MPH; Wayne State University School of Medicine, Detroit, Michigan, and Center for Occupational and Environmental Medicine, 22255 Greenfield; Southfield, Mi. 48075


The following study is of 8 breast implant patients evaluated because of respiratory systems, pruritus and rhinorrhea. The presence of hexachoroplatinate in the implants was notes and support for the hypothesis that this contaminant was related to the symptoms experienced by the patients is presented. Cases of implant related asthma were defined by episodic dyspnea, cough, or breathlessness with onset or worsening after implant placement and objective evidence of reversible airways obstruction, either during the presence or after the removal of the devices. All eight patients were found to have asthma, with airway hyper-reactivity demonstrated by methacholine challenge testing performed in seven patients and by partially reversible obstruction after nebulized administration of a beta-agonist in one patient. Eight patients had urticaria and seven had rhinorrhea. Eight of eight breast implant patients evaluated had findings consistent with asthma. Hexachloroplatinate, a potent sensitizer and component of breast implants, is identified as the likely primary etiologic agent in view of findings consistent with platinosis in these patients, and the demonstration of the leaching of hexachloroplatinate from even intact silicone breast implants.

Baby mismaakt en overleden door McGhan siliconen

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Event Date 11/11/1995Event Type Death Patient Outcome Death, Diability, Other, Congenital AnomalyEvent Description

Rptr writes, "child born with birth defects. She was attached to my uterine walls. She had a short umbilical cord. She looked like silicone had fused to the lower half of her body - similar to burn scars. She had no genitals, rather just limbs with tissue on them. It looked as if the silicone got intertwined with the developing cells and developed in with her body. This created the stomach and liver to be on the outside of the body. The chest wall was messed up. The heart was covered with tissue, yet on the outside of the body cavity. The spine was curved backwards. She was glued to my uterine walls and had to be plied off of them upon delivery. It was as if silicone was in my uterus and she got caught up in the web as she started to develop. I suspected i had a ruptured implant during pregnancy, however, it did not occur to me that the silicone could have migrated and caused a problem. It did not occur to me that this could cause any birth defects because i had been told there was no way it would rupture, if it did it would just absorb into the body and be ok. I have pictures of her. She lived 45 minutes after birth."

Nóg een mismaakte baby, die slechts 9 maanden leefde. Moeder had lekkende McGhan implantaten gedurende de zwangerschap.

Child born with no spleen. Liver and stomach was in the middle of the body and liver was left side of body. Heart murmur, hole in heart, blue baby, esophageal hernia, colitis, stomach malformed, no holding tank, stomach was pulled up into esophagus. Transposition of the great arteries. Patent ductus arteriosis, "d-tga", pavrheterotaxy syndrome, pulmonary atresia, ventricular septal defect, anomolous pulmonary venous return to venous confluence at right superior vena cava/right atrium junction. Nonrestrictive atrial septal defect. Inferior vena cava and right superior vena cava to right atrium left superior vena cava to left atrium small bridging vein. Hepatic veins to both right atrium and left atrium descending transposition of the great arteries with subpulmonic stenosis. Gastritis, she had various lung problems and immune deficiency problems renal insufficiency, liver failure. Microgastric with midline stomach consistent with heterotaxia syndrome, malrotation and gastroesophageal reflux. Irregular area in the region of the gastroesophageal junction and ulceration, bilirubin. 6. 3, cholestasia. Gastrointestinal bleeds. Rptr had leaking silicone implants throughtout the entire pregnancy. Rptr believes the deformities were from the silicone. This child lived nine months.