COULD FLAWED REGULATORY PROCESSES BE CAUSING A HIGHER INCIDENCE OF BREAST IMPLANT ASSOCIATED ANAPLASTIC LARGE CELL LYMPHOMA (BIA-ALCL) IN AUSTRALIA?

1. The Therapeutic Goods Administration (TGA) approved silicone breast implantation for women in Australia during 12 of the 14 years they were banned in the USA.

2. In 2007, in the USA, I was diagnosed suffering the biological effects of exposure to platinum salts, (most likely hexachloroplatinate), used in the gel/shell of my McGhan Style 410 BioDIMENSIONALTM Textured Surface Silicone Cohesive Gel-Filled Mammary Implants with INTRASHIELTM barrier shell placed in 2003.

3. Platinum salts were recognised as a cause of allergic sensitization in the late 19th and early 20th centuries. Hexachloroplatinate (aka hexachloroplatinic acid/chloroplatinic acid) is the most allergenic of all platinum salts.

4. The Occupational Medicine literature is emphatic that no one should come into contact with platinum salts, that there is no safe limit for exposure to platinum salts, and that any amount of platinum salt exposure is too much.

5. Between 10-20% of exposed individuals suffer its acute allergies.

6. Computation of the amounts of platinum salts present in two 250 cc silicone gel implants demonstrate an in vivo platinum salts exposure to platinum in women with silicone gel implants of an amount 1000 x greater than the occupationally allowed limit.

7. Allergan (formerly known as McGhan, then Inamed) textured implants account for the highest percentage of cases of BIA-ALCL in Australia and New Zealand.

8. Extremely small amounts of hexachloroplatinate are known to trigger immunologic reactions, cause asthma and damage brain cells, in addition to other health effects which have been reported in the medical literature.

9. Hexachloroplatinate is known to initiate an allergic inflammatory response. The consequence of long-term exposure to hexachloroplatinate is the development of very severe chronic allergic inflammation.

10. The association between chronic allergic inflammation and cancer has been widely reported.

11. Under certain conditions, very severe chronic inflammation triggers the establishment of a malignancy. Some cancers may lie dormant for years following seemingly curative treatment, and then strike back.

12. Platinum levels in blood/serum are not nearly as significant as the lymphocyte proliferation response to platinum salts which is known to potentiate and/or promote neoplastic risk in an environment rich in inflammatory cells.

13. The TGA recently provided me with confirmation that the platinum catalyst in my McGhan (Inamed/Allergan) implants was manufactured from hexachloroplatinic acid.

14. Already I had uncovered the fact that McGhan (Inamed/Allergan) had not only changed its gel type from that originally submitted in their pre-market application but, without TGA approval, the manufacturer also changed both its gel/shell ‘recipe’, with the addition of even greater amounts of platinum/platinum catalyst for a thicker gel/firmer shell for their 410FM range of silicone implants.

15. The more platinum salt added, the thicker the gel, the firmer the shell, the more severe the allergic inflammatory response, the greater the neoplastic risk, the likely higher incidence of BIA-ALCL.

16. Is it that the actions/flawed approval processes of the TGA, the regulatory body charged with protecting the health of silicone breast implant recipients in Australia, likely put them at grave risk of developing BIA-ALCL?
This iatrogenic disease is 100% preventable.

17. Double-blind specialist-dermatologist skin patch testing using hexachloroplatinate, tetrachloroplatinate, and samples of both the gel and the shell from the McGhan (Inamed/Allergan) implants removed from my body in
2006 triggered a systemic anaphylaxis.

18. Currently, I am being successfully treated with the only immunosuppressant drug that works to block the
inflammatory response induced by platinum salts.

19. The head of the BIA-ALCL research team in Australia has identified chronic infection around textured breast
implants as a possible cause of BIA-ALCL. As a prominent plastic surgeon, with his research generously
funded by Allergan, Professor Anand Deva’s conflict of interest is keenly on show.

20. The McGhan (Inamed/Allergan) products originally submitted for TGA approval were not eligible to claim equivalence for any aspects of their materials, manufacture, safety or efficacy, as no silicone gel implants had
previously been evaluated for inclusion or registered in the Australian Register of Therapeutic Goods (ARTG). This information is the culmination of more than a decade of meticulous research into silicone breast implants.
It has been sourced from scientific and medical literature, medical/operative/pathology/toxicology/radiology reports, court documents, material provided through Freedom of Information by Australia’s regulatory authority, the Therapeutic Goods Administration, and from my own personal experience.

Acknowledgment:
Professor Michael Harbut, MD, MPH, FCCP
Diplomate, American Board of Preventative Medicine, Occupational Medicine Clinical Professor, Internal Medicine, Wayne State University
Clinical Professor, Medicine, Michigan State University
College of Human Medicine

Dickenson, Dr. Helena, Regulatory Concepts Pty Ltd
Appendix, The Boobie Trap, (2015), P. 315.

https://www.theboobietrap.com