“The occupational medicine literature is emphatic in it’s opinion that at no stage should a worker be exposed to any liquid or solid containing any platinum salt.”
--Dr. Michael Harbut



“It’s a heavy metal. And like lead, mercury or gold, it is a very potent poison. It’s very difficult for the human body to rid itself of it when it is exposed to it. And it has been well known to be a sensitizer. It’s a lung toxic agent. Once it’s found its place in the lung, it causes allergic reactions. We’re finding platinum everywhere.”
– Dr. Ernest Lykissa



What does the FDA say about Platinum? Read the FDA Backgrounder on Platinum in Silicone Breast Implants
  A DEBATE AMONG SCIENTISTS: The State of Platinum

 

During the last ten years, a handful of scientists have published research regarding the presence of platinum in silicone breast implants. These scientists believe that platinum salt, a toxic form of platinum, may enter the body through breast implants and cause serious illness.

Like every other aspect of the breast implant safety debate, this theory is not free of controversy and has fierce opponents. In fact, both the IOM (Institute of Medicine) and the Food and Drug Administration (FDA) have concluded that platinum studies are inconclusive and flawed, with the FDA stating :

“FDA scientists reviewed the available studies from the medical literature on platinum and breast implants and did not find evidence that platinum present in silicone gel breast implants causes illness in women with breast implants.”

Both sides of the debate acknowledge that platinum, along with some other heavy metals, is used in the production of silicone gel and saline breast implants. Platinum is used as a catalyst to make silicone into the gel-like substance in silicone gel-filled breast implants. Platinum is also used to make the silicone shells of both silicone and saline breast implants. According to the FDA, the IOM, and manufacturers, the platinum used in the making of breast implants is in an inactive, harmless form.

However, several scientists believe that a toxic form of platinum—hexachloroplatinate, a platinum salt—may exist in breast implants in the bodies of some women and that this form is very dangerous.

In ABSOLUTELY SAFE, we meet Dr. Ernest Lykissa and Dr. Michael Harbut, two well known doctors studying women who believe they are sick from their breast implants. Both Dr. Lykissa and Dr. Harbut believe that some of their patients with breast implants are ill because of toxic exposure to platinum salt.

According to Dr. Harbut, even the smallest amount of platinum salt is toxic and may cause allergic reaction leading to serious illnesses, such as auto-immune disorders and respiratory problems—illnesses that many of his breast implant patients suffer from.

In ABSOLUTELY SAFE, Dr. Lykissa explains his research on failed implants and discusses the general presence of platinum in implants and the women he studies. Dr. Lykissa’s research is noteworthy because he studies “failed implants,” and the blood and urine of ill women with these breast implants. Dr. Lykissa’s research contends that not only platinum, but also a toxic platinum salt (platinum which is in a charged form, oxidized state) were found in blood and urine samples of women with breast implants.

These findings were sharply criticized by the IOM, the FDA, and other chemists. The FDA stated that the results of Dr. Lykissa’s 1997 study on platinum leakage did not “provide an accurate indication of the leakage rate in women with breast implants” because the studies’ methodology for measurement was flawed.

Along with the FDA, chemists (including those working for implant manufactuerers) criticized another study because it offered ideas about the state of platinum (in a charged, oxidized state) that were different than current understandings of platinum chemistry. The FDA called the findings about charged, toxic forms of platinum found in blood, urine, and brain tissue samples “unconfirmed” and labeled the study “of limited value.”

In ABSOLUTLEY SAFE, Dr. Michael Harbut, one of the most well-respected occupational health physicians working in his field, maintains that any platinum salt exposure is dangerous.
It is worth noting that during the FDA’s investigation of platinum and breast implants, the FDA did not investigate existing occupational studies. In fact, Dr. Harbut sent the FDA several individual study case reports regarding adverse effects of the devices and none of these were referenced in the FDA’s report. When asked about this, Dr. Harbut said “They have excluded an enormous body of already accumulated knowledge regarding the chemicals contained in these devices. They are either bad scientists or bad people.”

Read Dr. Harbut’s petition to the FDA about platinum salt and breast implants.

 

During the film, we meet Dr. Joy Taylor, one of Dr. Harbut’s patients who is suffering from respiratory disease. Dr. Harbut explains that Dr. Taylor’s illness is caused by severe allergic reaction to the silicone and/or components of the silicone in her ruptured silicone implants. Once a healthy, vibrant, and active woman, Dr. Taylor has suffered from pleurisy and other respiratory ailments.

The FDA has concluded that platinum in breast implants does not pose a toxic risk to women. In the FDA Backgrounder on Platinum in Silicone Breast Implants the FDA states:

“the platinum contained in breast implants is in the zero oxidation state, which would pose the lowest risk, and thus that the small amounts of platinum that leek through the shell do not represent a significant risk to women with silicone breast implants.”

Despite the FDA’s conclusions, the controversy about platinum in breast implants and possible platinum salt toxicity connected to breast implants continues. Many women, such as Dr. Joy Taylor in ABSOLUTLEY SAFE, believe that amidst the heated debate among scientists, manufacturers, the IOM, and the FDA, rests a chemical reason for their “unexplained and mysterious” illnesses.