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Silicone implant study "flawed," journal says

Article-Silicone implant study "flawed," journal says

National report — A study published earlier this year that reported elevated levels of platinum in some women with silicone breast implants is now being questioned by the editors of that peer-reviewed journal.

In the current issue of Analytical Chemistry, Catherine C. Fenselau, Ph.D., associate editor, states, "In hindsight, there now seem to be strong arguments that the science in the paper was probably flawed."

Study standards questioned

In particular, critics questioned the assignment of the platinum oxidation states in the study and the lack of analytical standards.

One critic observed, "It is not clear whether the oxidized forms of platinum were formed by the sample preparation procedure ... or whether they existed in the biological samples."

Also noted was that platinum levels in women with silicone implants were not found to be significantly different than levels in women with no exposure.

Principal investigators Ernest Lykissa, Ph.D., and Susan Maharaj, Ph.D., stand behind their study in which they reported that platinum levels in the hair, urine, nails and breast milk of implant patients with no previous platinum exposure were significantly higher than in women from the regular population.

Investigators cite funding

Dr. Maharaj acknowledges statements questioning the limited number of samples and controls in the study.

"As this is a very important issue in women's health, much more funding is needed to support a study by independent researchers that includes many more exposed women and an equal number of control subjects," she says.

Silicone implants have not been approved by the Food and Drug Administration (FDA) for use in the United States since 1992, when studies raised questions regarding their safety. Manufacturers Allergan and Mentor have applied for permission to begin marketing silicone breast implants.

Some experts believe that, despite the questions surrounding the study, the FDA will still choose to consider the Lykissa/Maharaj findings in greater detail before issuing their decision.

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