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Summary

As a chemist specializing in the study of silicone, I often get questions from both medical professionals and women about the safety of platinum in silicone gel-filled breast implants. A small amount of platinum is used in the process of making the silicone elastomer (a rubber-like elastic material) for the outside covering (or shell) of the implant. Platinum is also used in the process of making the gel material that fills a silicone gel-filled breast implant and contributes to the cohesiveness, or firmness, of the inner gel in the implant. An average implant (about 400 mL) contains less than 4 mg of platinum (about one tenth the size of a drop of water).

Platinum is a natural metal that is all around us in our everyday lives – we are exposed to it by eating and breathing, through contact with certain kinds of jewelry and dental crowns, and various other sources. In addition, it has been used in medical devices for many years because it has a reputation for being quite stable in the human body. The type of platinum found in silicone gel-filled breast implants in very small quantities is metallic platinum, similar to that found in approved medical devices, rather than the form of platinum that is more active in the body, or platinum salts. Many regulatory agencies, including the FDA, have concluded that "there are no clinical consequences of the platinum in silicone breast implants" based on extensive literature studies.1

Background on the Role of Platinum in Silicone Gel-Filled Breast Implants

Along with my research group at McMaster University in Canada, I have conducted research on silicones and platinum for many years and published more than 100 papers on these subjects. Some of our research was directly related to the processes used in making silicone gel-filled breast implants, including processes that use platinum and other substances to create silicone elastomer. I have also worked for more than 10 years with manufacturers and regulators, such as Health Canada, to provide information related to various aspects of the silicone itself, as well as the methods for making and testing it.

While platinum has many forms, the key types are platinum metal and platinum salts. Platinum metal is very stable and has been used for many years in a variety of medical devices, including pacemakers and vagus nerve stimulators (for epilepsy patients). Platinum salts, on the other hand, are known to be active in the body. For example, they can lead to the development of allergic-based reactions such as dermatitis, asthma, etc., but they are also used as drugs for some diseases.

After a silicone gel-filled breast implant is made, very small amounts of platinum remain in the implant. A tiny fraction of this material can escape from the implant, along with silicone oil, in a process known as "gel bleed". Thus, it was important to establish the form of the platinum that was introduced to the body through silicone gel-filled breast implants and to evaluate potential health effects.

Read expert content on gel bleed

The experimental data in the literature on this topic are very consistent. The processes that turn silicone into elastomers also convert the platinum that is used into tiny particles of metallic platinum (that is, not platinum salts). I wrote a review about this question in 2006, which concluded that the form of platinum in breast implants is metallic platinum and that there do not appear to be any clinical consequences resulting from the presence of the platinum in the implant.2

A paper published in 2006 in Analytical Chemistry suggested the forms of platinum present in silicone gel-filled breast implants were bioactive platinum salts. However, the editor of the journal later indicated that the data could only be considered credible after further independent confirmation, because the experimental protocol that was used, "falls short of this journal's standards. Thus, we editors urge that our readers use caution in evaluating the conclusions drawn in the paper."3

So, Should I Worry About Platinum?

To put this question in context, it is important to remember that we are exposed to platinum every day – through breathing, eating, and direct contact with certain kinds of jewelry. Platinum is also found in dental crowns and other implanted devices. Women with silicone gel-filled breast implants will additionally be exposed to extremely small quantities of platinum from their implants. There currently does not seem to be a clear association between environmental platinum and disease states in the general population nor any clinical consequences for women additionally exposed to the very small amounts of platinum in breast implants.

There are several authoritative and unbiased review studies that have evaluated thousands of reports considering all aspects of the chemistry of breast implants, including the platinum used to make silicone shells and gel. These include the Institute of Medicine report (IOM) published in 1999. This report summarized the chemistry and toxicology of platinum and breast implants, based on a number of studies published up to 1999.1 Based on studies available to that date, the IOM concluded that, "evidence does not suggest there are high concentrations [of platinum] in implants, significant diffusion of platinum out of implants, or platinum toxicity in humans."4 They also concluded that platinum in implants was not in the form of salts.

The FDA, as part of their recent, extensive and rigorous evaluation of all of the available literature, considered platinum and issued a special summary on the topic before re-approving implants in 2006 for use in the United States.1 They concluded that the type of platinum found in breast implants, based on the wealth of existing data, was a very stable form that did not pose health risks for women. They noted that "the experimental evidence supports the conclusion that there are no clinical consequences of the platinum in silicone breast implants."

Silicone gel-filled breast implants represent one of the most extensively studied FDA approved medical devices in existence, with hundreds of peer-reviewed and published reports on studies supporting their safe use. While continued research is always warranted with medical devices to look for very long term effects, currently there is no scientifically credible evidence linking the metallic platinum in silicone gel-filled breast implants to health concerns.

Q.

Why can’t you make the implant shell without platinum?

A.

There are other ways to make silicone elastomer, but the big advantage with platinum is that very little is needed. An average implant (about 400 mL) would contain less than 4 mg of platinum (about one tenth the size of a drop of water).

Q.

Where else would I be exposed to platinum?

A.

Platinum is an incredibly useful metal that speeds up many different kinds of reactions. One of its main uses is in automobile catalytic converters, to clean up car exhaust. As a result, platinum is found particularly alongside roads and we all inhale and eat small amounts of platinum particles. It is also found in many everyday items like dental crowns, jewelry and wire.

Q.

What kind of platinum is found in silicone gel-filled breast implants?

A.

The platinum in silicone gel-filled breast implants is found as very, very small metal particles (one thousandth or less the thickness of a human hair). The biologically active platinum salts that are of greater concern have NOT been found in silicone gel-filled breast implants.

Q.

I read in the newspaper that platinum salts were found in silicone gel-filled breast implants?

A.

There was a paper in the very good journal Analytical Chemistry saying platinum salts were present in silicone gel-filled breast implants. However, after receiving several letters to the editor from other scientists, the editors re-examined the original information and concluded that the data was of poor quality, that the paper should probably not have been accepted in the first place, and that the conclusions should not be considered valid.

Q.

Will the platinum in silicone breast implants make me sick?

A.

Platinum salts are quite active biologically. This can be both good and bad. Workers in the platinum industry exposed to platinum salts can have strong allergic reactions to them. On the other hand, platinum salts are among the best drugs for treating cancers, such as ovarian cancer and testicular cancer. These forms of platinum, platinum salts, have not been found in silicone gel-filled breast implants.

The historical experience with platinum metal in breast implants has been very good. As a result, many medical devices that contain platinum metal are approved by the FDA.

Extensive studies have looked at the possibility that the platinum in breast implants is harmful. The FDA considered this point in great detail, and before re-approving silicone gel-filled breast implants, agreed with the comment I made in a review article of platinum in breast implants that, “The experimental evidence supports the conclusion that there are no clinical consequences of the platinum in silicone breast implants.”

Q.

So, can everyone forget about the platinum in silicone gel-filled breast implants?

A.

Silicone gel-filled breast implants are among the most extensively studied FDA approved medical devices and their 2006 “re-approval” by the FDA was based on an enormous amount of data demonstrating their safety. However, with any drug or medical device it is important to maintain vigilance. The only way to learn about situations that affect relatively small numbers of patients, or about long-term effects, is to continue following the health of patients over time. Manufacturers of breast implants are keeping track of changes in the health of their patients, and scientific studies are ongoing to ensure there is no correlation between the platinum in breast implants and women's health issues.

1 http://www.fda.gov/cdrh/breastimplants/platinum.html
2 Brook, MA "Platinum in Silicone Breast Implants." Biomaterials 2006; 27:3274-3286.
3 Brook, MA "Comments on Total Platinum Concentration and Platinum Oxidation States in Body Fluids, Tissue and Explants from Women Exposed to Silicone and Saline Breast Implants by IC-PCPMS." Analytical Chemistry 2006: 78: 5609-5611.
4 Bondurant S, Ernster V, Herdman R. "Safety of Silicone Breast Implants, Report of the Committee on the Safety of Silicone Breast Implants, Institute of Medicine." Washington, D.C.: National Academy Press, 1999.