While reading the "Breast Implant Horror" article in the November issue of Glamour magazine a startling realization emerged. Our FDA is in dire need of redefining their "Mission Statement".  

Speaking on the issue of allowing Breast Implants back on the market, Dr. David Feigal, FDA's director for the Center for Radiological Health, states "The whole purpose of the FDA approval process was to gather information so patients know exactly what to expect." 

For their part, the manufactures and plastic surgeons maintain the complications and risk associated with breast implants are such a small price to pay for the benefits of bigger breasts, all things consider. For our part, I can most definitely assure these people that the benefits we've paid have been anything but SMALL both emotionally and physically or financially. When we see any product stamped "FDA Approved", it is assumed by the American public the product has withstood the most ridge testing in the world and deemed safe. 

In 1992, then director of the FDA, Dr. David Kessler stated "If members of our society where empowered to make their own decisions about the entire range of products for which the FDA has responsibilities, then the whole rationale for the agency would cease to exist. People would simply communicate directly with manufactures to design their own drug regimens or select medical devices." 

It's time for the FDA to evauluate and redefine its mission as much more than an information gathering and dissemination office. I ask you Dr. Feigal to scrutinize the plaintiff's conclusion of the NSP report on Platinum below and tell me this is a small price to pay for allowing breast implants to stay on the market. We can only hope your reply is more promising than our doctors or this reports conclusion. 

Respectfully,

Robert Olexa  

Plaintiff Conclusion - NSP report on Platinum 

V. SUMMARY AND CONCLUSION 

The Parties agree that "platinum salts" (aka chloroplatinic acid) can cause systemic disease in humans as a result of toxic and/or hypersensitivity reactions. These toxic and hypersensitivity reactions can range from asthma, rhinorrhea, tinnitus, conjunctivitis, urticaria, fatigue syndromes secondary to impaired oxygen exchange, neurotoxicity, sicca syndrome, and macular rashes.  

The Plaintiffs' Submission proves that silicone gels and elastomers do contain unreduced chloroplatinic acid, i.e., "platinum salts." The Defendants' internal documents, the testimony of Defendants' employees, and the admissions of the Defendants in their Supplemental Submission on Platinum constitute such compelling proofs that a fairminded scientific review can reach only one conclusion. 

Plaintiffs Submission on Platinum also shows that, even if one buys the "scientific position" of Defendants, i.e., that all platinum salts are reduced to sub micron sized elemental particles in colloi dal suspension) in susceptible individuals, sub-micron sized elemental platinum, platinum in colloidal suspension, and platinum metal, can each be a toxin and/or a hypersensitizer in humans. 

Plaintiffs further establish, through the submission of Dr. Wabeke, that the amount of platinum in silicone gel elastomers and implants is not a "small amount" but rather, a tremendous amount i.e. , as much as "1000 x the permissible occupational exposure." 

Finally, based on the extensive peer reviewed research published on elastomer shunts we find a decades long track record of hypersensitivity disease, hypersensitivity complications, and elastomer shunt failures. Because silicone elastomers (e.g., shunts) have ten times as much platinum catalyst as silicone gels, the extensive rate of shunt toxicity arid hypersensitivity complications cannot surprise the Defendants. Why would we expect a different result from the gels and elastomers in breast implants? 

In conclus ion, specifically as to individual patients with individual signs and symptoms, and generally, as to the mechanisms of toxicity and hypersensitivity as outlined in this Submission, a compelling medical and scientific case is made that platinum salts, as a residual contaminant in silicone gels and elastomers are a probable factor, or co-factor, in a variety of the complaints and diseases presented by women exposed to silicone gels and elastomers. These facts compel a conclusion that, silicone gels and elastomers can cause systemic diseases in humans.