FDA1203/081193/41/54531
THE JOHNS HOPKIN'S HOSPITAL
600 North Wolfe Street
Baltimore, Maryland 22205
December 12, 1991
Dr. David Kessler
Commissioner, FDA
5700 Fishers Lane
Rockville, MD 20847
Dear Dr. Kessler:
I am writing as a member of the present General and Plastic Surgery Advisory Committee, and past chairman of that same panel during FDA reviews of breast implant usage in 1983 and 1988, to urge that all gel-filled silicone breast implants be promptly removed from the public marketplace and made available for continued use only under controls provided by investigational device exemption until further research provides reasonable assurances of their long term safety and efficiency.
This appeal is not made lightly. In past years, I have witnessed attempts by some breast implant proponents to suborn governmental, regulation by: editing their research data, selectively reporting device-related complaints, discrediting their scientific critics, demeaning patients with adverse outcomes, and substituting political influence for their own faulty science. Many such activities were equally evident preceding and during the November panel meeting. Yet, at the time of closing it seemed entirely plausible that the responsible marketing practices promised by the manufacturers under the glare of public scrutiny might suffice to protect consumer interests until all scientific uncertainties over the gel-filled implants were resolved under time tables to be established by the FDA.
Regrettably, those hopes for ending public ignorance on the long term sequelae of breast implants have been extinguished by corporate maneuvering. Although Dow Corning Wright has openly stated that it fully disclosed all relevant information to support the PMA applications reviewed by the advisory panel in November, I am now in possession of unprotected court documents which indicate this was not done. That overt breach of the public trust is exemplified by remembering that in the panel meeting I repeatedly asked Dr. LaVier for data on the incidence of implant rupture, any evidence for biodegradation of retrieved implants and explanations for Dow Corning Wright's "limited warranties." His response was to state that such information did not exist and that he was insulted by my questions.
Attachments to this letter from the case of Cardinal v. Dow Coming in the Michigan Court of Appeals #138959 establish that, in fact, Dow Coming Wright possessed such information and has used it to direct business practices since 1970. The following listing of office memos from the business records of Dow Corning Wright leaves little doubt of their misrepresentation of the facts:
1. Memo from Koning to Mantle: "Increasing incidence of Ruptures"; June,1970
2. Memo from Caterer to Woodward: "Dr. Bader--Ruptures'; January 197l.
3. Memo by Koning: "Envelope Degradation"; January, 1971
4. Memo by Koning: "Envelope Degradation"; February, 1971
5. Memo from Morgan to Koning: "Envelope Degradation;" March, 1971.
6. Memo by Koning: "Mammary Return;" March, 1971.
7. Memo by Koning: "Extravasation;" April, 1971.
8. Memo by Koning: "Rupture;" May, 1972.
9. Memo by Rathjen to Baecker: "Request for Information on Breakage Rate of Silastic round Prostheses:" April, 1973
10. Memo from Lewis to Hinsch: "Mammary Prostheses Ruptures:" December, 1977
11. Memo from Lewis to Hinsch: "Report of Excessive Ruptures and Loss of Business;" March, 1978.
12. Memo by Peters to Hinsch: "Physical Properties Versus Time for Silastic II and Standard Prostheses:" November, 1981.
13. Handwritten Analysis/Report by Peters: "Returned Mammaries made in 1975;" May 1976; May, 1982.
14. Memo from Jakubczak to Matherly: "Silastic II Mammaries--Loose Gel HH023099 (Drums, 1,2);" April, 1983.
15. Memo by Frisch to Dumas: "Returned Breast Implants." February, 1984.
16. Paper by Gerow, et al: "The Biodegradability of Organo-Silicone: Clinical Management Implications."
17. Letter from Dr. Mobley to Hayes: "Termination of Relationship with Dow Corning due to Ruptures;' October, 1985.
In light of these disclosures, I must urge that FDA initiate a full investigation and immediate review of all Dow Corning Wright business and scientific records alluded to in the above Court proceedings. At the very least, this compilation of citations suggests that a series of implants marketed between the mid-1970's through the mid-1980's pose potential hazards to their wearers that have never been conveyed to patients or physicians.
It is equally obvious that good faith actions by the FDA cannot be substituted for good science when vested interests run counter to the public need for resolving 30 years of controversy. I believe the FDA must now act firmly to restore scientific credibility to regulatory processes that are in danger of being molded by PAC's and political influence peddling. Justification for these concerns are illustrated in additional attachments accompanying this letter. However, they can be summarized here by noting that following the November panel meeting, the manufacturers and proponents of breast implants have reverted to skillfully devised programs of "spin management" which frequently equate with misleading pronouncements and unsubstantiated claims of device safety. Those practices may be routine business fare for influencing public opinion and mobilizing congressional support, but, they should never prevail in matters of consumer health.
More flagrant are actions billed as good public relations efforts which utilize media advertising to direct the health concerns of individual consumers into corporate telephone centers where neither the content nor the accuracy of the advice rendered by "trained staff" is scrutinized by the FDA. I have telephoned these centers seeking advice as a distraught husband whose wife is uncertain about breast reconstruction and received counsel given warmly but replete with glaring inaccuracies that clearly represent a corporate version of insidious deceit which can only he reconized by those who are quite knowledgeable about the implant controversy.
Dr. Kessler, I invite you and your staff to make similar assessments through your own telephone conversations with these "information centers." If you conclude, as I have, that they are designed to protect the product and not the consumer, then the time has come to place all silicone gel-filled implants in a mandatory IDE status. Any compromises short of that regulatory status will surely be countered by the "spin makers" who have voided every good faith previously extended by the FDA. I will also point out that such policies would be entirely consistent with your past demands for fair labeling practices in the food industry and with the actions you have taken against the "Misty Gold" breast prosthesis because of unsubstantiated claims, without your having to make any determinations of implant safety from the paucity of meaningful available data.
I must also express grave concerns that the process pursued by the FDA in the recent panel meeting inadvertently contributed to the disinformation that is now being used by "spin makers" to mold public opinion on breast implants. By designating an advisory panel of 11 voting members where only 4 had any semblance of familiarity with breast implants, the FDA created a body of novices susceptible to the one-sided testimony of experts selected by the manufacturers and the stature of professional societies advocating continued marketing of these devices. This strategy did work well in the panel's review of PMA data submitted by the four manufacturers because the corporate stances were effectively offset by excellent scientific appraisals from the FDA staff members who are to be commended for their fine work. But in the equally important task of defining a public health need for continued availability of these devices, the outcome was a shambles because there was scant balancing testimony from scientists who have studied the putative medical problems attributed to silicone implants and statements from Dr. Steven Wiener and Dr. Frank Vasey were not included in the proceedings. In such a tilted playing field, the opinions of psychologists and psychiatrists who have studied only the happier outcomes of breast implant usage easily carried the day for the manufacturers, while the testimony from 10 women clearly injured by failed implant surgery was dismissed as anecdotal irrelevance. Such edited deliberations by a body of experts who reviewed data restricted to the best devices currently available could only lead to flawed implications because they made no considerations for the possible hazards posed today for more than one million woman who are wearing vintage implants of antiquated shell designs, variable gel consistencies and uncertain gel formulations. To leave such questions unresolved would be an unpardonable omission by the FDA. Yet, these potential health risks were ignored unwittingly by the panel, the media and official FDA pronouncements which immediately began categorizing all such devices under the generic label of silicone breast implants.
Perhaps an even greater error came after the panel meeting in the FDA's Talk Paper issued on November 25. That publication states: "The panel chairperson, Dr. Elizabeth Connell of Emery University School of Medicine, emphasized that the group did not find evidence that implants are unsafe, but rather that there was not enough information about the risks and benefits of their use." While Dr. Connell may be quoted correctly here, I do not recall that I ever voted to express that precise opinion. In any event, the use of a double negative in the first phrase of that sentence has proven unfortunate for it is now being widely quoted out of concert as official FDA endorsement of breast implant safety. For example, in my recent telephone call to the Dow Coming Information Center, the counselor advised me that the "FDA found no evidence that breast implants aren't safe," and neglected to mention the qualifiers included in the second half of the sentence cited above. From that conversation, I can only conclude that the Talk Paper provided just the right grist for the needs of the "spin makers."
You should also know that in this conversation, the same Dow Corning counselor stated that continued marketing approval was assured by your pending January, 1992 decision. However, she did suggest that a "minor condition" would be attached "to ensure informed consent using a patient information pamphlet similar to that required by the law in Maryland." I sincerely hope this is simply another corporate misstatement, since I helped write the Maryland pamphlet and its use has done nothing to dispel lay worries about the long term safety of many, if not all, silicone gel-filled implants.
During the dozen years I have worked with the FDA, I have conversed with hundreds of women wearing breast implants. While hardly scientific, simple cataloguing of their statements reveals that approximately 90% of those experiencing implant rupture developed local, chest wall, upper arm and/or vague systemic symptoms that are reminiscent of the sequelae described after liquid silicone injections into the breast. Because the majority of these women received implants for reconstruction following simple or modified radical mastectomies, such outcomes may relate to the scant protection provided for the implants by the remaining local tissues--but with times to implant rupture typically ranging from 7 to 9 years, I fear that in vivo degradation of implant shell could be a contributing factor that would be relevant to all women wearing implants. To help resolve these issues, I am requesting your permission to work with the FDA scientific staff without compensation in reviewing case materials from the 4OO women who have reported device rupture to your agency over the past 2 years. Since the manufacturers have publicly stated that they do not test explanted devices, I again urge that you establish such a test facility and an appropriate registry for explanted breast prostheses within the FDA or by contract with reputable biomaterials testing firms. Nothing short of these actions can determine the health risks faced by women wearing implants of older design that were previously produced by existing manufacturers or companies that have gone our: of business.
In closing, I must apologize for burdening you with such a lengthy letter filled with requests. I do recognize the heavy burdens of responsibility you face in determining the future course of breast implant regulation in this country and trust that your decisions will be well reasoned and correct. Please recognize that I am at your service and would be privileged to meet with you to discuss any issues raised by this letter, if you so desire.
Sincerely yours
Norman D. Anderson, M.D.
Associate Professor, Medicine & Surgery
Enclosures
cc: Carol Scheman
Ruth Markatz
NDA/mja
FDA000054534