Letter from Dr. Kesssler - 1991

[Guest guest]

FDA1203/081193/41/54531

THE JOHNS HOPKIN'S HOSPITAL

600 North Wolfe Street

Baltimore, land 22205

December 12, 1991

Dr. 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 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 '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 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

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 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 to Hinsch: " Mammary Prostheses

Ruptures: " December, 1977

11. Memo from to Hinsch: " Report of Excessive

Ruptures and Loss of Business; " March, 1978.

12. Memo by s to Hinsch: " Physical Properties

Versus Time for Silastic II and Standard Prostheses: "

November, 1981.

13. Handwritten Analysis/Report by s: " 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 : " 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 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. Wiener and Dr.

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.

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 land. " I

sincerely hope this is simply another corporate

misstatement, since I helped write the land

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. , M.D.

Associate Professor, Medicine & Surgery

Enclosures

cc: Carol Scheman

Ruth Markatz

NDA/mja

FDA000054534