Myrl Jeffcoat myrlj@jps.net

24 mars, 2005 10:27

Dr. Henry Jenny's Fascinating Accounting of the Febraury 1992

FDA MEETING - FEBRUARY 1992

Early in November 1991, FDA commissioner David A. Kessler planned a meeting to announce that silicone gel-filled breast implants would remain on the market. Under normal conditions this would not have affected Dr. Norman Anderson, Professor of Internal Medicine at John Hopkins Medical Center and Chairman of the FDA's Plastic Surgery Advisory Panel. He believed that the silicone gel implants were safe for the public. As one of the nine voting members of the Panel, he had decided to vote in favor of the implants. A day or so before that announcement, however, Anderson came into possession of some documents implicating Dow Corning in fraudulent conduct regarding cover-up research which described the dangers of gel implants. Later on, Anderson discovered that these Dow Corning documents had been court-protected since the mid-1980's; that the FDA's legal branch had the opportunity to crack these court orders but, for their own reasons, chose not to do so.

Anderson wrote a letter to Kessler urging him to place an immediate moratorium on the implants. Kessler acted upon the letter, and on November 9, 1991, the FDA imposed a 90 day moratorium on all sales and manufacture f gel-filled implants. Without giving credit to Anderson, Kessler initiated the moratorium as if it were his own idea. In response to pressure from the manufacturers and plastic surgeons, Kessler called for an emergency three

day meeting to be held February 18-20, 1992 in Bethesda.

Three days before the hearing, Kessler phoned Anderson, told him he was biased, and removed Anderson's right to a vote. On the day before the hearing, Kessler said to Anderson, "It would be best if you resigned completely from the Advisory Panel." Anderson refused and it was at this point when he joined the side of the consumer.

I also personally experienced the FDA's modus operandi after having been invited to be one of the speakers at the hearing. It was the morning before the meeting while having breakfast at the Bethesda Marriott Hotel that I

received a call from the FDA's Executive Secretary, Paul Tilton. Tilton was in charge of the arrangements for the meeting, the one who determined who would speak and who would not. We had always had pleasant conversations by phone whenever I had spoken to him from my home in California. Now Tilton was on the phone saying "Dr. Jenny, I don't know how to break this to you but the manufacturers have put pressure on us and we cannot allow you to speak." Since I was taking this call from the breakfast lounge and in the presence of some of the others who were attending the hearing, I suggested that he call me back a few minutes later in my room in order to speak freely.

The call came and Tilton repeated his statement. I said, "Wait a minute. Are you telling me that the manufacturers put pressure on you, and you're yielding to them? You are a government branch, an agency to protect the consumer, in this case, the women. This is a public meeting, nothing private, no secrets!" Throughout my tirade, Tilton kept repeating, "Well, you know we can't change anything now and I'm sorry I was unable to reach you sooner." He had sent me a fax which I had not received since I had already left for the east coast. The fax read, "It's urgent, call me at home, do anything you can to reach me." I had only found out upon my return to California that Tilton was trying to tell me not to come to Washington, D.C. "Don't feel sorry, Tilton" I replied. "First of all, if you think that after having flown out here at my own expense and that after not having been allowed to speak after so many years, "I'm going to accept a gag order from the upper echelons of the manufacturers, you are wrong! Furthermore, if I'm not allowed to speak, I'm going to raise the biggest scene that the Fda has ever seen. If I do speak, what are you going to do, call the police and have me arrested? This is a public meeting and as far as I recall, we still live in a country of free speech. At least, that is what we have been

telling the rest of the world."

When Tilton finally understood that in no way would I restrain myself, he became concerned and suggested we try to handle this a bit differently. He then proposed that I remain in my room for another 20 minutes which would give him time to discuss it with others. "Sure," I responded. "As a matter of fact, I'll stay here in the room for one more hour and then I'm leaving with my wife for a visit to the White House and Georgetown." He agreed and seemed relieved. I waited the hour. Tilton never called me back.

Because of my personal involvement and knowledge, I was probably the one many feared the most. It had been 18 years since I had warned the FDA, manufacturers and plastic surgeons of the dangers of liquid silicone had silicone gel. None of the people attending the hearing had been involved for that length of time. After all many had assumed that I was living peacefully in Switzerland. Then suddenly I reappeared out of nowhere.

This is what I suspect happened behind the scene: The manufacturers; McGhan, Mentor, Bioplasty and Dow Corning, after having hated each other for so many years, were now forced to band together to save the silicone

gel-filled implant. Together they managed to convince Kessler and Tilton not to allow me to speak knowing that my testimony would be devastating.

The FDA was also on edge. They knew that if I were allowed to speak, I would publicly remind them about my repeated warnings to them between 1974 and 1981. I was the only plastic surgeon in the country who could say, "I told you so. I gave you paraffin tissue block containing the pseudo-capsule of a patient with an intact Dow Corning implant, and yet your experts failed to perform their own histology as they were supposed to do."

On the first day of the hearings, plastic surgeons and FDA scientists presented their work on various aspects of silicone implants. Much of this was not new.

One of the speakers was Boyd Burkhart, a plastic surgeon who described in glowing detail the benefits of gel-filled implants. When one of the women on the Panel asked him what type of breast implants he was using in his

practice, he had to admit that he only used saline-filled implants. It might have been of great interest to the public and the panel members to know that Burkhart had been deeply involved with Mentor. He even posed for a centerfold picture, dignified in a surgical mask, for Mentor's 1985 report to the stockholders. What is even more incredible is that he as a professional was conned by Conway, President of Mentor and Condon, Conway's go-for, into testifying at this hearing.

Dr. Stuart Nightingale of the FDA presented a paper on Japanese research with injected liquid silicone, an interesting retrospective study which for the most part, went over everyone's head. The few of us who understood the problem first hand were not allowed to ask a question, as no question/answer format was offered.

The FDA's Paula Wilkerson presented a positive assessment of the saline-filled implant, which I took as the best compliment the FDA could give me. It is unfortunate that Tilton and Kessler did not take the time to listen to some of their own people.

The next morning was filled with euphoric testimony by representatives of Dow Corning and Mentor, followed by those of McGhan and Bioplasty. They all expressed interest in conducting research which they had covered up in the past, claiming grave concern about the health of the women using their products. Every speaker promised to spend a fortune on future research, no matter what the cost.

Why hadn't they done diligent research back in 1978 after having heard my warnings? Well, the truth is they did do research but alas, they did not like what research was proving. So, they simply covered up the results.

In an indirect allusion to Dan Bolton's successful lawsuit against Dow Corning alleging fraud, the corporation's CEO, Keith McKennon, announced: "Dow Corning will not use the court orders to protect their material but will offer it to the FDA. If it becomes necessary to publish any of the protected material, Dow Corning will do so." Upon hearing this statement, Kessler seemed to be moved. He took the microphone and with emotion in his voice, expressed his gratitude to Dow Corning. This was truly a significant moment in the sense that it exposed Kessler's gullibility.

The evening session commenced at 7 o'clock on the second day of the FDA hearing. The moratorium was already in effect since the gel-filled implants were now reputed to be dangerous, even lethal, according to articles and the news on television.

The room was stale and the 500 plus crowd was tired, restless and ready to go home. Totally dominating the hearing so far had been the pro-implant speakers from manufacturing corporations, and plastic surgeons. Together they had applied their best efforts in trying to convince the FDA that the gel-filled breast implant should be allowed to remain on the market.

This last time slot had strategically been scheduled for the so-called "lesser" speakers. This group included Tom Talcott, a chemical engineer, Michael Resch, a mechanical engineer, Dan Bolton, a plaintiff attorney, Pierre Blais, a biochemist and me. While the pro-implant speakers had each been allotted thirty minutes to testify, we were limited to a mere ten minutes each. In addition to this, we were not allowed a question/answer period. This scheme, according to Norman Anderson, had been planned at the last moment by the FDA and the manufacturers. Everything was precisely arranged as in Kafka's The Trial.

The audience included the nine voting members of the FDA's General and Plastic Surgery Advisory Panel, the non-voting members, women personally affected by the gel-filled implants, women promoting the gel-filled implants, manufacturers, plastic surgeons, attorneys, major television networks, newspapers, radio stations, etc.

That evening several women spoke about problems with their breast implants. One of the speakers was Mrs. Janet Shrout, whose moving account of her daughter's death was described in "Criminal Negligence."

Soon it would be time for my ten minute speech. Yes, I was finally allowed to speak, but it was touch and go until four hours before my presentation. Luck had it that I was to speak just before Dan Bolton, known by everyone as the San Francisco attorney who had won the $7.3 million award for his breast implant client, Marianne Hopkins.

By now most of the women present had learned that I was Dr. Jenny, inventor of the saline-filled implant. Some of my adversaries were present. Don McGhan managed a strained smile. Some of the Mentor people looked seasick around me. As one would naturally avoid anyone with the plague, so was the attitude of several of the plastic surgeons towards me.

By the time it was my turn to speak, it was 8 o'clock, people attending were tired and many had already left to catch a plane home. The audience had shrunk.

Originally, I had prepared a very precise summary of my personal involvement in the breast implant affair. It was only after all the harassment and intimidation on behalf of the FDA and manufacturers that I felt compelled to change the tune of my testimony. I had been suppressed so long that my intact immune system had developed marvelous antibodies. So I decided to steady the tiller and navigate directly into the storm. It was truly exhilarating to finally be able to publicly blurt out the truth, noting every sing detail of their attempts to silence me. My testimony had to be concise since my time was very limited. Having to summarize my fifteen year involvement with implants in ten minutes was no easy feat. I briefly referred to my first meeting with Mr. Rudy Schulte and the creation of the first saline-filled breast implant in 1968. How the FDA had claimed to have "lost" my first paper in 1974, and had ignored the devastating histological evidence sent to them in 1978.

During my testimony, Paul Tilton was whispering something into the ear of Elizabeth Connell. I stopped in mid-phrase, fixed my glance on Tilton who continued to whisper totally oblivious to the fact that the room had become dead silent. After what seemed like several minutes, a doctor sitting to the right of Tilton, elbowed him to attention. Pointing my steady finger at him, I locked into his eyes and declared: "You Mr. Tilton, you are the very man who told me that the manufacturers had put pressure on everybody, and that I would not be allowed to speak. I am talking to you, Mr. Tilton. It was due to the same damn pressure that, in 1978, you, the FDA, failed to take the necessary steps to prevent what is happening today."

Moments late, I was interrupted by Connell who reminded me that I had three minutes remaining. This was to moment to pack in the clincher: "Dr. Kessler, what we all have been discussing here for the last two days is really a DRUG DELIVERY SYSTEM, and the drug is liquid silicone, the use of which has never been legalized. Therefore, a very elegant way for you to get out of your present predicament is to simply classify the implant as a drug delivery system." My statement was immediately followed by applause from the audience. Dr. Kessler quickly took the microphone and hushed up the audience by saying that if necessary, they were fully prepared to enforce order.

Connell interrupted again to inform me that my time was up. Now, with my feet firmly planted near the podium, I leaned still closer into the microphone and, looking directly at Connell, said: "Dr. Connell, I had the courtesy to wait while you and Mr. Tilton had your private conversation during my testimony. Now I would expect you show that same courtesy by letting me finish what I have to say." More applause. I quickly summed up my talk and sat down to more cheering and approval by an enthusiastic and fired-up crowd.

Dan Bolton was next to speak. In clear, logical terms he explained to the panel members that the jury in the case of Hopkins v. Dow Corning found Dow Corning guilty of fraud. He mentioned how at one point, Dow Corning had a count down of days to produce the implant. They could not meet the deadline, so they simply marketed the new implant anyway, in spite of not having properly completed the quality control.

Tom Talcott, chemical engineer, next spoke on silicone gel and its components. He had previously worked with Dow Corning but said he chose to leave the corporation in 1962 because he was unable to go along with what they were doing. He had observed in laboratory tests how the gel they were marketing was bleeding liquid silicone. He said, "Let's find out why," and they replied, "no, we'll just sell it. Tom Talcott was later employed by

Heyer-Schulte, which is when I first met him. Over the years I came to know him well and to respect his integrity.

Through the meeting, there were murmers passed that Tom Talcott had been fired. In addition, Dow Corning researcher, Dr. Robert LeVier, had publicly branded Talcott a "junk scientist." This of course, colored the opinions of Panel members prior to Talcott's testimony. Taking the bull by the horns, Talcott said, "Andy by the way, I want the Panel members to know that one of your members, and I know which one, has spread the rumor that I was fired. It is untrue and I expect a letter of apology."

Tom Talcott elucidated the dangers of making the envelope thinner and the gel less viscous in order to market a more natural feeling implant. He pointed out that women would be exposed to more and more liquid silicone, and that the thin envelope would break much easier exposing body tissue directly to the silicone gel.

Dr. Mike Resch, a mechanical engineer at the University of Nebraska, said in clear and simple terms that the silicone gel implants were never made for longevity. "They were designed to last between five and seven years.

The last speaker was Dr. Pierre Blais, undoubtedly the most knowledgeable Biochemist in North America, who possesses a formidable background in the field of silicone prostheses. He held the job as director of the Canadian

equivalent of the FDA. In 1991 he had declared the polyurethane covered breast implants to be dangerous and prohibited the sale of the product in Canada. Due to direct pressure from Surgitek, a Minnesota-based manufacturer of polyurethane covered breast implants and its main distributor in Montreal, as well as pressure from Bristol-Myers Squibb, he had to resign from his job. Over the last fifteen years, Dr. Blais has accumulated a great number of explanted breast implants of all varieties. He discovered that one group obviously showed gross rupture, another showed small areas of abrasion and areas of impending failure. Many of the cultures obtained from these implants that are sent to him from all over the world, are positive for staphylococcus epidermidis, staphylococcus aureus, Escherichia coli and others. Furthermore, he has discovered fungus growing

in implant material.

The audience once again broke into laughter and applause when Piere Blais, in his brilliant yet benign manner, apologetically stated, "Members of the Panel, I'm afraid that if the implant were a horse, you would have to shoot

it." Despite all the setbacks, the hearing was a success, although I am sure the press did not fully grasp the extent of the scandal. There were some women in the audience who taped it. The Advisory Panel voted to take the silicone gel implant off the market, except for use by a few breast surgery patients in controlled studies. They declared that the only legally available breast prosthesis was the saline-filled inflatable implant. What was the cause of this success? Certainly not the few of us who told the truth.

It was tanks to the women and the lawyers. The voting members of the Panel had read the newspapers, watched television and listed to the radio. They knew hundreds of women were seriously ill and they had heard from attorney Dan Bolton that $6.5 million of the $7.3 million dollars awarded by the jury to Marianne Hopkins represented Punitive damages and not compensatory damages for her enormous medical expenses. Why? Because the jury found Dow Corning guilty of fraud. Still no one acknowledged that the manufacturers had done anything wrong. No apologies came forth.

On the second day of the hearing, Dow Corning had announced that they would spend any amount of money on research. On the third day, one Panel Member made a motion regarding the permissibility of the use of the gel-filled breast implants. The chairwoman, Connell, was asked to repeat it so that the motion could be seconded. Not for all the tea in China was she able to repeat that simple motion. After her second unsuccessful attempt, she

capitulated and someone else had to restate it. A well-trained parakeet would have done much better.

After the Advisory Panel voted down the gel implants and the FDA backed their decision, Dow Corning stated at a press conference that they would NOT make their implant anymore. So much for the promise made only the day before when Dow announced their eagerness to spend any amount of money on research! It was time to move on and make their millions in other areas.

To be sure, Dr. Kessler is in a very difficult situation. What this country desperately needs is to replace Kessler with a capable person who also possesses the principles and integrity necessary to withstand any amount of pressure from powerful entities. The government is supposed to protect the consumer and if that breach is mandate, they become of negligence, even fraud and criminal conduct.

[Retyped from the book, "Siliconegate" - by Henry Jenny MD - pages 225 - 238]