DCCKKA031147-Thomas Talcott-1990 

PREPARED STATEMENT CONCERNING THE SAFETY AND EFFECTIVENESS

OF SILICONE BREASTS PROSTHESES

Prepared for the Human Resources and Intergovernmental Relations Subcommittee, United States House of Representatives.

                                                                                                            December 14, 1990

By       Thomas D. Talcott
Laguna Niguel, CA                                    

My name is Tom Talcott.  I am pleased to have the opportunity to testify about the safety and effectiveness of silicone breast prostheses and research studies that are needed to assure safety.  I am qualified to testify about many aspects of silicone breast prostheses as an involved materials engineer and consultant concerned about the severe damages to women of which I am aware.  My testimony is based upon my experience over the entire evolution of the mammary prostheses.  The time frame is from the original firm consistency silicone gel filled “Cronin” device (1963) to the dangerous low consistency fluid gel filled devices we are using today.  If you wish and time permits, I am prepared to show samples.

1952-1973:    As a Dow Corning Materials engineer involved with silicone materials during the start up of the Medical Products business.

1973-February 1986:   As a development engineer in the Medical Products Business, Product Development Group, Dow Corning Corp.

        To July 1978:   As Director of Materials   
        Research, American Heyer-Schulte Corp.

To December 31, 1981:  As Improved Mammary Prostheses Project Director, DePuy (Div of Boehringer Mannheim Corp.)

To present:  President, Talcott Development, Inc. (A highly profitable materials research, testing and consulting company and; Consultant to litigants in medical devices (Talcott Consulting). Approximately 80 cases to date.

In all of the above situations, day to day activities have given me important understanding and opinions concerning the mechanisms of failure of devices from both a mechanical and biological point of view.  I sincerely hope that all of the testimony at this hearing will contribute to more forceful public warnings to recipients, prospective recipients and surgeons and to the development of safer improved devices.

THE MIGRATION OF FLUID CONSISTENCY SILICONE GEL

I testified before the FDA General and Plastic Surgery Devices Panel in November 1988.  I presented two letters that indicated patients and surgeons did not understand the hazards of liquid silicone gel. That when devices rupture, liquid silicone gel can migrate to the lower arm and/or the groin area and that clear public warnings should be give to recipients, prospective patients and surgeons.  There have been no reasonable public warnings since.  In the intervening two (2) years, I have been retained in additional litigation where surgeons were unaware of the hazards and performed closed capsulotomies with disastrous results.  A closed capsulotomy is a painful squeezing of the breast to tear the fibrous capsule to soften a hard contracted breast.

THE MOVEMENT OF LIQUID SILICONE GEL IN THE BODY

I first became aware that the consistency (fluidity) of silicone gel could be detrimental to the health of an implant patient in 1973.  Dicran Gouilian Jr. M.D. suggested that a gel that would not be phagocytized (a process where cells ingest foreign materials for digestion) would be the safest implant.  My management felt such studies were not required because of all the implants data already performed and declined to make such studies.

Four (4) years passed before a range finding study with 15 cc boluses of silicone liquid and various consistency gel in tissue planes was performed.  It was found on autopsy that the silicone fluid and fluid silicone gels were accumulated as droplets in the vital organs.  Gel firmer than that being used in implants was easily transferred.  I am aware of no other studies published or unpublished.

SILICONE OIL THAT WEEPS THROUGH THE SHELL MEMBRANE – “BLEED”

Silicone prostheses bleed has been a concern since the early to mid 1970’s.  An accelerated test to determine the amount of silicone that would come from a device was demonstrated by DePuy in 1980 to a large group of plastic surgeons. I am prepared to demonstrate this membrane pumping phenomenon for you if you wish and time permits.  This technique also allows for the collection of sufficient quantities of “bleed” that animal studies and human sensitivity studies could be performed.  I am aware of no studies published or unpublished.  I can also slow you the amount that collects by gravity over a period of seven (7) years to eight (8) years.

HOW SILICONE GEL CONSISTENCY CONTRIBUTES TO ENVELOPE RUPTURE

The mechanism of rupture was first suggested in a paper by Garry Brody, M.D. in Boston, 1978.  Unfortunately this work was never published.  It described the hydraulic effect which allows the stretching of the biological capsule to rupture which softens the hard contracted breast.  It was subsequently found that more firm gels, that were aesthetically acceptable when implanted, could not be softened by closed capsulotomies (DePuy market trial users 1981).  I am prepared to demonstrated (sic) the rupture mechanism if you wish and time allows.

ADDITIONAL COMMENT AND RECOMMENDATIONS

I have testified under oath that the manufacturers and surgeons have been performing experimental surgery on humans with the standard fluid gel devices introduced in the early to mid 1970’s to the time when their warnings became realistic and include the complications known today.  This occurred in spite of the warnings to surgeons given by American Heyer-Schulte in August 1976.  This is up to a dozen years in the case of some manufacturers.  The cause of the difficulties was the change in silicone gel consistency to fluid gels.  Another hint of difficulties at the time was the mid 1960’s ban of injection of silicone fluids.

I am disappointed by nor surprised that my from my perspective, I see only protectionist effort for the continued use of the gel filled mammary prostheses when there are so many possibilities for scientific work to help define better performing devices.

I am disappointed that surgeons accept the manufacturers statements that all silicone prostheses are the same from 1970 to 1980 as justification to treat them as a single statistical group (Weisman, Vicchione et al). In reality, there were at least 5 suppliers of silicone gel using different manufacturing processes and therefore contain different impurities.  Today there are a different five (5) suppliers.  In addition, gels were being fabricated to different consistencies for devices by the various device manufacturers.

Very recently I have been contacted by women who claim systemic illness resulting from saline filled inflatables.  This would have to be due to the known impurities in the silicone rubber (elastomers).  If true, it should also raise some concern about long term effects of the recently announced implantable birth control made from silicone rubber and the specifications on that rubber.

Progress on understanding the device performance has been seriously slowed since the plastic surgeons, manufacturers and FDA have not aggressively pursued and used the technical expertise of all materials scientists and engineers.

In the last several years the safety and effectiveness controversy has stimulated my consideration as to how people can become sensitized to their own collagen to become involved with the collagen related disease.  Silicones transfer to the vital organs.  It appears then that ingestion by cells of ones collagen (contaminated with and recognized as silicone) occurs with time to cause sensitization to their collagen.  This is similar to reaction that occurs with inert foreign bodies when in particulate form.  As different types of collagen are sensitized different organ attack symptoms occur.

It is my opinion that FDA desperately needs an advisory panel composed of materials scientific and engineers to advise on materials related issues.

I have offered since January 1982 to consult with FDA, Plastic Surgeons, and others on technical details of silicone and device performance. This offer to all interested medical professional people remains.  I would also be interested in assisting in arranging for funds to do significant experimental work to develop tests for the definition of more suitable materials and devices.

It is my current opinion that as the number of damaged women are better defined along with a better definition of damages that a moratorium on implantations may be required until the safety of devices is improved.

End of Prepared Statement

Thomas D. Talcott 12/14/90