MCG000133044/911
Mar 18, 1993 08:59 317-496-8065
DOW CORNING CORP
This study was funded by the top five breast implant manufacturers.
Study of Adjuvant Effect of Silicone Gel
As part of the ongoing research
program on silicone gel breast implants, Dow Corning on March 9, 1993 completed a laboratory study designed to test the adjuvancy
of silicone gel in laboratory rats. The study replicated one which will be published later in March 1993 by Dr. John Naim
of Rochester General Hospital, Rochester, NY, and Dr. Carol Van Oss and colleagues of the State University of New York, Buffalo.
Dow Corning and Dr. Naim’s
studies concluded that under specific experimental conditions silicone gel can function as an immune adjuvant in laboratory
rats. An adjuvant is a substance that can enhance the immune response to a foreign material (such as a protein). In these
two studies the adjuvancy of silicone gel was demonstrated by an increased production of antibodies in laboratory rats when
an antigen called ESA (borne serum albumin) was mixed with the gel and administered to the rats.
The heightened antibody production
caused by silicone gel acting as an adjuvant in these laboratory experiments does not mean that silicone causes immune disease.
The experiments also do not determine whether silicone gel could function as an adjuvant in women with silicone gel breast
implants. Additional research is required to address those issues, which Dow Corning is committed to pursue. More specifically,
some of our additional studies prompted by these findings address the following issues:
• The physical form
of the gel used in these laboratory rat studies differs markedly from its physical form in a breast implant. Dow Corning currently
is conducting additional research using gel which more closely resembles the physical form of gel actually used in implants.
• In the laboratory study,
silicone gel was mixed with a foreign material known as an antigen. However, silicone gel implants do not have an antigen
mixed in with the material. A key question is whether silicone gel can cause an increased production of antibodies in the
absence of this added antigen. Dow Corning currently has studies underway to address this question and additional studies
are planned.
“We have briefed the FDA on
these results and will continue to brief them about ongoing research as it is completed,” commented Myron Harrison,
M.D., Dow Corning’s Chief Medical Officer. “We believe our first responsibility to the women who have our implants
is to continue our research and report the results to the Food and Drug Administration. We will continue state-of-the-art
scientific studies so that physicians and the Agency can provide informed advice to patients.”
Adjestate:kkw
Lf/do
March 17, t993
