Note from Ilena Rosenthal: For some reason ... this study got buried
...

www.BreastImplantAwareness.org

WOODBRIDGE, N.J., Dec. 29,95 /PRNewswire/ -- A recently released
medical study conducted by some renowned plastic surgeons gives
further
evidence of a link between silicone breast implants and autoimmune
disease. The study looked at women who decided to have their silicone
breast implants taken out (Explantation Group) and compared them to
women who decided to keep their implants (Observation Group).

According to the study: "Systemic symptoms were eliminated or
improved in 79%% of 39 women who underwent explantation plus
capsulectomy. In contrast, 88%% of 16 Observation Group patients
remained unchanged or worsened."

"Our data suggest that explantation may be more effective in
relieving connective tissue disease-like symptoms in women who are
younger. Furthermore, a longer duration of implantation may result in
a
poorer outcome after explantation." Summary follows:

The Effect of Explantation and Capsulectomy on Symptoms and
Antibody
Levels in Women With Silicone Gel-filled Breast Implants.

V. Leroy Young, MD, Benjamin D. Schwartz, MD, PhD, Donna Phelan,
MT(HEW), CHS(ABHI), Marla Watson Schorr, MA

PURPOSE: This study was designed to determine the effect of
explantation on symptomatology and antibody levels in women with
silicone gel breast implants.

METHODS: Fifty-five women with breast implants were prospectively
evaluated for long-standing symptoms (of fatigue, breast pain,
myalgia/arthralgia, and/or generalized upper torso pain), capsular
contracture, implant integrity, autoantibodies to B cells, antinuclear
antibodies, and rheumatoid factor. Thirty-nine of these women
underwent
explantation because of concerns about implant safety, rheumatologic
symptoms, implant rupture, or capsular contracture. Sixteen other
women
elected not to have surgery but wished to remain under observation.
For
the Explantation group, the postsurgical follow-up period averaged
11.8
months. For the Observation group, the follow-up period averaged 17.0
months.

RESULTS: Results were analyzed by comparing women who had
undergone
explantation with those who chose observation. The two groups were
further categorized into subgroups: those who were
improved/asymptomatic and those who were unchanged/worse at the end of
follow-up. Results are shown in the table below. The study
demonstrates that explantation of silicone gel implants plus complete
capsulectomy resulted in symptomatic improvement in 79%% of the
Explantation group. Symptom relief was comparable regardless of
whether
a patient chose explantation only, reaugmentation with saline-filled
implants, or autologous tissue transfer. In contrast, 88%% of women in
the Observation group remained unchanged or became worse during the
follow-up period. As a whole, the Explantation group had a mean age
of
46, and the Observation group had a mean age of 49. In the
explantation
group, those who improved after surgery had a mean age of 44, while
those who remained unchanged had a mean age of 52. This may suggest
that younger women have a more favorable outcome after explantation;
alternatively, it could mean that patients who judged themselves to be
unchanged were suffering from symptoms associated with aging. The
mean
duration of implantation was 10.8 years in the Explantation group and
11.9 years in the Observation group. We found a disturbing
correlation
between the duration of implantation and symptom improvement. In the
explantation group, women who improved after surgery had implants for
a
mean time of 10.1 years, while those who did not improve had implants
for a mean of 13.7 years. In the Observation group, the two patients
who improved during the follow-up period had implants for a mean of
7.0 years; those who remained unchanged had implants for a mean of
12.6 years.

Patient %% of Fatigue Breast pain Myal/Arth
Group group Pre/post Pre/Post Pre/Post
Pre/Post

Explantation(n=39)
Improved(31) 79%% 97%%/26%% 68%%/10%% 94%%/29%%
Unchanged(8) 21%% 100%%/100%% 63%%/63%% 100%%/100%%

Observation(n=16)
Improved(2) 12%% 50%%/0 50%%/0 100%%/0
Unchanged(14) 88%% 71%%/79%% 71%%/71%% 88%%/88%%
Patient Gen Pain AutoX+ ANA>80 RF+
Group Pre/Post Pre/Post Pre/Post
Pre/Post

Explantation(n=39)
Improved(31) 26%%/10%% 53%%/23%% 31%%/27%% 13%%/0

Unchanged(8) 50%%/38%% 13%%/0 14%%/29%% 0/0

Observation(n=16)
Improved(2) 0/0 100%%/50%% 0/0 0/0
Unchanged(14) 43%%/43%% 38%%/0 8%%/8%% 17%%/8%%

CONCLUSION: Systemic symptoms were eliminated or improved in 79%%
of
39 women who underwent explantation plus capsulectomy. In contrast,
88%%
of 16 Observation group patients remained unchanged or worsened. Our
data suggests that explantation may be more effective in relieving
connective tissue disease-like symptoms in women who are younger.
Furthermore, a longer duration of implantation may result in a poorer
outcome after explantation.