Breast Implant Morbidity
For
more than a decade, breast implant morbidity has been the subject of much controversy
in both the public and medical profession alike. Implants that had been used
for breast augmentation and breast reconstruction for nearly thirty years were
suddenly forced off the market by the Food and Drug Administration amidst reports
that the silicone-filled implants caused a multitude
of chronic, life-threatening diseases. (litigation)
Lawsuits followed by the hundreds, and major implant manufacturers soon found
themselves in major legal battles. Patients alleged that the implants had caused
their cancer, arthritis, or other chronic illnesses. Insufficient study and
questionable professional testimony led to a judgement in favor of the patients
and the downfall of at least one major silicone implant
manufacturer. Interestingly, however, with the litigation concluded and the
patients compensated , the issue of implant morbidity has recently received
little or no coverage from the media. This is unfortunate since the issue of
implant morbidity has only recently begun to be clarified. However, does breast
implant morbidity really exist? And if it does exist, how does it occur?
Exploring these questions further primarily necessitates clarifying the silicone
breast implant controversy.
Starting in the mid 1980’s, reports surfaced linking silicone
from breast implants to various chronic illnesses and connective tissue diseases.
Among the first of these illnesses allegedly cause by silicone was breast cancer.
Stemming from studies in which silicone was proven to stimulate sarcoma in rats1,
early reports suggested that silicone would perhaps increase the risk of breast
adenocarcinoma. Furthermore, reports "supporting" the possible cancer
risk often included the study of only two or three implant recipients in which
the authors merely speculated that the cancer may or may not have been caused
by the implant itself.2 Soon thereafter (late eighties, early nineties),
silicone implants were suspected of predisposing recipients to rheumatoid arthritis,
auto-immune disease, and connective tissue disorders by serving an "adjuvant"
role in the development of these diseases.3 However, as early as
1993, British scientists A.J. Park et al. published studies showing no link
between silicone implants and cancer. In addition, a 1995 study published in
The New England Journal of Medicine by Jorge Sanchez-Guerrero et al.
revealed that there was no association between silicone breast implants and
connective tissue disease. This study is quite interesting because it involved
a nurses’ health study cohort assembled in 1976, where biennial health questionnaires
were mailed to the nurses in various states for nearly twenty years. The study
included a little over 100,000 women who provided dependable health data before
the implant controversy exploded in the media. Furthermore, the study also rejected
association between connective tissue disease and saline-filled implants.4
More recent studies have also found evidence against the onset
of connective tissue disease in implant recipients and against a connection
between silicone implants and auto immune disease. Esther C. Janowsky et al.
found "no evidence of an association between breast implants in general,
or silicone-gel-filled breast implants specifically, and any of the individual
connective tissue diseases, all definite connective-tissue diseases combined
, or other autoimmune or rheumatic conditions".5 The connection
between rheumatoid arthritis and implants was also proven to be erroneous by
Wolfe and Anderson in a 1999 paper in The Journal of Rheumatology. However,
in the same paper, Wolfe and Anderson also make a crucial correlation. The two
scientists reported that fibromyalgia was indeed more prevalent among patients
who had received breast implants.6 Fibromyalgia, defined as a disorder
characterized by muscle pain and easy fatigability, is important in understanding
what constitutes real breast implant morbidity.
So far, it has become evident that breast implants (silicone
or saline) are not responsible for chronic diseases such as cancer or arthritis.
In fact, breast implant morbidity is related much more to the local, 
physical
consequences of implantation rather than to the chemical components of the implants
themselves. The major problems with breast implants include possible bleeding,
infection, capsular contracture (pain from scarring), and complications due
to the tearing or rupturing of the implant themselves. In addition, there are
the risks associated with undergoing multiple surgeries. A 1997 implant recipient
study by Sherine E. Gabriel et al. showed that 27.8% (of 750) women underwent
additional implant-related surgical procedures approximately 8 years after implantation.
Eighty percent of these additional procedures were due to complications such
as capsular contraction, implant rupture, hematoma and wound infection.7
While Gabriel et al. did conclude that within the first five years of implantation
the probability of complications was low, the chances of complication increased
fourfold after five years. However, a more recent and extensive study by James
S. Marotta, et al. takes into account data from 35 different studies encompassing
more than 8000 explanted silicone breast implants and provides more accurate
data on the failure of silicone implants.
This study found failure of silicone breast implants to be 6% within the first
five years following surgery, 30% at five years, 50% at ten years, and 70% at
17 years.8 These are the highest, yet most accurate (due to the enormous
amount of data) failure rates among all of the studies discussed thus far. These
numbers further demonstrate the need for additional studies regarding the local
complications caused by breast implants. "Epidemiology and immunology studies
and editorial articles that have been cited in support of silicone gel breast
implant safety have devoted almost no attention to the health consequences of
the local complications of pain, capsular contracture, disfigurement, chronic
inflammation, rupture, silicone migration, and frequent surgical revisions."9
As a result, true breast implant morbidity lies in the local complications of
implantation/explantation rather than in the systemic, chemical maladies of
the implant-filling substances themselves.
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