Reconstructive Breast Implantation After Mastectomy
Archives of Surgery, Vol 141, July 2006, pages 714-715
Diana Zuckerman, PhD
Henriksen et al1 provided useful data
on the short-term complications of breast reconstruction with implants.
Although the invited critique described the complication rate as
"alarmingly high and arguably unacceptable," the complication rate
is even higher in other studies with superior study designs.
For example, a study conducted by implant manufacturer Inamed found
that 46% of reconstruction patients needed additional surgery within
the first 2 to 3 years after getting silicone gel breast implants2
- more than twice as high as the 21% reported by Henriksen et al.
One explanation is that the women in the Henriksen study had breast
implants for an average of only 23 months, compared to 2-3 years
in the Inamed study. Henriksen et al reported that 31% developed
at least one serious complication and 16% developed at least 2 serious
complications. The Inamed study reported that 25% underwent implant
removal, 16% experienced Baker III-IV capsular contracture, 6% experienced
necrosis, 6% had breast pain, and 6% had scarring, in addition to
infections and other complications.2
Henriksen et al concluded that "reconstruction failure (loss of
implant) is rare." However, in addition to the short follow-up,
Henriksen et al did not use Magnetic Resonance Imaging (MRIs) to
detect rupture, thus undercounting the number of ruptures according
to the FDA.3 A study using MRIs found
that 20% of reconstruction patients had ruptured implants by the
third year;4 very few ruptures were
detected without MRIs. Food and Drug Administration scientists concluded
that the risk of rupture would likely increase exponentially every
year.
Henriksen et al's lack of MRI use also helps explain the lower rate
of additional surgery. If a woman underwent an MRI and learned that
her implant was ruptured, she would probably have surgery to remove
it.
In his critique, Singh states that "the immunologic and systemic
complications ascribed to implants (silicone or saline) have been
debunked by the Institute of Medicine's 1999 definitive report."
However, most research on diseases among implant patients was published
after 1999. The IOM report included only 17 studies of autoimmune
diseases among implants, almost all of which studied small numbers
of women for short periods of time. Many of the studies reported
higher levels of disease or symptoms among women with breast implants,
which would have reached statistical significance if maintained
in larger studies conducted for a longer period of time. For example,
the study by Schusterman et al, included only 250 women with implants,
all of whom had implants for 2 years.
In 2001, Food and Drug Administration scientists reported a significant
increase in fibromyalgia and several other autoimmune diseases among
women whose silicone gel breast implants were leaking, compared
to women with silicone implants without extracapsular leakage.3
The National Cancer Institute (NCI) found a doubling of deaths from
brain cancer, lung cancer, and suicides among women with breast
implants compared to other plastic surgery patients.5
National Cancer Institute findings regarding autoimmune diseases
were not definitive.6 National Cancer
Institute scientists concluded that more research was needed to
determine if implants increase the risk of cancer or autoimmune
diseases.5,6
The unanswered questions about diseases and the high complication
rate for breast cancer patients raise important safety issues about
breast implants. It is difficult for patients to receive informed
consent when definitive long-term data are not yet available.
References:
1 Henriksen TF, Fryzek JP,
Holmich LR et al Reconstructive breast implantation after mastectomy
for breast cancer: clinical outcomes in a nationwide prospective
cohort study. Arch Surg. 2005; 140: 1152-1159.
2 Inamed Corporation's McGhan
Silicone-Filled Breast Implants, October 14-15, 2003, slides presented
by the FDA, http://www.fda.gov/ohrms/dockets/ac/03/slides/3989s1_02-update_files/frame.htm
3 Brown SL, Pennello G,
Berg WA, et al. Silicone gel breast implant rupture, extracapsular
silicone, and health status in a population of women. Journal
of Rheumatology. 2001; 28:996-1003.
4 FDA Summary Memorandum,
Inamed PMA Review Team, March 2, 2005., http://www.fda.gov/ohrms/dockets/ac/05/briefing/2005-4101b1_tab-1_fda-Inamed%20Panel%20Memo.pdf
5 Brinton LA, Lubin, JH,
Murray MC, et al. Mortality among augmentation mammoplasty patients:
an update. Epidemiology. 2006; 17: 162-169.
6 Brinton, LA, Buckley,
LM, Dvorkina, O et al. Risks of connective tissue disorders among
breast implant patients. American Journal of Epidemiology.
2004, 180: 619-627.
