An outcome analysis of 100 women after explantation of silicone gel breast implants

A prospective outcome analysis was conducted on 100 consecutive
women who requested explantation of their silicone gel breast
implants from January 6, 1992 (the moratorium), through 1995.

Eighteen patients were referred by rheumatologists with a
diagnosis of autoimmune or rheumatic disease. Six had
autoimmune disease (systemic lupus, 2 patients; rheumatoid
arthritis, 2 patients; multiple sclerosis, 1 patient; and
Raynaud's disease, 1 patient). Twelve had rheumatic disease
(fibromyalgia, 10 patients; inflammatory arthritis, 2
patients). All of these 18 patients had developed symptoms of
their disease after they had received implants.

All 100 patients were extensively evaluated pre- and postoperatively
by interviews, clinical assessment, and by assay of the
following laboratory tests: rheumatoid factor, ESR, ANA, and
anti-Ro/SSA, -La/SSP, -Sm, -RNP, -double-stranded
deoxyribonucleic acid, -Scl-70, -centromere, and -cardiolipin.
Patients were also evaluated by a questionnaire that was sent
at a mean time of 2.7 years postexplantation (range, 1-5
years), which had a 75% response rate. Reasons for implants
were augmentation, 75%; lifting, 11%; reconstruction, 12%; and
congenital aplasia, 2%. The mean age at first implant was 28.9
years (range, 13-55 years) and at explantation was 41.5 years
(range, 25-65 years). The mean duration of implantation was
12.0 years (range, 1-27 years).

Thirty-six percent of the patients had undergone at least one closed
capsulotomy and 54% at least one open capsulotomy. The mean
reasons for explantation were suspected silicone-related health
problems, 76%; suspected rupture, 59%; breast firmness, 36%; breast
pain, 36%; and musculoskeletal pain, 23%. Before explantation
75% of the questionnaire respondees had lost some sensitivity
in their nipples following their breast augmentation. In 36%
of those 75 patients, that loss was almost complete. Loss of
sensitivity was related to capsular contracture and to pain (p
< 0.05). Following explantation there was significant
improvement in nipple sensitivity in 38% of breasts in the 75

A total of 186 implants were removed. Fifty-seven
percent had failed by rupturing or leaking. Only 3.2%
demonstrated extravasation extracapsularly. Twenty-five
percent of the capsules were calcified, demonstrating visible
plaques of calcification on their inner surface. Forty-two
percent were colonized by bacteria. The prevalence of class
III-IV capsular contracture was 61% and it was related to
implant location, duration in situ, and capsular calcification
(p < 0.05), but not to capsular colonization or implant
integrity (p > 0.05). Only 43 of the 100 patients elected to
have saline implants inserted. Of the others, 56% felt that
the shell of the saline implant could be associated with
medical problems. The others felt that breast size was of
minor importance to them at this time. There were few
complications from the explantation procedure. Two "masses"
were discovered-one was an occult carcinoma, the other a
galactocele. There was one wound infection, which responded to
antibiotics. Three patients developed decreased sensitivity
and 3 developed increased breast pain.

From the patient questionnaires, in those women who did not have
saline implants inserted, 15% felt that their breast appearance was
improved after explantation, 36% were "pleased," 33% were
disappointed, and 13% felt "mutilated". In women who did have
saline implants inserted, 18% felt that their breast
appearance was now improved, 60% were "pleased," and 14% were
disappointed, mainly because of wrinkling. At a mean time of
2.7 years (range, 1-5 years) after explantation, 45% of the 75
questionnaire respondees felt that their implants had caused
permanent health problems and 56% felt that they had not been
given adequate informed consent by their original surgeon
(particularly regarding implant rupture and a possible
relationship to medical disease). (ABSTRACT TRUNCATED)

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