Replacement surgery and silicone gel breast implant rupture: self-report by women after mammoplasty.
BACKGROUND
This study examined the prevalence of revision surgery in which silicone gel breast implants were either removed (explanted) or replaced in a cohort of women from Birmingham, Alabama. The main reason leading up to the surgery and the prevalence of ruptured implants reported after explantation are described.


METHODS
Data were collected from telephone interviews with 907 women previously identified in a larger cohort study of women with breast implants. Women who reported breast surgeries subsequent to their index mammoplasty were asked to consent to retrieval of the surgical records describing the surgery.


RESULTS
Surgery in which a silicone gel breast implant was removed or replaced was reported by 33% of the 907 women in this cohort. The most common reason for surgery was problems with the implant that affected the breast (103 of 303 surgeries). Of the 303 women reporting surgery, 145 (48%) reported knowing after a surgery that an implant was ruptured when it was removed, and 171 (56%) reported knowing that an implant was ruptured or leaking. Overall, 16% of the 907 women reported knowing that either of their implants was ruptured after any surgery. At least one surgical record was retrieved for 165 (54%) of the 303 women reporting surgery. Among these women, the rupture rate was 69 of 165 (42%) according to the surgical record and 85 of 165 (51.5%) according to self-reports, a statistically significant difference (p = 0.008 from McNemar's test). The mean time from implantation to surgery was 11.5 years among women reporting surgery and estimated at 21.4 years for all women.


CONCLUSIONS
A third of the women in this cohort underwent additional surgery after the initial mammoplasty, and nearly half who underwent surgery reported that their implants were found to be ruptured when removed. Women considering silicone gel breast implants should be informed of the risk of additional surgeries and of the potential risk of breast implant rupture.
Brown
S Lori
SL
Epidemiology Branch, Division of Postmarket Surveillance, Center for Devices and Radiological Health, Food and Drug Administration, Rockville, Maryland 20850, USA.
Pennello
Gene
G
D000328:Adult; D000407:Alabama / Q000453:epidemiology; D019928:Breast Implantation; D018427:Breast Implants; D015331:Cohort Studies; D019544:Equipment Failure Analysis; D005260:Female; D005500:Follow-Up Studies; D006304:Health Status; D006801:Humans; D008875:Middle Aged; D011183:Postoperative Complications; D012086:Reoperation; D012422:Rupture, Spontaneous / Q000453:epidemiology / Q000209:etiology / Q000601:surgery; D020034:Silicone Gels
D020034:Silicone Gels