Recall management of patients with Rofil Medical breast implants.
BACKGROUND
Some Rofil Medical breast implants are relabelled Poly Implant Prothèse (PIP) implants, and it is recommended that Rofil implants be managed in the same way as PIP implants. We report the results of a systematic recall of patients who had received Rofil implants.


METHODS
All patients who received Rofil implants at our centre were identified and invited for specialist consultation. In patients who opted for explantation, preoperative and intraoperative work-up was performed in accordance with national guidelines and analysed. In cases suspicious for rupture, an MRI scan was performed.


RESULTS
Two-hundred and twenty-five patients (average age 56; range 28-80) received a total of 321 Rofil implants an average of 5.8 (range 1-11) years previously, 225/321 (70%) implants were used for reconstruction after breast cancer. A total of 43 implants were removed prior to 2011, mainly due to capsular contracture (CC). A total of 188 patients were still affected at the time of recall. Of the 188 patients, 115 (61%) attended for specialist consultation, of which 50 (44%) requested immediate implant removal. To date, 72 of 115 (63%) women attending consultation (38% of all affected) have chosen explantation, 66 of 72 (92%) opting for new implants. Of the 108 explanted implants, 25 (23%) had capsular rupture and 57 (53%) had implant bleeding. Preoperative clinical assessment was unreliable for predicting CC or rupture.


CONCLUSIONS
The majority of patients attended for consultation and requested explantation. The quality of the explanted Rofil implants was comparable to PIP implants, with a higher rupture prevalence compared with other, non-affected implants. Nevertheless, the acceptance of breast implants for reimplantation remained high.
University Hospital Heidelberg, Department of Gynaecology and Obstetrics, Im Neuenheimer Feld 440, 69120 Heidelberg, Germany. Electronic address: sarah.schott@med.uni-heidelberg.de.
Sarah
S
Schott
University Hospital Heidelberg, Institute of Biometry and Informatics, Im Neuenheimer Feld 440, 69120 Heidelberg, Germany.
Thomas
T
Bruckner
University Hospital Heidelberg, Department of Gynaecology and Obstetrics, Im Neuenheimer Feld 440, 69120 Heidelberg, Germany.
Michael
M
Golatta
University Hospital Heidelberg, Department of Gynaecology and Obstetrics, Im Neuenheimer Feld 440, 69120 Heidelberg, Germany.
Markus
M
Wallwiener
University Hospital Heidelberg, Department of Gynaecology and Obstetrics, Im Neuenheimer Feld 440, 69120 Heidelberg, Germany.
Livia
L
Küffner
University Hospital Heidelberg, Department of Gynaecology and Obstetrics, Im Neuenheimer Feld 440, 69120 Heidelberg, Germany.
Christine
C
Mayer
University Hospital Heidelberg, Department of Gynaecology and Obstetrics, Im Neuenheimer Feld 440, 69120 Heidelberg, Germany.
Carmen
C
Paringer
University Hospital Heidelberg, Department of Gynaecology and Obstetrics, Im Neuenheimer Feld 440, 69120 Heidelberg, Germany.
Christoph
C
Domschke
University Hospital Heidelberg, Department of Gynaecology and Obstetrics, Im Neuenheimer Feld 440, 69120 Heidelberg, Germany.
Maria
M
Blumenstein
University Hospital Heidelberg, Department of Gynaecology and Obstetrics, Im Neuenheimer Feld 440, 69120 Heidelberg, Germany.
Florian
F
Schütz
University Hospital Heidelberg, Department of Gynaecology and Obstetrics, Im Neuenheimer Feld 440, 69120 Heidelberg, Germany.
Christof
C
Sohn
University Hospital Heidelberg, Department of Gynaecology and Obstetrics, Im Neuenheimer Feld 440, 69120 Heidelberg, Germany.
Joerg
J
Heil
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D019928:Breast Implantation / Q000009:adverse effects; D018427:Breast Implants / Q000009:adverse effects*; D020878:Device Removal; D005260:Female; D005858:Germany; D006801:Humans; D057910:Implant Capsular Contracture / Q000209:etiology* / Q000601:surgery*; D057052:Medical Device Recalls; D008875:Middle Aged; D012086:Reoperation; D012828:Silicones / Q000009:adverse effects
D012828:Silicones
Breast cancer; Capsular contracture; Capsular rupture; Implant; PIP; Rofil