In the Netherlands, 20.000-30.000 silicone breast prostheses (SBP) are placed annually.
Concern about possible complications and health risks is a recurring subject in practice. This
has been sparked by the scandal surrounding the Poly Implant Prothèsen (PIP). This manifests
itself in complaints of pain and fear of leakage of silicone gel. Until recently, a national
implant registry was missing and therefore consequently clear information for patients. Local
registration in the Medical Center of Leeuwarden (MCL) provides us with access to
information about complaints, complications and explantations. In this retrospective study, we
determine the frequency of these variables in the patients with SBP from the fourth and fifth
Through retrospective patient file research, both patient data and data of the implantation
procedure and implanted breast prosthesis were retrieved. This has been done for 738 primary
implanted SBP in 448 patients, operated during the period February 2003 to November 2015.
Complaints (subjective), complications (objective) and explantations occurring later than
three months after the implantation procedure were documented. Based on this, the frequency
of the most common complaints and complications was calculated for patients who have
undergone a cosmetic or reconstructive breast surgery. Also, possible associations with the
different types of SBP, placement methods and reconstruction methods has been tested.
Finally, the leading indications of the explantations were mapped out.
Within the cosmetic (median follow-up 193 days) and reconstructive (median follow-up 547
days) group, respectively 15,0% and 21,1% of the SBP gave postoperative complaints. In the
cosmetic group, the top three complaints were discomfort and pain (10,2%), fear or unrest
(6,7%) and other changes of the breast (1,5%). In the reconstructive group, the top three
complaints were discomfort and pain (16,0%), fear or unrest (5,1%) and dissatisfaction with
the feel of the SBP (4,3%). Within the cosmetic and reconstructive group, respectively 9,8%
and 20,6% of the SBP gave postoperative complications. In the cosmetic group, the top three
complications were palpable and/or visible SBP (4,8%), rippling (4,2%) and capsular
contracture (2,5%). In the reconstructive group, the top three complications were capsular
contracture (9,3%), palpable and/or visible SBP (4,7%) and rotation (4,2%). A total of 11,7%
of the SBP were explanted, with cosmetic reasons followed by capsular contracture as the
most common indications. Perioperative macroscopic leakage was observed in 0,4% (N = 3)
of the SBP.
Within the reconstructive group, significantly more SBP gave rise to postoperative complaints
and complications compared to the cosmetic group. In both the cosmetic and reconstructive
group, discomfort and pain of the operated breast was the most common complaint. Within
the cosmetic and reconstructive group, the most common complication was respectively a
palpable and/or visible SBP and capsular contracture. Both the complaint discomfort and pain
as the complication capsular contracture were significantly more commonly reported within
the reconstructive group. Complaints and complications have led to the necessary
explantations, which occurred significantly more frequent within the reconstructive group.
Only a very low number of all explanted SBP showed perioperative macroscopic leakage.
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