Trilucent Breast Implants: Voluntary Removal following the Medical Device Agency Recommendation. Report on 115 Consecutive Patients

Abstract

In June of 2000, the U.K. Medical Device Agency recommended the removal of Trilucent implants as a precautionary maneuver in response to reports of local inflammatory reactions. This decision allowed the authors to operate on 115 consecutive patients between June of 2000 and January of 2001. On the preoperative examination, the authors found a very high incidence of rippling (66 percent), whereas capsular contracture was seen in only three patients (2.6 percent). Rippling was significantly more common in patients with subglandular implants. Five implants were found ruptured during the operation. This figure, together with the relative ease of implant breakage at removal, shows a premature deterioration of the implant shell. The authors also comment on implant bleeding, which seems common in this type of breast implant. The authors think that this is a possible cause for the rippling phenomenon, resulting from a reduction of the implant content. On the basis of these findings, the authors conclude that Trilucent implants are associated with a poor cosmetic outcome and a high rate of complications.

Abordagem cirúrgica da reconstrução e aumento das mamas com implantes

“…Não houve diferença nas taxas de contratura capsular quando três dias de antibióticos orais (principalmente cefalosporinas) foram administrados em comparação com nenhum antibiótico. Técnicas de prevenção futuras podem se concentrar na prevenção e erradicação de biofilmes bacterianos de implantes (particularmente Staphylococcus epidermidis ), que têm uma forte ligação com a contratura capsular 11,12 .…”

Breast implants: the good, the bad and the ugly. Can nanotechnology improve implants?

“…Fueled by fears and uncertainty regarding the interactions and metabolic fate of free silicone within the body, the ‘silicone crisis’ of the 1990s led to the investigation of alternative implant filler materials. Although they were not widely used within the United States, implants made with alternative fillers (primarily soybean oil and various hydrogels) found their way into European operating rooms 25–27. USP medical grade soybean oil was used in the Trilucent device (Lipomatrix, Switzerland) which was implanted into 5000 women between 1995 and 1999 28.…”

“…Although they were not widely used within the United States, implants made with alternative fillers (primarily soybean oil and various hydrogels) found their way into European operating rooms. [25][26][27] USP medical grade soybean oil was used in the Trilucent device (Lipomatrix, Switzerland) which was implanted into 5000 women between 1995 and 1999. 28 The soybean oil was chosen because it was believed to be biocompatible, and provided a more natural feel and superior radiolucency for better imaging to screen for breast cancer.…”

Position statement of IQUAM

“…C. Long term follow-up of this group of patients is recommended even after explantation. General references [23][24][25][26][27][28][29][30][31][32][33][34][35][36][37][38][39][40][41][42] General recommendations for breast augmentation and reconstruction A. IQUAM believes it is important to advise patients of potential hazards and risks, the possible need for reoperations, as well as the benefits of breast augmentation or reconstructive surgery. A detailed and updated Patients Information and Consent Form must be provided and discussed with the patient prior to surgery.…”