Trilucent breast implants: voluntary removal following the Medical Device Agency recommendation. Report on 115 consecutive patients.
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.
Gherardini
Giulio
G
Department of Physiology and Pharmacology, Karolinska Institutet, Stockholm, Sweden. gighera@tin.it
Zaccheddu
Renato
R
Basoccu
Giulio
G
D000328:Adult; D018427:Breast Implants; D020878:Device Removal; D005260:Female; D006801:Humans; D008875:Middle Aged; D011358:Product Surveillance, Postmarketing; D011474:Prosthesis Design; D011475:Prosthesis Failure; D012189:Retrospective Studies