Research Article: Comparative clinical evaluation of breast augmentation using silicone foam coated implants and textured implants1

Date Published: June 12, 2020

Publisher: Sociedade Brasileira para o Desenvolvimento da Pesquisa em Cirurgia

Author(s): Ivana Leme de Calaes, Marcos Matias Motta, Rafael de Campos Basso, Davi Reis Calderoni, Paulo Kharmandayan.


To evaluate whether silicone foam implants have a different evolution pattern compared to conventional texture implants.

Fifty-eight female patients underwent surgery. They were divided into two groups (silicone foam – Lifesil® – and microtexturized silicone – Lifesil®). The evolution was analyzed in postoperative consultations, with physical examination, photographic documentation and filling in a satisfaction questionnaire, in the postoperative period of one month, four months, one year and then annually, up to a maximum of 3 years of follow-up.

There were no statistically significant differences in presence of rippling, stretch marks, breast ptosis, capsular contracture and quality of scars. There was a higher rate of patients who were very satisfied with the outcome 360 days after surgery in the group receiving silicone foam implants (p = 0.036).

In short time, silicone foam envelope implants proved to be as reliable as textured silicone envelope implants, making them an option for augmentation mammoplasty.

Partial Text

Breasts have always occupied a prominent place in female body aesthetics, acting on sensuality and improving women’s self-esteem. In the past, small breasts were the desire of the majority, but in recent decades there has been a change in the concept of beauty in this body segment, with women with larger breasts and a more marked upper pole, due to the use of implants in the media. Therefore, breast augmentation is the most performed plastic surgery in Brazil today, reaching 197.577 procedures in 2018, according to the Brazilian Society of Plastic Surgery (18.8% of cosmetic surgeries performed). There is also an increasing number of surgeries for breast fat grafting, helping to improve body contouring, in addition to the possibility of obtaining more favorable aesthetic results in cases of breast reconstruction after cancer and other thoracic deformities.

Prospective randomized clinical trial (after approval by the UNICAMP Ethics Committee). 60 patients with a minimum age of 18 years old and complaints of hypomastia were selected at the UNICAMP Clinical Hospital, whose inclusion criteria were an indication of breast augmentation with implants silicone. The minimum number of patients in the sample was determined by the university’s statistics department. Patients who had underwent previous inclusion of breast implants, patients with mastectomy sequelae, pregnant women, patients with mammary ptosis (who required mastopexy), and those with breast abnormalities or nodules with BI-RADS classification 4 or higher in the preoperative ultrasonography and/or mammography were excluded.

The surgeries were performed between July 2014 and March 2017; in this period, two patients were excluded, one belonging to group A and the other to group B, for different reasons: pregnancy and loss of follow-up, respectively. Thus, the statistical analysis was held with n=58 patients. Analysis consists of 58 patients whose postoperative minimal follow-up period was 1 year, 38 patients whose postoperative minimal follow-up period was 2 years, and 16 patients whose postoperative follow-up period was 3 years.

The characteristics of an ideal implant were defined by Scales9 in 1953. The Silastic® prosthesis was produced with the purpose of solving the problem of silicone leakage through the implant’s wall and of detachment of silicone molecules. Its membrane was supposed to be impermeable between the silicone layers. The studies by Cronin and Gerow1 were the ones responsible for the development and dissemination of the use of silicone gel breast implant.

Silicone foam envelope implants proved to be as reliable as textured silicone envelope implants, making them an option for augmentation mammoplasty.




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