Dataset Information

Five-Year Retrospective Analysis of Eurosilicone's Silicone Gel-Filled Breast Implants.

ABSTRACT:

Background

Silicone breast implants have been widely used for breast augmentation and reconstruction. During this time, silicone breast implants have undergone several modifications to improve their safety, quality, and clinical performance. Complications such as reoperation, capsular contracture, and rupture are risks often associated with breast implants.

Objectives

The authors conducted a retrospective study to analyze and report complication rates associated with Eurosilicone's (Eurosilicone S.A.S, Apt, Cedex, France) silicone gel-filled breast implants over a period of 5 years.

Methods

In this retrospective clinical study, 2151 women who underwent either breast augmentation or breast reconstruction with Eurosilicone breast implants were diagnosed. Data on early and late complications including implant removal (explantation/exchange), capsular contracture, and rupture were collected using questionnaires, completed by 39 surgeons across Italy.

Results

Of the 2151, only 60 patients (2.78%) required implant removal. Twenty-five patients experienced capsular contracture (Baker Grade III/IV), giving an actual rate of 1.2%. The actual rate of implant rupture confirmed by breast magnetic resonance images was 0.18% (4 implants). Six patients (0.27%) were diagnosed with breast cancer following breast augmentation, and local complications including hematoma (1 patient) and seroma (2 patients) were experienced.

Conclusions

This retrospective clinical study involving Eurosilicone's round and anatomical textured silicone gel-filled mammary implants demonstrates an excellent safety profile through 5 years.Level of Evidence: 2.

SUBMITTER: Saturno M

PROVIDER: S-EPMC7671275 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:ObjectiveAn unknown portion of women with silicone breast implants (SBI) report development of systemic symptoms, recently named as 'breast implant illness (BII)'. We aim to describe the symptoms and characteristics of women with SBI reporting these systemic symptoms and compare the clinical course of women who chose to keep their implants, to women who had their implants removed.DesignObservational cohort study.SettingSpecialised BII out-patient clinic at Amsterdam UMC, the Netherlands, from 2011 to 2020.ParticipantsAll women presenting to the BII clinic with SBI and systemic symptoms.Results467 women were included for baseline analyses and 398 women for follow-up. Most frequently reported systemic symptoms at baseline included fatigue (88%), arthralgia (71%), morning stiffness (59%), myalgia (48%), cognitive impairment (33%), peripheral neurological symptoms (30%) and lymphadenopathy (22%). Furthermore, 56% reported pre-existing allergies at baseline and positive antinuclear antibodies were observed in 23%. At follow-up with a median of 3.3 years (IQR 2-4), 152 women had their implants removed on clinical grounds. Symptoms improved significantly in 65 women (43%), improved moderately in 37 women (24%), did not change in 37 women (24%) and deteriorated in 13 women (9%). Women who underwent explantation showed more improvement of their systemic symptoms compared with women who did not (OR 2.9, 95% CI 1.3 to 6.2). Additionally, women who underwent explantation within 10 years after implantation improved significantly better than women who got the implants removed after 10 years (p=0.007). Lastly, local symptoms decreased from 75% to 34% after implant removal (p<0.0001).ConclusionMost women with SBI who developed systemic symptoms experienced improvement after explantation, especially when removed within 10 years after implantation. Early recognition of the pattern of systemic symptoms in women with SBI is important and implant removal should be considered.