Breast Implant Stability in the Subfascial Plane and the New Shaped Silicone Gel Breast Implants

2009 ◽  
Vol 34 (1) ◽  
pp. 23-28 ◽  
Author(s):  
João Carlos Sampaio Góes
Keyword(s):  
Breast Implant ◽  
Breast Implants ◽  
Implant Stability ◽  
Silicone Gel

The Silicone Gel Breast Implant Controversy—A Chronology of Recent Regulations and Decisions

1993 ◽  
Vol 10 (2) ◽  
pp. 89-93
Author(s):  
Howard A. Tobin
Keyword(s):  
Drug Administration ◽  
Breast Implant ◽  
Breast Implants ◽  
Press Coverage ◽  
Silicone Breast Implants ◽  
Consumer Activism ◽  
Silicone Gel ◽  
Congressional Investigations ◽  
Regulatory Actions

This article summarizes the regulatory actions of the Food & Drug Administration as related to gel-filled silicone breast implants. It also relates the actions to the influences of outside forces such as press coverage, congressional investigations, and consumer activism.

The Breast Implant and Disease: An Observed Association or a Verdict of Causation? Part I

1996 ◽  
Vol 13 (3) ◽  
pp. 267-273
Author(s):  
Tony A. Discoe
Keyword(s):  
Causal Relationship ◽  
Breast Implant ◽  
Breast Implants ◽  
Complex Method ◽  
Legal Environment ◽  
Causal Relationships ◽  
Potential Harm ◽  
Silicone Gel ◽  
Determining Factor ◽  
Careful Thought

The issue presented in breast implant litigation, whether breast implants cause harm, graphically displays the frontiers of the interface of law and medicine, and the complex method of evaluating causal relationships in medicine. Should the law wait for an answer? This paper provides a system for evaluating the results of studies in the area of breast implant litigation, in terms of the extent to which those results support or refute a causal relationship. The concept and characteristics of causation and the reliability of cases, reports, descriptive studies, and anecdotal cases as evidence of causation are discussed. Because of the current media and medical legal environment, recommendations for the care and treatment of patients with breast implants are being made without careful thought. The consequences of widespread litigation may be the determining factor in attempting to resolve the question of the potential harm of the silicone-gel breast implant.

The Breast Implant and Disease: An Observed Association or a Verdict of Causation? Part II

1996 ◽  
Vol 13 (4) ◽  
pp. 381-387
Author(s):  
Tony A. Discoe
Keyword(s):  
Causal Relationship ◽  
Breast Implant ◽  
Breast Implants ◽  
Complex Method ◽  
Legal Environment ◽  
Causal Relationships ◽  
Potential Harm ◽  
Silicone Gel ◽  
Determining Factor ◽  
Careful Thought

The issue presented in breast implant litigation, whether breast implants cause harm, graphically displays the fron-tiers of the interface of law and medicine, and the complex method of evaluating causal relationships in medicine. Should the law wait for an answer? This paper provides a system for evaluating the results of studies in the area of breast implant litigation, in terms of the extent to which those results support or refute a causal relationship. The concept and characteristics of causation and the re-liability of cases, reports, descriptive studies, and anecdotal cases as evidence of causation are discussed. Because of the current media and medical legal environment, recommen-dations for the care and treatment of patients with breast implants are being made without careful thought. The con-sequences of widespread litigation may be the determining factor in attempting to resolve the question of the potential harm of the silicone-gel breast implant.

scholarly journals Thoracic migration of silicone gel after breast implant rupture: a case report and literature review

2021 ◽  
Author(s):  
Benedetta Fanelli ◽  
Marco Marcasciano ◽  
Stefano Lovero ◽  
Luca Codolini ◽  
Donato Casella ◽  
...  
Keyword(s):  
Breast Reconstruction ◽  
Biological Membrane ◽  
Breast Implant ◽  
Granulomatous Inflammation ◽  
Breast Implants ◽  
Silicone Implants ◽  
Axillary Lymph ◽  
Implant Rupture ◽  
Silicone Gel ◽  
Breast Implant Rupture

AbstractNowadays silicone is a widespread material for medical devices. In particular, it is commonly used for implants manufacturing, for that patients undergoing breast augmentation or breast reconstruction after mastectomy. However, the use of silicone implants is not free from risks. Ruptures of silicone breast implants are uncommon, in general post-traumatic or iatrogenic, and usually related to implant’s wall weakness of unknown origin but probably due to biochemical reactions that cause wall rupture. As a consequence of a rupture, silicone gel from damaged implants may have a continuity migration to the chest wall, axillae, and upper extremities, resulting in granulomatous inflammation or siliconoma, or a lymphatic migration to axillary lymph nodes. In this regard, silicone thoracic migration is extremely rare, and nowadays a leakage is unlikely to happen with more modern cohesive silicone gel implants. Nevertheless, procedures such as thoracic surgery and thoracotomies may be responsible for accidental breast implant rupture, capsular discontinuity, and eventually intrathoracic silicone migration, especially when dealing with older generations of breast implants. We report a rare case of a 75-year-old woman presenting with pleural silicone effusion, 18 years after a right breast reconstruction for breast cancer, followed by right upper lobe resection for a lung carcinoma. A combination of muscular flap and DTI pre-pectoral breast reconstruction with biological membrane (ADM) has been used for treatment. Literature was reviewed for cases of breast implants free silicone localization in the chest cavity, focusing on previous surgeries, anamnestic relevances, and surgical management.Level of Evidence: Level V, risk/prognostic study.

scholarly journals A Preliminary Retrospective Study to Assess the Short-Term Safety of Traditional Smooth or Microtextured Silicone Gel-Filled Breast Implants in Korea

Medicina ◽  
2021 ◽  
Vol 57 (12) ◽  
pp. 1370
Author(s):  
Sanghyuk Han ◽  
Robert Kim ◽  
Tae Seob Kim ◽  
Jung Heum Park ◽  
Seung Soo Kim ◽  
...  
Keyword(s):  
Retrospective Study ◽  
Postoperative Complications ◽  
Subgroup Analysis ◽  
Safety Profile ◽  
Breast Implant ◽  
Breast Implants ◽  
Augmentation Mammaplasty ◽  
Korean Women ◽  
Short Term ◽  
Silicone Gel

Background and objectives We conducted this preliminary retrospective study to assess the short-term safety of silicone gel-filled breast implants (SGBIs) that are commercially available in Korean women. Materials and methods The current retrospective, observational study was conducted in a total of 2612 patients (n =2612) who underwent augmentation mammaplasty using breast implants at our hospitals between 1 January, 2017 and 31 August 2021. Results Overall, there were a total of 248 cases (9.49%) of postoperative complications; these include 112 cases of early seroma, 52 cases of shape deformation, 32 cases of CC, 12 cases of early hematoma, 12 cases of rupture, 12 cases of infection, 12 cases of stretch deformities with skin excess and 4 cases of rippling. Overall complication-free survival of the breast implant was estimated at 1564.32 ± 75.52 days (95% CI 1416.39–1712.32). Then, the Motiva Ergonomix™SilkSurface showed the longest survival (1528.00 ± 157.92 days [95% CI 1218.48–1837.56]), followed by the BellaGelÒSmoothFine (1458.4 ± 65.76 days [95% CI 1329.56–1587.28]), the SebbinÒ Sublimity (1322.00 ± 51.20 days [95% CI 1221.64–1422.32]), the BellaGelÒ Smooth (1138.72 ± 161.28 days [95% CI 822.6–1454.84), the MentorÒ MemoryGel™ Xtra (698.4 ± 52.64 days [95% CI 595.28–801.52]) and the NatrelleÒ INSPIRA™ (380.00 ± 170.88 days [95% CI 45.04–714.96]) in the decreasing order. On subgroup analysis, both the Motiva ErgonomixTM and MentorÒ MemoryGel™ Xtra showed no postoperative complications. However, the BellaGelÒSmoothFine, SebbinÒ Sublimity and BellaGelÒ Smooth showed incidences of 8.87%, 4.84% and 1.61%, respectively. A subgroup analysis also showed differences in incidences of postoperative complications between microtextured and smooth breast implants (15.18% vs. 16.67%). Conclusions In conclusion, our results indicate that diverse types of an SGBI are commercially available and their safety profile varies according to the manufacturer. Plastic surgeons should consider the safety profile of each device in selecting the optimal types of the device for Korean women who are in need of an implant-based augmentation mammaplasty. However, this warrants a single-surgeon, single-center studywith long periods of follow-up.

Hydrogel-Filled Mammary Prosthesis

1998 ◽  
Vol 15 (3) ◽  
pp. 259-262
Author(s):  
Guy-Henri Muller
Keyword(s):  
Breast Implant ◽  
Breast Implants ◽  
Living Tissue ◽  
Silicone Breast Implant ◽  
Postoperative Results ◽  
Silicone Gel ◽  
Mammary Prosthesis ◽  
One Year ◽  
Visual Results ◽  
Better Than

Introduction: The silicone breast implant controversy and the moratorium on the use of silicone-gel-filled breast implants in the U.S., Canada, and France has led to a search for substitutes for silicone-gel implants that are safe, pliable, and still firm enough to hold its shape. Hydrogel is being evaluated as an alternative to silicone gel for filling breast implants. Materials and Methods: Eighteen hundred ninety hydrogel-filled breast implants were inserted into patients in France and Italy between 1992 and 1993. The postoperative results of these procedures were reviewed. Results: Twelve implant ruptures occurred at the time of insertion secondary to too small an incision and lack of prewarming of the implant. Two ruptures went unnoticed and were satisfactorily resolved with a revision of the first procedure. One capsule contracture occurred within one year. Visual results according to patients and surgeons were satisfactory. The palpable results are less favorable than silicone-gel implants, but better than saline-filled implants. Discussion: Hydrogel is biocompatible. The breakdown products of the implant filler, if they migrate outside the shell, should not be toxic. Because hydrogel is a biomaterial filler to which water is added to reach an equilibrium point, it mimics the consistency of living tissue. Conclusions: Hydrogel appears to be a favorable substitute for silicone gel.

Advances in Breast Implant Fillers

1998 ◽  
Vol 15 (3) ◽  
pp. 291-294 ◽  
Author(s):  
Melvin A. Shiffman
Keyword(s):  
Breast Implant ◽  
Breast Implants ◽  
Silicone Gel ◽  
Harmful Effects ◽  
The U.S

Introduction: The moratorium on the use of silicone-gel-filled breast implants in the U.S., Canada, and France has resulted in a flurry of research to find a mammary implant that will replace or surpass the performance of the silicone-gel breast implant and the saline breast implant. The purpose of this review is to briefly present the latest information from the literature on potential breast implant fillers currently under evaluation. Materials and Methods: The latest scientific findings on mammary augmentation implants and fillers were reviewed. Conclusions: There is still a long way to go before a satisfactory implant filler is found and is approved by the FDA. It is essential that all proposed fillers be researched carefully so that harmful effects are discovered before patients are exposed.

Breast Implant Endoscopy: Detecting Leaks in Silicone-Gel Breast Implants

AORN Journal ◽  
1994 ◽  
Vol 59 (5) ◽  
pp. 1007-1015 ◽  
Author(s):  
Janine Stone ◽  
Richard V. Dowden
Keyword(s):  
Breast Implant ◽  
Breast Implants ◽  
Silicone Gel
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