Comparison of the Capsular Response to the Biocell RTV and Mentor 1600 Siltex Breast Implant Surface Texturing: A Scanning Electron Microscopic Study

Danino, A.; Basmacioglu, Philippe; Saito, Seiko; Rocher, François; Blanchet-Bardon, C; Revol, M.; Servant, J.-M.

doi:10.1097/00006534-200112000-00032

Cited by 103 publications

(64 citation statements)

References 29 publications

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“…The direct contact with the Biocell textured surface, supported by the firmness of the highly cohesive gel, and its engagement with a surgically created vascular host pocket frequently allows for tissue adherence and immobility with softness. 8,19 These findings, first established with Biocell tissue expanders, are more likely to occur with the 410 implant than with less cohesive, round, textured implants in a less precise surgical pocket. Furthermore, the reduced rate of capsular contracture with the Natrelle 410 implant and the clinically appreciated softness has been described as providing a one breast feel as compared with a round implant moving in its larger pocket separate from the movement of the overlying breast and soft tissue.…”

Section: Discussionmentioning

confidence: 97%

Ten-year results from the natrelle® 410 anatomical form stable silicone breast implant core study

Maxwell

Natta

Bengtson

et al. 2014

Journal of Plastic, Reconstructive & Aesthetic Surgery

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Background: Silicone breast implants have long been used for breast augmentation and reconstruction. During this time, these medical devices have gone through a number of modifications to improve their safety, quality, and clinical outcome performance. Objectives: The authors conducted a 10-year study to determine the safety and effectiveness of Natrelle 410 silicone breast implants. Methods: This prospective, multicenter study enrolled 941 subjects who were undergoing either augmentation, augmentation revision, reconstruction, or reconstruction revision. Data on complications, reoperations, explantations, and subject satisfaction were collected at annual clinic visits, and one-third of subjects underwent biennial magnetic resonance imaging (MRI) to screen for implant rupture. The authors used the Kaplan-Meier estimator to calculate risk rates for local complications, reoperations, and explantations. Results: Capsular contracture rates increased approximately 1% per year from the previously reported 6-year rates. The rates were significantly lower than those from the Natrelle round gel core study. The overall rate of confirmed ruptured implants in subjects who underwent MRI was 5.7%. Eleven late seromas were reported. The most common reason for explantation was a subject requesting a size or style change. Satisfaction rates remained high through 10 years, with most subjects saying they were somewhat or definitely satisfied with their implants. Conclusions: This 10-year prospective trial demonstrated the long-term safety and effectiveness of Natrelle 410 anatomical form-stable implants. The complication rates were low and the satisfaction rates were high.

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Section: Discussionmentioning

confidence: 97%

Ten-year results from the natrelle® 410 anatomical form stable silicone breast implant core study

Maxwell

Natta

Bengtson

et al. 2014

Journal of Plastic, Reconstructive & Aesthetic Surgery

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“…One of the critical issues during the evolution of the texture is to find a way to stabilize the implant in the breast pocket. Studies have demonstrated that the pore size is critical to allow for tissue adherence leading to the "adhesive effect" and implant stabilization (33). However, it was not clear if the pore size correlated with a reduction in capsular contracture, but did correlate with implant stabilization (33).…”

Section: Surfacementioning

confidence: 99%

“…Danino et al compared the BioCell texture with pore diameter of 600-800 μm with a depth of 150-200 μm to Siltex pore diameter of 70-150 μm. It was noted that Siltex pores lead to no "adhesive effect" (33).…”

Section: Surfacementioning

confidence: 99%

Breast implant design

Maxwell¹,

Gabriel²

2017

Gland Surg.

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“…The Biocell surface is an aggressive, open-pore, textured surface, created with a lost-salt technique (28). The elastomeric shell is placed on a bed of finely graded salt, and light pressure is applied to increase the depth of the depressions.…”

Section: Chronic Inflammationmentioning

confidence: 99%

Late unilateral breast enlargement after insertion of silicone gel implants: A histopathological study

Peters¹,

Fornasier²

2007

CAN J PLAST SURG

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Late unilateral breast enlargement after the insertion of silicone gel breast implants is a very rare phenomenon. The present study reports five women who presented with this finding over the past 20 years. Three of these patients presented with late unilateral hematomas, which developed nine, 12 and 14 years, respectively, after initial breast augmentation, in the absence of any known trauma. These patients presented for treatment one, four and 12 months, respectively, after their breast enlargements initially appeared. Two of these patients had developed chronic expanding hematomas. Extensive histopathological analyses of the capsules of all three patients provided explanations for the etiologies and progressions of the findings in these patients. In each of the three patients, the etiology of the hematoma was consistent with erosion of a capsular artery. Numerous large vessels were seen within the wall of the capsules. In each case, there was a class IV capsular contracture, which could have increased the friction of the intact implant against the capsule, and there was both old (hemosiderin deposits) and new bleeding into the pocket from the capsules. This supports the concept that numerous episodes of bleeding had occurred in each case. Histopathology also demonstrated the progression of the hematomas. After four weeks, only liquefied hematoma was present, while after four months, there were both liquefied hematoma and blood clotting. The hematoma on the surface of the capsule was becoming organized peripherally, but not centrally. After 12 months, the hematoma was becoming very well organized compared with the hematoma at four months. In one of the two remaining cases, late infection was the cause of the breast enlargement. Histopathology of this capsule showed that the involved capsule was six times as thick as the other side. It also showed edema and infiltration by scattered mononuclear cells, polymorphonuclear cells, and irregular crenated and degenerating nuclei. In the final patient, chronic inflammation appeared to be the cause of the breast enlargement. The histopathology of this capsule was unique. Its inner surface showed re-epithelialization and metaplasia of the ductal epithelium to form stratified squamous epithelium with early surface keratinization. These findings are consistent with synovial metaplasia. Several areas of the fibrous portion of the capsule showed patchy loss of cellular staining with loss of nuclei, indicative of necrosis. This produced a 'washed out' staining appearance. This tissue was paucivascular and fibrotic, and showed areas of fibrinoid necrosis, suggestive of mechanical abrasion and increased pressure.Key Words: Enlargement; Silicone gel breast implants Hypertrophie mammaire unilatérale tardive après la pose d'une prothèse de silicone : examen histopathologique L'hypertrophie mammaire unilatérale tardive après la pose d'une prothèse de silicone est rarissime. Le présent rapport fait état de cinq femmes qui ont connu ce type de complication au cours des 20 dernières a...

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Comparison of the Capsular Response to the Biocell RTV and Mentor 1600 Siltex Breast Implant Surface Texturing: A Scanning Electron Microscopic Study

Cited by 103 publications

References 29 publications

Ten-year results from the natrelle® 410 anatomical form stable silicone breast implant core study

Ten-year results from the natrelle® 410 anatomical form stable silicone breast implant core study

Breast implant design

Late unilateral breast enlargement after insertion of silicone gel implants: A histopathological study

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