The history of Trilucent implants, and a chemical analysis of the triglyceride filler in 51 consecutively removed Trilucent breast prostheses

Kirkpatrick, W.N.A.; Jones, Barry M.

doi:10.1054/bjps.2002.3903

Cited by 21 publications

(11 citation statements)

References 20 publications

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“…All of the implants in our study 22 showed evidence of shell deterioration, suggestive of lipid absorption. Some of the silicone elastomer shells had deteriorated to such an extent that they ruptured with minimal handling, and could be torn easily following explantation (Fig.…”

Section: Further Scientific Assessment Of Risksmentioning

confidence: 54%

The Trilucent breast implant experience

Kirkpatrick¹,

Jones²

2003

Clinical Risk

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we began a series of articles on breast reconstruction. Christopher Ward discussed his experience of 105 claimants between 1990 and 1999, all of whom were dissatisfied with the results of plastic surgery to the breast. He addressed the generic question 'why do patients sue?' Recently, there has been widespread public concern about prosthetic devices used as implants in breast augmentation. Paul Balen CLINICAL RISK (2003) 9, 1-9

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Section: Further Scientific Assessment Of Risksmentioning

confidence: 54%

The Trilucent breast implant experience

Kirkpatrick¹,

Jones²

2003

Clinical Risk

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“…In particular, we always found that the inferior central part of the shell was strongly attached to the chest wall, causing rupture when gently trying to dissect it off; this observation is confirmed by other reports. 26,27 This could be from either an intrinsic weakness from the manufacturing process or premature aging. Although there are no specific data published regarding the premature aging of the Trilucent implant shell, the latter hypothesis is supported by Adams et al, 28 who speculated that lipids infiltrate the outer shell of the silicone elastomer and that this may be the cause of the progressive mechanical weakening.…”

Section: Resultsmentioning

confidence: 99%

“…Although this fluid did not show any bacterial growth, as shown in our series and in other studies, 14,29 recent reports demonstrated evidence of in vivo Trilucent implant shell deterioration and lipid bleed throughout the implant shell. 26,30 Lipid peroxidation into aldehyde byproducts seems to occur, yielding to genotoxic concentrations. 26 Trilucent implants seem not able to give rise to a systemic immune response in vivo.…”

Section: Resultsmentioning

confidence: 99%

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Trilucent Breast Implants: Voluntary Removal following the Medical Device Agency Recommendation. Report on 115 Consecutive Patients

Gherardini

Zaccheddu

Basoccu

2004

Plastic and Reconstructive Surgery

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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.

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“…A Swedish study that examined 106 women, who had been implanted with 109 prostheses reports that after 11 years the percentage of breakage was about 8%. Analogously with such results, a Danish study monitored and analysed 533 prosthetic mammary implants, between 1973 and 1997, reports that after 16-20 years from implantation, the percentage of malfunctioning prostheses is around 26% [27][28][29][30]. Recently, on the professionalism are not exercised.…”

Section: Journal Of Chemical Engineering and Process Technologymentioning

confidence: 89%

The Use of Medical Devices in Italy and Europe: Between Legal Obligations, Operational Obstacles and Possible Responsibilities

Vacchiano¹

2015

J Chem Eng Process Technol

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The use of medical devices is in continuous expansion and constitutes a valid aid to ailing people, due to remarkable technological advances. The regulation on their circulation in Italy and Europe are inspired by the principle of free circulation. In fact it is sufficient for a device to have the CE logo for it to be freely commercialized in all of Europe.This way of operating that favors commerce, exposes the sick to the risk of harm from defective devices that have not been suitably checked prior to their commercialization.Having discussed a few episodes characterized by device malfunctioning, the author observes the need for a more rigorous control policy for devices, adequate care on the part of doctors who use such tools, and of suitable insurance measures for the patient in the event of harm.

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The history of Trilucent implants, and a chemical analysis of the triglyceride filler in 51 consecutively removed Trilucent breast prostheses

Cited by 21 publications

References 20 publications

The Trilucent breast implant experience

The Trilucent breast implant experience

Trilucent Breast Implants: Voluntary Removal following the Medical Device Agency Recommendation. Report on 115 Consecutive Patients

The Use of Medical Devices in Italy and Europe: Between Legal Obligations, Operational Obstacles and Possible Responsibilities

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