Liquid Silicone for Soft Tissue Augmentation

Duffy, David M.

doi:10.2310/6350.2005.31238

Cited by 64 publications

(56 citation statements)

References 25 publications

Supporting

Mentioning

Contrasting

Unclassified

Order By: Relevance

“…Serious adverse events and delayed reactions due to silicone injection occur usually years after treatment. Inflammatory responses with foreign body cells, massive skin necrosis, or granulomatous rosacea-like eruptions were reported [28]. Due to reorganizations of facial tissue and an increasing loss of subcutaneous fat, demarcation of implanted silicone is possible during the aging process.…”

Section: Adverse Events Related To Permanent Fillersmentioning

confidence: 99%

“…Solid silicone is used as implanted prosthetic devices, but as injectable dermal filler the liquid form, silicone oil or gel, is used [15,27]. The FDA approved two forms of liquid silicone for retinal tamponade, namely AdatoSil (Bausch & Lomb) and Silikon 1000 (Alcon Labs) [28]. Even though the FDA did not approve these liquid silicones for injection to fill wrinkles or augment tissues in the body [29], there is tremendous off-label use.…”

Section: Permanent Fillersmentioning

confidence: 99%

See 1 more Smart Citation

Critical Appraisal of the Safety of Dermal Fillers: A Primer for Clinicians

Luebberding

Alexiades-Armenakas

2013

Curr Derm Rep

View full text Add to dashboard Cite

Injectable cosmetic wrinkle fillers are soft-tissue fillers approved as medical devices by the U.S. Food and Drug Administration (FDA). These devices are injected into the skin for correcting soft-tissue contour defects, such as moderate and severe wrinkles and folds, and for restoring the signs of facial fat loss in people with human immunodeficiency virus. Although the aesthetic treatment with injectable dermal fillers is considered to be safe, adverse events are involved with this minimally-invasive treatment. The FDA received 930 post-marked reports of adverse event from 2003 through 2008, of which 823 were deemed severe and 638 required medical treatment and follow-up.

show abstract

Section: Adverse Events Related To Permanent Fillersmentioning

confidence: 99%

Section: Permanent Fillersmentioning

confidence: 99%

Critical Appraisal of the Safety of Dermal Fillers: A Primer for Clinicians

Luebberding

Alexiades-Armenakas

2013

Curr Derm Rep

View full text Add to dashboard Cite

show abstract

“…Only one relatively small prospective pilot study in which a silicone filler is used, with just six months follow-up, is available [45]. Descriptions of unpublished FDA approved studies for silicone fillers [10,46] are insufficiently detailed to draw conclusions. For the more recent filler materials such as polymethyl methacrylate micro spheres in collagen, polyethyl methacrylate (copolymer of hydroxyethylmethacrylate and ethylmethacrylate) in hyaluronic acid, polyacrylamid solution, polyalkylimide solution, more data from prospective studies are available, with varying sizes of the study populations and follow-up periods for each product (TABLE 4).…”

Section: Permanent Tissue Fillersmentioning

confidence: 99%

“…Estimates of the occurrence of severe complications after treatment with various types of injectable tissue fillers range between 1:80 and 1:50,000 patients [9,10]. Adverse side effects can be caused by incorrect injection techniques (treatment related) or by the characteristics of the products (product related) [11,12].…”

mentioning

confidence: 99%

Clinical data on injectable tissue fillers: a review

Vries

Geertsma

2013

Expert Review of Medical Devices

View full text Add to dashboard Cite

Treatment with injectable tissue fillers for aesthetic purposes is increasingly popular. In parallel with this success, questions related to the safety of these treatments and the products involved are being raised more prominently. To gain insight in the safety aspects of injectable tissue fillers, we performed a literature review to collect studies reporting clinical data of injectable tissue fillers. We found several case reports where serious complications after more than three years are described. However, there are only a limited number of well-defined prospective clinical studies available with follow-up periods longer than three years. Furthermore, causes of complications, that is, treatment or product related, are often not specified in literature. Considering the intended functional period of fillers in combination with the known occurrence of long-term complications, there is a need for well-defined prospective clinical studies. In order to be able to discriminate between product failure (a product safety issue) or application methodology (a physician expertise or training issue), better identification of observed complications and whether they are product or treatment related, is needed. For the safe use of the fillers it is important that treatment with injectable tissue fillers is performed by a trained physician, who knows the product specifications and its applications. . Moreover, it is expected that due to increase in life expectancy, the demand for anti-aging treatments, like tissue augmentation with injectable tissue fillers, will grow [2]. Their success has been attributed to the fact that treatments with injectable tissue fillers are fast and appear to be relatively easy [2]. Only a relatively 'simple' subcutaneous injection is needed. Today, various injectable tissue fillers with different characteristics are available, for example, duration of the effect, material type and intended anatomical location.Although the application of an injectable tissue filler seems to be relatively simple and safe, reports of serious adverse effects have appeared in the literature [2][3][4][5][6][7][8]. Estimates of the occurrence of severe complications after treatment with various types of injectable tissue fillers range between 1:80 and 1:50,000 patients [9,10]. Adverse side effects can be caused by incorrect injection techniques (treatment related) or by the characteristics of the products (product related) [11,12]. Short-, mid-and long-term complications can be discerned (TABLE 1) [2,13-15]. Short-term complications like pain, swelling, fever, immediate hypersensitivity reactions, occur immediately or within several days past treatment and disappear after several weeks. A more severe short-term complication is necrosis [5,16]. Necrosis occurs immediately or within a few days if blood vessels are obstructed by the filler material or if they are injured during the treatment [17]. Mid-term complications such as delayed inflammatory reactions, ulceration and granuloma reaction may occur after 2-12 months. I...

show abstract

“…LIS is controversial, with both advocates and opponents citing anecdotal data to support their position (Orentreich and Jones 2005 ;Jones et al 2004 ;Barnett and Barnett 2005 ;Balkin 2005 ;Duffy 2005 ;Rapaport 2002 ). Advocates of LIS rely on a wealth of anecdotal data to assert that it is safe and effective if the following three rules are strictly followed: Rule 1 : Inject only pure medical grade, highly purifi ed LIS that is intended for injection into the human body and specifi cally FDA approved for that purpose.…”

mentioning

confidence: 99%

Liquid Injectable Silicone for the Upper Third of the Face

Jones

2014

Pearls and Pitfalls in Cosmetic Oculoplastic Surgery

View full text Add to dashboard Cite

Liquid Silicone for Soft Tissue Augmentation

Cited by 64 publications

References 25 publications

Critical Appraisal of the Safety of Dermal Fillers: A Primer for Clinicians

Critical Appraisal of the Safety of Dermal Fillers: A Primer for Clinicians

Clinical data on injectable tissue fillers: a review

Liquid Injectable Silicone for the Upper Third of the Face

Contact Info

Product

Resources

About