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1.
Ann Chir Plast Esthet ; 65(1): 1-6, 2020 Feb.
Article in French | MEDLINE | ID: mdl-31331682

ABSTRACT

Since the dawn of breast implantation back in the sixties, five generations of breast implants have tried to provide the most natural-looking results while striving to eliminate the risk of unpleasant ruptures or capsular contractures. National Health regulators (i.e. the FDA in USA and ANSM in France) have had an "after the facts" reaction, which led to a so-called "dirty war" among producers in the form of a 1992 Silicone's Moratorium (after suspicions of associated cancer or immune-related disorders) all this under the rigid oversight of a FDA director, who seemed more sensible to media scandal than scientific data. After more than a decade of consistent scientific evidence, the interdiction was finally ended in France in 2001 and in the USA in 2006, however the scandals resurfaced again in 2011 after a proven fraud on the "PIP - affair" and most recently with "breast implant associated - anaplastic large cell lymphoma", an extremely serious and rare pathology, treated only by surgical means, until further research. We describe also a chronology on the way the FDA finally recognized this dramatic complication.


Subject(s)
Breast Implants/history , Breast Neoplasms/chemically induced , Breast Neoplasms/history , Lymphoma, Large-Cell, Anaplastic/chemically induced , Lymphoma, Large-Cell, Anaplastic/history , Silicones/history , Breast Implants/adverse effects , Female , France , Fraud/history , History, 20th Century , History, 21st Century , Humans , Risk Factors , Silicones/adverse effects , United States , United States Food and Drug Administration/history
2.
Prensa méd. argent ; 99(1): 49-54, mar. 2013. ilus
Article in Spanish | BINACIS | ID: bin-130044

ABSTRACT

Nuestra Unidad recibe por su área programática de influencia, pacientes de bajos recursos socioeconómicos y culturales que fueron sometidos a prácticas ilegales de inclusión de materiales de uso no médico por vía infiltrativa en las mamas y que requirieron trtamiento quirúrgico como consecuencia de haber causado procesos inflamatorios inespecíficos con deformidad y dolor invalidante. En el período comprendido entre el 26/10/2009 al 26/10/2010 en la Unidad de Cirugía Plástica del HZGA Dr. Lucio A. Meléndez de Adrogué tres pacients intervenidos quirúrgicamente por presentar siliconomas mamarios. El procedimiento de elección fue adenomastectomia subcutánea bilateral con reconstrucción posterior con implantes, con buenos resultados estéticos. El desconocimiento y las consecuencias por la aplicación infiltrativa de siliconas industriales en las mamas obligan al equipo de cirugía plástica a desarrollar nuevas tácticas para solucionr las consecuencias devastadoras que las mismas producen en los pacientes(AU)


Our Unit received for its program area of influence, patients with low socioeconomic and cultural resources that were subjected to illegal practices including non-medical use materials via infiltration in the breast and needed surgery as a consequence of nonspecific inflammatory processes caused by deformity and crippling pain. In the period from 26/10/2009 to 26/10/2010 in the Unit of Plastic Surgery Dr. Lucio A. HZGA Melendez Adrogué three patients undergoing surgery for breast siliconomas present. The election procedure was adenomastecty reconstruction after bilateral subcutaneous implants, with good aesthetic results. The ignorance and the consequences for the application infiltrative industrial silicone breast forces the plastic surgery team to develop new tactics to adress the devstating consequences that they produce in patients(AU)


Subject(s)
Female , Silicones/adverse effects , Silicones/history , Mammaplasty/adverse effects , Mammaplasty/history , Mastitis/diagnosis , Mastitis/surgery , Mastitis/diagnostic imaging , Mastectomy, Subcutaneous , Breast Implants
3.
Prensa méd. argent ; 99(1): 49-54, mar. 2013. ilus
Article in Spanish | LILACS | ID: lil-719879

ABSTRACT

Nuestra Unidad recibe por su área programática de influencia, pacientes de bajos recursos socioeconómicos y culturales que fueron sometidos a prácticas ilegales de inclusión de materiales de uso no médico por vía infiltrativa en las mamas y que requirieron trtamiento quirúrgico como consecuencia de haber causado procesos inflamatorios inespecíficos con deformidad y dolor invalidante. En el período comprendido entre el 26/10/2009 al 26/10/2010 en la Unidad de Cirugía Plástica del HZGA Dr. Lucio A. Meléndez de Adrogué tres pacients intervenidos quirúrgicamente por presentar siliconomas mamarios. El procedimiento de elección fue adenomastectomia subcutánea bilateral con reconstrucción posterior con implantes, con buenos resultados estéticos. El desconocimiento y las consecuencias por la aplicación infiltrativa de siliconas industriales en las mamas obligan al equipo de cirugía plástica a desarrollar nuevas tácticas para solucionr las consecuencias devastadoras que las mismas producen en los pacientes


Our Unit received for its program area of influence, patients with low socioeconomic and cultural resources that were subjected to illegal practices including non-medical use materials via infiltration in the breast and needed surgery as a consequence of nonspecific inflammatory processes caused by deformity and crippling pain. In the period from 26/10/2009 to 26/10/2010 in the Unit of Plastic Surgery Dr. Lucio A. HZGA Melendez Adrogué three patients undergoing surgery for breast siliconomas present. The election procedure was adenomastecty reconstruction after bilateral subcutaneous implants, with good aesthetic results. The ignorance and the consequences for the application infiltrative industrial silicone breast forces the plastic surgery team to develop new tactics to adress the devstating consequences that they produce in patients


Subject(s)
Female , Breast Implants , Mastectomy, Subcutaneous , Mammaplasty/adverse effects , Mammaplasty/history , Mastitis/surgery , Mastitis/diagnosis , Mastitis , Silicones/adverse effects , Silicones/history
5.
Facial Plast Surg ; 25(2): 67-72, 2009 May.
Article in English | MEDLINE | ID: mdl-19415573

ABSTRACT

In an attempt to maintain a youthful appearance or to reconstruct facial deformities, physicians have greeted new technologies with excitement. In the late 1800 s, shortly after the invention of the syringe, chemical agents were used for facial augmentation. Unfortunately, history has taught us that new technologies must be used with care, because complications can occur, sometimes many years after initial treatment. The first injectable filling agent was paraffin, whose use was abandoned after complications of migration, embolization, and granuloma formation were described. More recently, silicone use was banned by the U.S. Food and Drug Administration (FDA) because of similar complications. In 1981, bovine collagen was the first agent to be approved by the FDA for cosmetic injection. Since its approval, dozens of injectable filling agents have been developed, and many are already FDA approved for cosmetic use. This article will review the highlights of the evolution of facial filling agents.


Subject(s)
Biocompatible Materials/history , Cosmetic Techniques/history , Adipocytes , Biocompatible Materials/administration & dosage , Collagen/administration & dosage , Collagen/history , Drug Approval/history , Europe , Face , History, 19th Century , History, 20th Century , History, 21st Century , Hyaluronic Acid/administration & dosage , Hyaluronic Acid/history , Injections, Subcutaneous/history , Korea , Paraffin/administration & dosage , Paraffin/history , Rejuvenation , Silicones/administration & dosage , Silicones/history , Syringes/history , United States , United States Food and Drug Administration/history
7.
Dermatol Surg ; 31(11 Pt 2): 1555-9; discussion 1560, 2005 Nov.
Article in English | MEDLINE | ID: mdl-16416638

ABSTRACT

BACKGROUND: Since 1964, the author has investigated injectable liquid silicone as a soft tissue substitute for the loss of plantar fat. This form of fatty tissue depletion over the sole is closely linked to a common painful weight-bearing foot disorder, metatarsalgia, and to painless diabetic foot ulcers. OBJECTIVES: To present the history of injectable silicone, corporate interest, individuals who helped pursue approval, its misuses, and events that have delayed its availability. MATERIALS AND METHODS: Dow Corning Corporation's 360 Medical Fluid of 350 centistoke was injected beneath corns and calluses in 1585 patients. Diabetic neuropathic foot ulcers were injected after healing in an effort to prevent their recurrence. Surgical and postmortem specimens were gathered for histologic analysis. RESULTS: There was no evidence of significant adverse response in long-term clinical follow-up. Silicone specimens studied by two departments of pathology found no inflammation, infection, allergy, or granulomas. CONCLUSIONS: Medical Fluid silicone appears to be safe, effective, and stable biomaterial for treating weight-bearing loss of plantar fat. Trademarked PodiSil (Richard-James Inc., Peabody, MA, USA), a 350-centistoke injectable silicone has been approved for marketing in Europe for the prevention of diabetic foot ulcers.


Subject(s)
Callosities/therapy , Diabetic Foot/therapy , Foot Diseases/therapy , Metatarsalgia/therapy , Silicones/history , History, 20th Century , History, 21st Century , Humans
8.
ASAIO J ; 46(4): 379-82; discussion 378, 2000.
Article in English | MEDLINE | ID: mdl-10926131
10.
Aesthetic Plast Surg ; 9(2): 133-40, 1985.
Article in English | MEDLINE | ID: mdl-3895848

ABSTRACT

The authors discuss the history and use of injections of paraffin, silicone, and collagen for soft-tissue contouring. The structure and uses of collagen are described with particular reference to Zyderm Collagen Implant, a highly purified bovine collagen.


Subject(s)
Biocompatible Materials/history , Collagen , Animals , Biocompatible Materials/administration & dosage , Cattle , Collagen/administration & dosage , Collagen/biosynthesis , Collagen/metabolism , Female , History, 19th Century , History, 20th Century , Humans , Injections , Male , Paraffin/administration & dosage , Paraffin/history , Rabbits , Rats , Silicones/administration & dosage , Silicones/history
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