[Breast implants and silicone: silicone crisis' history]. / Implants mammaires et silicone: histoire d'une crise.

In 1992 the FDA declared a moratorium on silicone implants, after a fight with the manufacturers. This moratorium extended world wide and lasted differently among the different countries. In Europe, France was the most troublesome about this problem. It took 8 years of actions against several civil servants and at least a trial at the "Council of State" could succeed in 2000 and brough back the silicone implants to the market in 2001.

[40 years of silicone breast implants]. / Silikonbrystimplantater gjennom 40 år.

BACKGROUND: It is estimated that approximately 50,000 Norwegian women have silicone breast implants following breast augmentation or breast reconstruction. Their numbers are growing and doctors will more often be confronted with the health problems related to these implants. MATERIAL AND METHODS: This review is based on information retrieved from Medline and our clinical experience. RESULTS AND INTERPRETATION: The modern silicone breast implant is the product of four decades of development. The ongoing debate on health problems associated with the implants has been a vibrant stimulator for research, but a causal relationship between implants and the development of breast cancer and autoimmune defects has not been found. The implants are not, however, without complications; more research is required in order to improve the implants and for quality assurance of treatment and follow up.

Augmentation mammaplasty: the story before the silicone bag prosthesis.

Czerny from Heidelberg is generally accepted to have performed the first augmentation mammaplasty in 1895. Since then, a variety of nonsilicone materials have been injected or implanted to augment or to reconstruct the hypoplastic female breast, including autologous tissues, intramammary- or submammary-injected alloplastic materials, and preformed alloplastic materials other than silicone. For various reasons outlined in this review, none was fully acceptable. The introduction of the medical-grade silicone bag prosthesis in the early 1960s improved the results of mammary augmentation dramatically and reduced the incidence of fibrous contracture and implant extrusion. Other methods of breast augmentation became obsolete.

Refining the qualification process for medical materials.

This article examines the history of the use of silicone elastomers in medical devices and explains the importance of understanding a material's physical and chemical properties. Related issues of biocompatibility testing, materials biodurability, process controls, regulation, cost, FDA master files, and expedited approval also are addressed.

Biomaterials in foot surgery.

Implants have become an important part of the foot surgeon's armamentarium. They have facilitated or improved the results in many reconstructive procedures. Understanding the concepts, applications, and characteristics of the various implants and biomaterials is important to providing maximal benefits to patients.

History of implants.

In summary, implants are highly successful because encapsulation occurs around the implant without rejection and no other fixation is necessary. There is relatively no shortening or instability of the toe, such as a floppy toe. This seems to prevent painful stiff pseudoarthrosis or arthritis because it acts as a spacer to prevent narrowing of the joint and allows for movement. It prevents a short first toe and prevents any undesired cosmetic results, as it provides the joint with a pain-free range of motion, allowing it to become more mobile and stable. Also, ulnar implants have been used with the same indications and contraindications. The most important consideration about implant surgery is that these implants, that is, the Silastic and the Swanson design, are nonabsorbable. They will not cause tissue reaction and the fibrous encapsulation forms all that is necessary to encapsulate the implant itself; therefore, there is very little bony rejection. From recent literature and through professional experience, it has been proved that implants act primarily as a spacer. They provide a pain-free range of motion but not as well as desired. Implants provide stability to the joint, which is of the utmost importance. The Silastic implants have stood the test of time in most cases. However, the search for better biomaterials, better results, and better functions is never ending. There is a great need for continued research into this field. Podiatry must continue to maintain, contribute, and improve this research.