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French health authorities have informed manufacturers of a sweeping and historic ban on two categories of breast implants that are associated with an elevated risk of a rare form of cancer. The prohibitionsparked by concerns of higher associated cancer risks, covers macro-textured and polyurethane implants. It marks the most significant restriction that health authorities have imposed on breast implants during a wave of regulatory actions in recent months.
France on Thursday became the first country to ban a type of breast implant that has been linked to a rare form of cancer. The ban covers certain types of implants with a textured surface or polyurethane coating. The National Agency for Medicines and Health Products ANSM said the ban was a "precautionary measure" taken in light of the "rare but serious danger" posed by the implants, which have been linked to anaplastic large-cell lymphoma BIA- ALCLa rare type of cancer that attacks the immune system.
According to the FDA, about million women worldwide have breast implants. This market is growing at a relatively slow pace in developing countries. However, the market in Asia is expected to witness an increase in its market shares. View the Latest Market Research.
Multicenter prospective studies assessing the safety and efficacy of silicone gel breast implants are relatively rare. Eurosilicone S. Physical examinations and complications were recorded by physicians at 3 months and annually thereafter until 10 years postimplantation.
A type of breast implant used by millions of women around the world is under scrutiny after French surgeons were advised to stop using it because of a potential link with a rare kind of cancer. Textured breast implants have been linked with anaplastic large cell lymphoma ALCLwhich forms in the scar capsule around the implant and normally begins with pain and swelling in the breast. Women who have the implants and capsules removed can make a full recovery, but if left untreated the disease can spread throughout the body and become life-threatening.
As of Thursday, specific types of breast implants — namely those with a textured or polyurethane coating — are no longer allowed in France. The ban of these implants are due to concerns that they have the potential to cause a type of cancer called anaplastic large cell lymphoma BIA-ALCL. In finalizing the ban, France has become the first country ever to do so.
Background: The safety and efficacy of all medical devices, including breast implants, is important and consistent performance is best shown by undertaking long-term clinical and vigilance studies. Local complications such as capsular contracture and rupture are risks often associated with breast implant surgery. Objectives: The authors investigate and evaluate the safety and performance of Eurosilicone's Eurosilicone S. Methods: In this prospective clinical study, Eurosilicone textured cohesive Cristalline Paragel mammary implants were implanted in women undergoing augmentation and reconstructive surgery at 17 centers across France.
Eurosilicone breast implants are implants made by a company specializing in the production of silicone breast implants as well as silicone implants used to enhance chins, calves and glutes. Eurosilicone is based in France. Its breast implants have an excellent safety profile and are fully compliant with European standards.
Two keywords that crop up when talking about implants nowadays are safe and natural. Thus, there has been a lot of testing on the surface layer with both smooth and coarse surfaces being popular at different times. Smooth implants are safer. Coarse implants attach readily to tissue, minimizing the risk of slipping, but also have a higher risk of capsular contracture.