FDA requires dermal filler products to label risk tips

In view of the strong reaction of the medical profession and consumers to the abuse of skin and soft tissue fillers in the plastic surgery industry, the US Food and Drug Administration (FDA) introduced several large companies that produce and sell skin and soft tissue filler materials in the United States at the end of May. (including the silicone manufacturers of implants NestleSA and Actavis, etc.) issued a warning letter asking these manufacturers to immediately change the contents of their product manuals, and indicate the prompt information in the eye-catching position of the product packaging, such as "use of this product will increase accidental injury. The possibility, etc., to alert consumers to the potential risks of using skin and soft tissue fillers. This is the most serious warning letter issued by the FDA in recent years for skin and soft tissue fillers.

Not only that, the FDA also requires the manufacturers of skin and soft tissue fillers to add "in the product manual" to the warning letter. "The use of this product may have the following consequences: such as vascular occlusion, blockage of blood flow to tissues, impaired vision or Blindness, ischemic stroke, skin (local) damage or necrosis, facial muscle stiffness (mask face) and subcutaneous tissue death, etc. According to the FDA, the above risks are all from medical device adverse event reports submitted by US doctors.

The rapid development of the global plastic surgery industry has led to a rapid growth in the market for skin and soft tissue fillers. In recent years, silicone or silicone, hyaluronic acid (glass acid) skin and soft tissue fillers have been very popular in countries around the world, and they are mainly used for breast augmentation, rhinoplasty, (facial) wrinkle removal and other cosmetic uses. The FDA stipulates that skin and soft tissue fillers are Medical Devices. In addition, Botox (BOTOX) for facial wrinkles is also managed as a medical device in the United States. However, while the use of skin and soft tissue fillers has grown rapidly, the resulting medical device adverse events have emerged. According to media reports, many breast augmentation women have caused great consequences for implants due to rupture, displacement and leakage of silicone or silicone implants to other parts of the body, leading to inflammation, pus formation and even obstruction of blood vessels. Physical and mental injury.