Release date: 2006-11-21
Silicone materials "returning out of the rivers and lakes" can not guarantee a lifetime of worry Many women dream of changing their face through breast augmentation surgery, but the safety and risk of surgery is the biggest concern. On November 17, the US Food and Drug Administration (FDA) lifted the 14-year ban on silicone breast implant materials, allowing the two companies to produce products. This has caused a great shock in the American medical community and will bring about a re-segmentation of the plastic surgery market.
Silicone material "returns to the rivers and lakes"
According to CNN, the sales licenses are Aleksand and Mentor of California. The silicone materials produced by the two companies are allowed for breast reconstruction surgery for women of all ages and for breast augmentation surgery for women over 22 years of age.
The FDA said in a statement that two companies in California have followed up on women who have undergone clinical trials of silicone breast augmentation surgery over the past 10 years and have submitted detailed clinical and incubation study data. An advisory committee composed of outside experts and an independent research institute conducted a cautious review. After consulting a large amount of data, the FDA approved their application for lifting the ban.
Daniel Schultz, FDA's director of medical equipment, said: "The safety and effectiveness of Allergen and Mentor's breast implant products are reasonably assured, and women can make decisions with sufficient information."
Can't guarantee a lifetime of worry
However, this "reasonable security" is also limited. The FDA cautioned that the clinical trial data of the two companies showed that after the silicone material was implanted into the breast, abnormalities such as hardening or even rupture of the transplant site and breast pain may occur. Moreover, silicone materials are not guaranteed to be effective for a lifetime, and a second surgery may be required.
Therefore, the FDA also requested the two companies, including the details of the advantages and disadvantages of using this material on the label of the silicone material, reminding consumers to regularly receive MRI scans of the breast after implanting the silicone material, in case The filler ruptured. After the product was officially launched, the two companies also conducted a 10-year follow-up study of 40,000 women to record possible side effects.
The FDA's decision has sparked controversy in the US medical community and public health groups. Many researchers suspect that the implantation of silicone material into the breast may lead to connective tissue disease and even cancer in women's breasts.
Market redistribution
Silicone materials began to be used for female breast augmentation or breast reconstruction in 1962. Later, due to safety issues, the FDA banned its marketing in 1992 and was limited to certain medical research. In the United States, 291,000 women underwent breast augmentation surgery in 2005, and another 58,000 received breast reconstruction. Only 10%-15% used silicone products, and the rest used saline bags.
There is no similar ban in Europe and China, and silica gel materials with better market response have been the mainstream products in the breast augmentation market. The FDA's lifting of the ban will lead to a reshuffle of the US breast augmentation industry market, and the share of silicone materials and salt water bags may gradually reverse.
—— Information from: China Medical Device Industry Association
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