Diyee Boulangger - Comment

In my opinion I think that the device should be classified as proposed by the FDA (class II), simply because the tissue expanders needs to have special control even though it may be a common practice use by surgeons for reconstructive surgeries. By classifying the tissue expander as class II, it gives and provides the surgeons and patients with an excellent knowledge of the possible risks. Even though, tissue expansions may be a common practice, it still contains risks that need to be addressed. Tissue expansions can match color, texture, and hair-bearing qualities. Second, because the skin remains connected to the donor area's blood and nerve supply, there is a smaller risk that it will die. In addition, because the skin doesn't have to be moved from one area to another, scars are often less apparent. However, the length of time required to grow additional skin can be between three or four months. During this time, the tissue expander can be an unsightly bulge which can be quite noticeable for someone requiring repair of the scalp or other parts of the body. If FDA approves the classification II of this surgical device, patients will be aware that silicone expander, for example, can break or leak while it is in the body. Expanders are rigorously tested and placed with care, leaks do occur. This is why it is important to have special control over medical devices like this, so that the outcome is prevented before is too late. FDA wants to make clear that even though this device may seem to be harmful, there are precautions that surgeons need to take in order to avoid negative results. These devices require special control there is small number of patients that can develop infection.