The next generation of breast implants is under active development by Mentor Corporation aided by input from a group of expert plastic surgeons, engineers and scientists. The group, known as PROJECT LEAD, was assembled by Mentor from recognized experts in plastic surgery and associated sciences fundamental in the development and manufacturing of medical devices. Cohesive silicone breast implants are the latest development in the field. The silicone filler is solid thus alleviating the risk of the implant being unknowingly ruptured. Sometimes known as the ‘gummy bear implant,’ cohesive silicone also offers the ability to shape the device in ways to optimize patient benefit. This anatomical or tear drop shape implant is often ideal for use in patients with very little breast shape of their own or in patients following mastectomy for cancer. The importance of choice in the implant selection process is to be emphasized. Not all patients are going to benefit from the same implant shape. Round implants work well for cosmetic augmentation patients who have some of their own breast shape and volume. These implants are commonly used in primary augmentation in a younger patient or in those correcting post pregnancy changes of volume and or shape loss. Cohesive shaped implants provide great benefit compared to round devices in patients who lack defined breast shape. The results are far superior. PROJECT LEAD has two component advisory boards: one working primarily on cosmetic breast issues and another focusing on the needs of breast reconstruction patients. As the only plastic surgeon invited to participate in both groups, I have been able to offer my patients the latest devices available through these investigative studies. FDA approval of a new implant is a long and expensive process. It assures patients of the safety and effectiveness of their implant choice. However, the cohesive silicone filler used in the Mentor CPG and Allergan 410 implant series is not yet approved for unrestricted use. Both implants are nearing the end of 10 year studies the results of which will hopefully lead to the general use. I have participated in both manufacturers’ studies of cohesive silicone, contributing several dozen patient participants to the 2000 patients selected nationwide. I am confident of the safe usefulness of cohesive silicone breast implants. Continued use of cohesive silicone implants since the completion of study patient enrollment has been limited to use only by those of us surgeons who participated in the studies. I look for FDA hearing on cohesive silicone sometime in fall 2012. .
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