Dr Barry Eppley, Plastic Surgeon of Indianapolis, Patents a New Filler Material for Breast Implants for use in Breast Augmentation (Patent No. 6,187,044)
Breast implants used for breast augmentation and breast reconstruction are currently filled with saline or variations in gel forms of silicone. Both saline and silicone filler materials for breast implants have their advantages and disadvantages. Saline-filled breast implants have the disadvantages of cosmetic rippling and the risk of spontaneous deflation should the breast implant shell rupture. Silicone-filled breast implants have the disadvantage of being pre-filled, making their insertion more difficult with a bigger incision needed and no opportunity for adjustment in size after they are inserted.
After years of laboratory work, Dr. Barry Eppley of Indianapolis developed a potential different material for the use of filling breast implants which is chemically different than that of saline or silicone. This filler composition is a nonionic surfactant, polysorbate, which is a fatty acid ester of sorbitol. Polysorbates are most known as hydrophilic nonionic surfactants which are used as emulsifying agents for the preparation of stable oil-in-water emulsions in pharmaceutical products. ‘Advantageously, the nonionic surfactants are safe and biodegradable in the event of leakage from the breast implant,” according to Dr. Barry Eppley who has worked with the materials for years in Indianapolis as injectable carriers for soft tissue filling materials. If the filler material escapes from the breast implant, it is broken down by normal metabolic processes without an inflammatory reaction. Dr Barry Eppley states that other advantages of the material includes; it is radiolucent so there is no interference with mammograms or MRI, its high viscosity (compared to saline) eliminates the issue of cosmetic rippling and decreases the risk of implant rupture, and it is injectable which silicone is not. In addition, according to Dr Barry Eppley, the filler material has a documented history of clinical use in topical, oral, and intravenous forms of human use. The filler material are also capable of being mixed with water to create varying ratios of polysorbate-water filler materials for breast implants.
Dr Barry Eppley states that this patented material needs a lot of clinical work but it falls into one of the numerous breast implant filler materials that are currently being evaluated as alternatives to silicone and saline in breast augmentation and breast reconstruction.