According to lead researcher and plastic surgery fellow of Emory University, Hunter R. Moyer, using the Funnel in inframammary incisions (under the breast) resulted in a twenty-seven-fold decrease in skin contact for smooth gel implants. Dr. Moyer, also a surgeon at Atlantic Plastic Surgery, found bacterial contamination from breast skin cells was two times less likely using the implant delivery device.
"Breast implant infections are a considerable burden to the patient and the healthcare system," said Dr. Moyer. "In our cadaver study, we concluded that the Keller Funnel™ significantly reduces the amount of skin contact and potential contamination during breast implantation which may lead to reduced patient infection rates and capsular contracture."
Core studies by implant manufacturers cite that capsular contracture, a painful condition where breasts feel hardened and become distorted, occurs in 10 to 15 percent of all women who undergo breast augmentation procedures, and is the most common requiring reoperation. According to the Emory study, "â€¦ contracture remains the single most vexing complication for patients and surgeons. Multiple factors likely cause contracture with infection being a significant contributor."
Typically, silicone gel implants are inserted by a surgeon's gloved hands through incisions located either in the breast fold or through a periareolar incision found around the outside of the nipple. The Keller Funnel™ was designed to facilitate and improve the delivery of silicone gel implants by allowing surgeons to use a minimal or no-touch technique during augmentation procedures. Instead of the finger pushing and thrusting motion required by a surgeon to successfully place an implant in the traditional method, the tip of the Funnel is inserted into the incision and the doctor gently propels the implant into the breast pocket, while protecting the implant from contacting the skin.
To view a short clip demonstrating the procedure with and without use of the Funnel, click here.
Howard Preissman, Keller Medical CEO, believes the rapid adoption rate by surgeons using the Funnel will change the standard of care for the delivery of silicone gel implants. "Based on a recent survey among 300 surgeons with varying degrees of experience using the Funnel, we know that the device improves the delivery of silicone implants by making the procedure easier and that doctors believe it reduces the introduction of contaminants thought to be the major cause of capsular contracture. Other reported benefits to women include significantly reducing force on the implant shell which can prevent a future rupture, shortening incision lengths and minimizing post operative bruising and swelling."
Launched in August 2009, Keller Medical has sold more than 50,000 Funnels and estimates it is used in a 20% of procedures using silicone implants in the U.S. Last year, the company was granted a CE Mark to distribute the single use device in the European Union and now is growing its distribution network in Europe, Asia and Latin America.
To view the study, visit http://aes.sagepub.com/content/early/2012/01/18/1090820X11434505.abstract. Keller Medical, Inc. was co-founded by Board Certified plastic surgeon Kevin Keller, M.D. and Howard Preissman, a medical device executive and biomedical engineer. Both U.S. and international patents are pending. For more information, call 772.219.9993 or visit www.kellerfunnel.com.
Posted by Sean Fenske, Editor-in-Chief, MDT