Grand Rapids, Mich. From the Bengtson Center for Aesthetics and Plastic Surgery and Michigan State University School of Medicine. Received for publication May 14, 2012; accepted May 25, 2012. Disclosure:Dr. Bengtson is a consultant and speaker for LifeCell Corporation, the manufacturer of AlloDerm and Strattice. Bradley Bengtson, M.D.; 555 Midtowne St, NE, Suite 110, Grand Rapids, Mich. 49525, [email protected]
Preclinical studies have demonstrated that macroporous silk fibroin protein scaffolds are capable of promoting physiologically durable supportive tissue, which favors application of these engineered tissues for clinical implantation. The safety and effectiveness of a long-lasting, transitory, 510(k)-cleared purified silk fibroin biologic scaffold (SBS) are investigated for soft-tissue support and repair of the abdominal wall.We conducted a multicenter retrospective review of all consecutive patients who underwent abdominal wall soft-tissue reinforcement with an SBS device between 2011 and 2013. Indications, comorbid conditions, surgical technique, complications, and outcomes were evaluated.We reviewed the records of 172 consecutive patients who received an SBS for soft-tissue support. Of those, 77 patients underwent abdominal wall fascial repair, with a mean follow-up of 18.4 ± 7.5 months. Procedures using an SBS included reinforcement of an abdominal-based flap donor site (31.2%), ventral hernia repair (53.2%), and abdominoplasty (15.6%). The overall complication rate was 6.5%, consisting of 2 wound dehiscences, 1 with device exposure, 1 seroma, 1 infection with explantation, and a perioperative bulge requiring reoperation. There were no reports of hernia.Postoperative complication rates after 18 months were low, and most surgical complications were managed nonoperatively on an outpatient basis without mesh removal. To our knowledge, this is the only series to report on a long-lasting, transitory SBS for abdominal wall repair and reinforcement. Procedure-specific outcome studies are warranted to delineate optimal patient selection and define potential device characteristic advantages.
The primary goal of reconstructive and revision surgery is to restore, repair, rebuild, and support damaged, weakened, or absent tissue. There are numerous approaches for soft tissue support and repair, including the use of autologous tissue, human‐ or animal‐derived acellular dermal matrices, absorbable or permanent synthetic mesh, and, now, a new class of bioresorbable protein scaffold. Although many factors influence the choice of surgical approach and the specific product used for soft tissue support and repair, the goal is to improve long‐term outcomes while minimizing complications and recurrences requiring further revisional surgery. In this review, the basic science, clinical characteristics, and clinical applications of SERI ® Surgical Scaffold, a novel, engineered, highly purified silk product for soft tissue support and repair will be presented.
The nipple and areola complex typically provides the final finishing touch of the breast reconstruction, and most surgeons and patients do not believe the breast has been completely reconstructed until this step is completed. There have been literally hundreds of different types of nipple-areolar reconstructions described, along with variations. This chapter reviews the anatomy, timing, options, and the most common techniques used in reconstruction today. In addition, the authors review tattooing options and caveats for success, including choosing a method to best match the contralateral side and bringing in some additional tissue that may be used in the future for the nipple reconstruction.
I read with interest Mr. Aicher's editorial in the Aesthetic Surgery Journal ,1 and wanted to echo and share some of my thoughts and concerns on this new government mandate. Approximately 2 years ago the Centers for Medicare & Medicaid Services (CMS) was tasked by the federal government to oversee and report all payments made to health care providers, owing to concerns that payments from the pharmaceutical industry and medical device companies would influence which medicines or medical devices are used or prescribed to patients. The information from the first phase of this report was recently released.
In 2005, the Department of Justice sued 5 leading medical device companies, citing inducement of product use through consulting relationships designed to encourage physicians to select their products.2 These lawsuits, for the most part, have deterred physicians from engaging in this unethical practice; however, the national government has increased its oversight and has directed the CMS to monitor this activity. The CMS created this department to:
Of these goals, specifically within the context of aesthetic medicine and plastic surgery, the first 2 have been addressed by the American Society for Aesthetic Plastic Surgery (ASAPS) and American Society of Plastic Surgeons (ASPS). Of the remaining 3, it is my opinion that the federal government may not be the best body to hold physicans to any accountability …