Advantages and Technical Pearls for Using the First FDA Cleared Biologic Nipple Reconstruction Implant

Introduction:  Maintaining long-term projection and creating a natural appearance and feel when performing nipple reconstruction continues to be a challenge for plastic surgeons.   The limiting factor is primarily from scar contracture which causes nipple flattening despite the flap technique chosen.  The FDA recently cleared a nipple reconstruction cylinder (Cook Medical, Bloomington, IN) for implantation made from acellular porcine small intestinal submucosa with three different size options.  This device serves as a scaffold to support nipple projection and is later remodeled and biologically replaced as the patient generates new tissues.  

Methods:  This study reviews the author's experience with placement of this cylinder in combination with a C-V flap technique.  Additional technical steps chosen by the author include suture anchoring the cylinder in an ideal position within the reconstructed nipple, creating a tight seal around the cylinder during closure, utilizing Nitro-BID paste on the reconstructed nipple postoperatively to increase local blood supply, and using a nipple shield for six weeks postoperatively to protect the nipple from compression.

Results:  Over twenty-five cylinders were placed using a C-V flap technique in patients with implant reconstruction.  This included patients with skin flaps of varying thickness, varying muscle coverage, and post-radiation therapy.  There was no increase in operative time due to the rapid (10 second) rehydration of the prefabricated product.  Early complications were rare and were treated successfully.  Three and six month data and photographs support maintenance of postoperative projection and overall appearance.

Conclusion:  The author's experience demonstrates that placement of the cylinder using meticulous technique is safe, rapid, and easily performed in patients with implant reconstruction.  The cylinder provides patients with good long term projection and a natural appearance and feel.  Further studies are needed to identify long term patient satisfaction and to advance procedural technique.