A surgical technique using local tissue skate flaps combined with cylinders made from a naturally derived biomaterial has been used effectively for nipple reconstruction. A retrospective review of patients who underwent nipple reconstruction using this technique was performed. Comorbidities and type of breast reconstruction were collected. Outcome evaluation included complications, surgical revisions, and nipple projection. There were 115 skate flap reconstructions performed in 83 patients between July 2009 and January 2013. Patients ranged from 32 to 73 years old. Average body mass index was 28.0. The most common comorbidities were hypertension (39.8%) and smoking (16.9%). After breast reconstruction, 68.7% of the patients underwent chemotherapy and 20.5% underwent radiation. Seventy-one patients had immediate breast reconstruction with expanders and 12 had delayed reconstruction. The only reported complications were extrusions (3.5%). Six nipples (5.2%) in 5 patients required surgical revision due to loss of projection; two patients had minor loss of projection but did not require surgical revision. Nipple projection at time of surgery ranged from 6 to 7 mm and average projection at 6 months was 3–5 mm. A surgical technique for nipple reconstruction using a skate flap with a graft material is described. Complications are infrequent and short-term projection measurements are encouraging.
In 2013, the American Cancer Society estimated that 232,340 new cases of invasive breast cancer would be diagnosed in women. Nipple-areola reconstruction is the last stage in a long and multifaceted journey to restore the presurgical appearance of a person’s breast following mastectomy. The presence of a nipple on a reconstructed breast has been shown to be psychologically significant for women who have had mastectomies [
The Biodesign Nipple Reconstruction Cylinder (NRC; COOK Inc., Bloomington, IN) is a rolled cylinder of extracellular matrix collagen derived from porcine small intestinal submucosa (SIS) and is intended for implantation to reinforce soft tissue in plastic and reconstructive surgery of the nipple (Figure
Image of the Biodesign Nipple Reconstruction Cylinder (COOK Inc., Bloomington, IN). Cylinders have a length of either 1.0 cm or 1.5 cm and a diameter of either 0.7 cm or 1.0 cm. All sizes can be trimmed prior to implantation.
Although some patients decide not to proceed with nipple-areolar reconstruction, the nipple is considered to be a well-defined anatomic marker that contributes significantly to the shape and symmetry of the breast [
A retrospective, single-center, single-surgeon, chart review was performed on all postmastectomy breast reconstruction patients who underwent skate-flap nipple reconstruction in combination with a Biodesign NRC between July 2009 and January 2013. Patient demographic data including age, weight, indication for surgery, and cancer stage were collected. Other risk factors, including smoking, preoperative and postoperative chemotherapy, and radiation therapy, were also collected and analyzed. The surgery dates, types of mastectomy, and types of breast reconstruction were recorded for every patient. Outcome evaluations included complications, the need for surgical revision, and nipple projection measurements.
Nipple cylinder diameter (0.7 cm or 1.0 cm) and length (1 cm or 1.5 cm) were selected to closely match the contralateral nipple. If a contralateral nipple was not present, the overall size of the reconstructed breast, the presence or absence of a well-vascularized skin flap, and/or the patient’s desired final appearance were considered when determining the cylinder size, allowing for some shrinkage following implant. The position of the nipple was determined with the patient seated in a relaxed position. Using a surgical marker, a skate-flap pattern (Figure
Skate-flap pattern drawn onto the patient’s breast to guide the creation of the skin flap.
Intraoperative pictures. (a) Skate flap comprised of skin and fatty tissue is cut and lifted along the surgical markings; (b) the ends of the flap are brought together and sutured to allow for cylinder placement; (c) the cylinder is carefully placed inside the flap, (d) resulting in the cylinder being securely wrapped by vascularized skin tissue.
There were 83 women who underwent postmastectomy breast reconstruction and subsequent nipple reconstruction. The average age was 50.4 years (range: 32–73 years) and average body mass index was 28.0 (range: 15.8–48.4). Thirty-three patients (39.8%) had a diagnosis of hypertension, 14 (16.9%) used tobacco products, and 9 (10.8%) had type II diabetes at the time of reconstruction (see Table
Patient demographics.
Total number of patients = 83 | |
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Age | Range: 32–73 years old |
Mean: 50.4 years old | |
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BMI | Range: 15.8–48.4 |
Mean: 28.0 | |
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Indication for surgery | IC = 40 patients (48.2%) |
DCIS = 35 patients (42.2%) | |
LC = 1 patient (1.2%) | |
Paget’s = 1 patient (1.2%) | |
BRCA+ = 1 patient (1.2%) | |
Benign mass = 1 patient (1.2%) | |
Unknown = 4 patients (4.8%) | |
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Diabetes (Type II) | 9 patients (10.8%) |
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Hypertension | 33 patients (39.8%) |
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Smoking (or tobacco products) | 14 patients (16.9%) |
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Preoperative chemotherapy | 22 patients (26.5%) |
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Postoperative chemotherapy | 48 patients (57.8%) |
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Chemotherapy alone |
42 patients (50.6%) |
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Preoperative radiation | 6 patients (7.2%) |
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Postoperative radiation | 14 patients (16.9%) |
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Radiation alone |
2 patients (2.4%) |
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Combined chemotherapy and radiation | 15 patients (18.1%) |
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No adjuvant cancer treatment | 8 patients (9.6%) |
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Unknown cancer treatment | 16 patients (19.3%) |
IC: infiltrating carcinoma, DCIS: ductal carcinoma in situ, LC: lobular carcinoma, Paget’s: Paget’s disease of the nipple, and BRCA+: positive breast cancer gene.
Using a skate-flap and graft technique in combination with the Biodesign NRC, the total number of nipple reconstructions was 115 (61 unilateral reconstructions and 27 bilateral reconstructions). The only reported complications included 4 cases (3.5%) of NRC extrusion and 5 patients (4 unilateral and 1 bilateral reconstructions, 5.2%) who required surgical revision due to loss of nipple projection (see Table
Nipple reconstruction complications.
Patient | Date of nipple reconstruction | Surgery procedure used | NRC: L, R, or bilateral | Complications |
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1 | 7/10/2009 | Skate + NRC | Left | Lost projection, surgical revision required |
10/16/2009 | Revision with second NRC | |||
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2 | 1/19/2011 | Skate + NRC | Bilateral | Lost projection, surgical revision required |
4/5/2011 | Revision with second NRC | |||
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3 | 4/12/2011 | Skate + NRC | Right | Cylinder extrusion 3 weeks post-op; projection still viable, no surgical revision required |
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4 | 3/28/2011 | Skate + NRC | Right | Patient displeased with projection, surgical revision required |
7/26/2011 | Revision with second NRC | |||
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5 | 5/18/2011 | Skate + NRC | Left | Cylinder extrusion 2 weeks post-op; projection still viable, no surgical revision required |
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6 | 2/7/2012 | Revision with NRC | Right | Loss of projection due to radiation therapy; cylinder extrusion 3 weeks post-op; projection still viable, no surgical revision required |
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7 | 9/30/2011 | Skate + NRC | Right | Lost projection, surgical revision required |
10/26/2012 | Revision with second NRC | |||
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8 | 10/5/2011 | Skate + NRC | Left | Cylinder extrusion 4 weeks post-op; lost projection, surgical revision required |
3/9/2012 | Revision with second NRC | |||
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9 | 10/14/2012 | Skate + NRC | Left | Lost projection, surgical revision required |
2/24/2012 | Revision with second NRC |
Skate: skate-flap nipple reconstruction technique and NRC: Biodesign Nipple Reconstruction Cylinder.
Nipple projection at time of surgery ranged from 6 to 7 mm.
(a) Patient before breast and nipple reconstruction. (b) Same patient after breast and nipple reconstruction.
Published information for nipple-areola reconstruction reveals numerous surgical techniques and variable long-term results in terms of patient satisfaction and sustained nipple projection. Some of the different techniques and local flaps that are used for nipple reconstruction, besides the skate-flap, are the Marshall technique [
Surgeon preference is usually what determines the surgical method of choice for nipple reconstruction. It is difficult to conclude if there is one method that yields superior results than others because very few evidence-based comparisons have been published. It is expected, however, that with every surgical technique for nipple reconstruction that exists today there will be variations in the results, complications, and some degree of projection loss with time. Modifications of current surgical techniques and new device technologies are continuously being developed and tested for lower complication rates and longer lasting nipple projection.
The only cases in this series that required surgical revision were due to loss of nipple projection or cylinder extrusion. The cause of the loss of nipple projection is unknown but may be related to individual patient characteristics or noncompliance in wearing the plastic shield following surgery. Four patients suffered from extrusion of the Biodesign NRC between 2 and 4 weeks after surgery but only 1 patient required further surgical revision. The most likely reason for cylinder extrusion was tension on the sutures that lead to a small degree of tissue ischemia and necrosis of part of the flap. Other risks of nipple reconstruction reported in the literature include localized tip/flap necrosis, partial flap loss, complete flap loss/infection, dehiscence, seroma formation, and an overall expected complication rate of approximately 12% in all patients [
The intended goal of this retrospective case series was to describe a successful skin flap technique and device combination that could be used to reconstruct the nipple-areola complex following the removal and reconstruction of breast tissue. The potential clinical benefits to the subjects are a surgery that can be performed quickly and with minimal morbidity, providing safe, predictable, and long-lasting aesthetic results. Seventy-eight out of 83 patients (94.0%) underwent skate-flap nipple reconstruction in combination with the Biodesign NRC and had no complications. At the time of surgery, average nipple projection ranged from 6 to 7 mm and average projection at 6 months was 3–5 mm, representing a 30%–50% percent loss of projection, which is similar to the projection loss noted following local skin flap nipple reconstruction without graft material augmentation [
Alternative treatments to the nipple cylinder for reconstruction include cosmetic tattooing of the areola only, local skin flap nipple reconstruction without graft material augmentation, autologous or composite grafts (i.e., contra lateral nipple, fat grafting, or cartilage) [
Currently, more comparative clinical studies are needed to optimize the procedures used to reconstruct the nipple-areola complex following mastectomy. With the use of the Biodesign NRC, there is a potential for reducing patient complications, providing longer-lasting nipple projection and achieving higher patient satisfaction than either autologous graft procedures or flap procedures alone. A combined surgical technique for nipple reconstruction that used a skate flap and an off-the-shelf biologic graft material that resulted in comparable aesthetic results to alternative treatments and promising long-lasting projection was presented. Complications are infrequent and short-term projection measurements are encouraging. Longer-term followup is needed to determine if nipple projection is sustained for longer periods of time and if the added cost of the cylinder is justified by long-term aesthetic outcome.
Patient consent was obtained for the reporting of case results and the principles of the Declaration of Helsinki were followed.
This paper is not currently under consideration, in press, or published elsewhere. This paper is truthful original work without fabrication, fraud, or plagiarism.
No financial support or benefits have been received by Dr. Brian P. Tierney (1st author) from any commercial source which is related directly or indirectly to the scientific work which is reported on in the paper except as described as follows. Jason P. Hodde (2nd author) and Daniela I. Changkuon (3rd author) are employed by Cook Biotech Incorporated (W. Lafayette, IN) and provided support for research activities, writing, and editing of the paper.
All authors have made an important scientific contribution to this study, are familiar with the primary data, and have read the entire paper and take responsibility for its content.