Use of the Acellular Dermal Matrix in Revisionary Aesthetic Breast Surgery

Methods 

A retrospective chart review was conducted of 78 consecutive patients who underwent revisionary breast augmentation/mastopexies with ADM during a period of slightly more than two years (October 2005 to January 2008). Patients undergoing surgery for implant rupture, implant malposition, or other reasons without ADM were not included. Only charts with complete operative reports or those in which the use of the ADM could be definitively ascertained were included in the study. Data were collected regarding the original augmentation date, the original implant location (subpectoral or subglandular), type of incision used, volume of the implant used, revision date, type of implant used for revision, incision used in revision, length of follow-up, and any complications that ensued.

All patients received perioperative antibiotics, with the majority receiving first-generation cephalosporin. All surgical pockets were irrigated with triple antibiotic solutions and the implants were bathed in the same solution before insertion into the new pocket. The implants were handled as little as necessary to minimize possible contamination.

For patients whose original implants were subglandular, a site change to a subpectoral plane was performed, with lower pole coverage with ADM. For patients whose original implants were placed subpectorally, a neopectoral pocket was dissected, with the addition of an ADM. For patients who did have adequate breast tissue, a subfascial pocket with an ADM sling was fashioned. In the subpectoral procedures, the pectoralis major muscle was released entirely across its inferior origin and the subpectoral pocket was released as far medially as necessary to achieve the desired pocket shape and medial breast border. Three to five half-mattress stabilizing marionette sutures were placed between the skin and the ADM to stabilize the tissue and hold it in the desired location (Figure 2).

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Figure 2. The acellular dermal matrix is secured with marionette sutures. This process is depicted in both the intraoperative photo (A) and the illustration (B).

Six different types of ADM products were used for this series (Table 1). The majority of patients received Alloderm or Strattice (LifeCell, Branchburg, NJ), FlexHD or DermaMatrix (MTF, Edison, NJ) or SurgiMend (TEI Biosciences, Boston, MA). The majority of the products were listed as thick on the product label (if a product description was available). All dermal products were soaked in triple antibiotic solution before placement.

Table 1. Products studied

	Product name	Manufacturer	Origin	Method of preservation	Year introduced	Time to hydrate	Shelf life	Refrigeration required?
	Alloderm	LifeCell	Human dermal collagen	Lyophilized, patented freeze-drying process prevents damaging ice crystals from forming	1994	20–40 minutes with saline solution step bath with agitation	2 years	Yes
	Neoform	Regeneration Technologies Tutogen Medical, for Mentor	Human dermal collagen	Solvent dehydrated; gamma-irradiated	2007	A few minutes with room temperature saline	5 years	No
	DermaMatrix	Processed by MTF for Synthes CMF	Donated acellular human dermis	Aseptic processing method, lyophilized	2005	None	18 months or 3 years	No
	FlexHD	Processed by the MTF for Ethicon	Donated acellular human dermis	Aseptic processing method, lyophilized	2007	None	18 months or 3 years	No
	SurgiMend	TEI Biosciences	Fetal bovine dermal collagen	Terminally stabilized	2007	60 seconds with room temperature saline	3 years	No
	Strattice	LifeCell	Porcine dermal collagen	Patented freeze-drying process that prevents damaging ice crystals from forming	2008	Minumum of 2 minutes in sterile saline	?	No

MTF, Musculoskeletal Transplant Foundation.

Results 

A total of 78 patients who met all of the criteria for this review were identified. Fifty-six patients had their original implants in the subpectoral position and 22 had them in the subglandular position. The average time from initial operation to revision was seven years, nine months (originally subpectoral: seven years, 11 months; originally subglandular: seven years, six months). The average time for follow-up after pocket conversion was at least 12 months for all patients (originally subpectoral: 11.9 months; originally subglandular, 12.1 months; Table 2). Eleven patients (20%) with previous subpectoral implants were noted to have implant rupture at the time of revision and the previous subglandular implants were ruptured in five patients (23%).

Table 2. Time interval for conversion

			Previous implant
		Total	Subpectoral	Subglandular
	No. of patients	78	56	22
	Time to revision, months	93	95	90
	Follow-up, months	12	11.9	12.1

Among the 56 patients with previously subpectoral implants, 11 patients were found to have ruptured implants. Five patients had silicone gel–filled implants, three patients had double-lumen implants in which only the saline component was found to be ruptured, and three patients had a double-lumen implant in which both components showed evidence of rupture. Among the 22 patients with original subglandular implants, five patients were found to have ruptured implants. All five patients had silicone gel–filled implants. None of the patients with ruptured implants had any preoperative complaints or physical findings suggestive of implant rupture.

Forty-five patients (60%) had replacement with silicone gel–filled implants (five smooth, 40 textured) and 33 (40%) had replacement with form-stable, highly cohesive gel implants (Table 3). Complications included two patients (2.5%) requiring reoperation, one for a hematoma and the other for an implant malposition (Table 4).

Table 3. Types of implants used as replacements

		Total	Silicone gel-filled	Cohesive gel
	Total	78	45	33
	Textured	73	40	33
	Smooth	5	5	—

Table 4. Complications

	Complication	No. of patients
	Hematoma	1
	Seroma	2
	Implant malposition	1
	Implant rupture	0
	Infection	0
	Total	4

Of the 54 patients whose implants were initially subpectoral, 23 patients (43%) had silicone gel–filled implants, 15 patients (28%) had double-lumen implants, and 16 patients (30%) had saline implants. Of the 31 patients whose implants were originally subglandular, 20 patients (65%) had silicone gel–filled implants, three patients (10 %) had double-lumen implants, and eight patients (26%) had saline implants.

Presenting clinical signs are listed in Table 5 and the types of operations performed are listed in Table 6. As expected, the majority of complaints were related to implant hardening. Of 78 patients, 77 (98.5%) were assessed as having soft implants with a Baker I level of CC at final follow-up; one patient (1.5%) had a Baker II CC. No patients had a Baker III or Baker IV classification postoperatively (Table 7, Table 8, Table 9). Between January 2008 and January 2009, an additional 41 cases have been performed for CC, increasing the total number of patients in the series to 119. Because we established a minimum follow-up period of one year, we have not included them in this series. However, it is worth noting that all of these newer patients have maintained a Baker I classification at a mean follow-up of 6.2 months. Results from the study are shown in Figure 3, Figure 4, Figure 5, Figure 6.

Table 5. Clinical signs at presentation

	Clinical signs	No. of patients
	Capsular contracture	56
	Implant exposure	2
	Rippling	7
	Implant malposition	5
	Bottoming out	4
	Symmastia	4
	Total	78

Table 6. Augmentation versus augmentation mastopexy

		No. of patients
	Augmentation	49
	Augmentation/mastopexy	29
	Total	78

Table 7. Preoperative and postoperative Baker classification of patients with originally subpectoral implants

		Percent of patients
	Baker classification	Preoperative	Postoperative
	I	5.4	98.5
	II	21.1	1.5
	III	67.9	0
	IV	5.6	0

Table 8. Preoperative and postoperative Baker classification of patients with originally subglandular implants

		Percent of patients
	Baker classification	Preoperative	Postoperative
	I	9.1	97.4
	II	18.2	2.6
	III	54.5	0
	IV	18.2	0

Table 9. Preoperative and postoperative Baker classification in all patients

		Percent of patients
	Baker classification	Preoperative	Postoperative
	I	6.4	97.4
	II	20.5	2.6
	III	64.1	0
	IV	9.0	0

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Figure 3. A, C, E, Preoperative views of a 42-year-old woman who had undergone multiple previous augmentation procedures. B, D, F, Sixteen months after revision augmentation mastopexy with circumvertical purse-string approach and an acellular dermal matrix. Her large implants were exchanged for higher-profile, lower-volume textured implants.

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Figure 4. The patient in Figure 3 is shown one year postoperatively.

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Figure 5. A, C, E, Preoperative views of a 40-year-old woman who had undergone multiple previous augmentation procedures. B, D, F, Fourteen months after mastopexy with an inframammary fold approach and acellular dermal matrix. Her implants were exchanged for textured silicone gel–filled implants.

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Figure 6. A, C, E, Preoperative views of a 35-year-old woman with previous subpectoral augmentation with saline implants, with extrusion and lamellar scarring. B, D, F, Fourteen months after mastopexy with acellular dermal matrix. Her implants were exchanged for textured silicone gel–filled implants.

Discussion 

The successful use of ADM products has been reported in a wide range of clinical settings, including abdominal wall repair, hernia repair, facial and eyelid surgery, cleft palate repair, soft tissue augmentation, tendon repair, ulcer repair, vaginal sling repair, and breast reconstruction.18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28 Immediate breast reconstruction using tissue expanders or implants has become one of the most commonly used surgical techniques, which has made visible rippling and contour deformity a more frequently encountered problem.31 Therefore, the applications of ADM to breast reconstruction have been of particular interest to plastic surgeons. The recent addition of allogenic tissue supplements avoids the problems of autologous tissue coverage and provides camouflage, thereby decreasing rippling and increasing soft tissue padding.32 This rising demand, coupled with good outcomes in breast reconstruction, has spurred tremendous interest about ADM use in aesthetic breast patients, particularly in the management of CC.

In the past, revisionary surgeries for CC were generally performed with a total capsulectomy, removal of the implant from the subglandular plane, and the placement of a new implant in the subpectoral position.1, 4, 16 This is a fairly simple procedure involving a change in implant placement from over the muscle to under the muscle. More recently, it has become necessary to perform revisionary surgery on volume-depleted breasts as a result of large implants that were placed under the muscle or severe scarring in the breasts. We remain plagued with a paucity of tissue, leading to the use of allogenic materials such as ADM.

Our experience with 78 patients—all of whom uniformly had their implant-related complications successfully corrected by a site change and the use of an ADM—provides a number of important conclusions. First, the use of ADM enhanced soft tissue thickness or cushioning (Figure 5), decreasing and eliminating the visibility of implants. Second, the use of these products increased our ability to successfully manage implant displacements and their recurrence. Third, lower pole thickness was enhanced in patients with dual plane or neopectoral pocket conversions, especially in those undergoing concurrent mastopexies, interposing regenerative tissue between skin closure and implant (lamellar interpositioning) (Figure 6). Lastly, it is of interest that 56 patients with Baker grade III and IV CC had their CC treated successfully.

The addition of the ADM to the management of breast augmentation intricacies gives us an exciting and, according to our data, reliable new surgical option. It is evident that by replacing the missing tissue at the implant interface, we are able to create an environment that is conducive to healing without excessive scarring (Figure 1). Unpublished results from our animal studies show decreased inflammation within the implanted pocket at different time points with the addition of ADM.33 Just as with any process that leads to excessive scarring, the key is to control the inflammatory phase and allow the healing tissue to transition quickly and smoothly to the next (proliferative) phase. It is also important to keep in mind that the true etiology of CC remains multifactorial and, by controlling all of the factors, we are able to see the future in prevention of this complicated and prolonged issue.

ADM is not a miracle product that can eliminate CC, but it serves as an adjunct to the already well-described principles in the management of CC, such as aseptic techniques with appropriate antibacterial pocket irrigations, postoperative drains, and the placement of textured implants.1, 3, 4, 8, 9, 11, 15, 34 We postulate that in order to have a successful outcome with an ADM, the creation of a new pocket (raw surface) is essential to augment the interface (Figure 2, Figure 3). We do not believe that partial capsulectomy or capsulotomies in conjunction with placement of an ADM are as effective as lining the ADM in a newly vascularized pocket, followed by placement of the implant (Figure 7).

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Figure 7. Interposing regenerative tissue between skin closure and implant (lamellar interpositioning).

With our extensive use of all types of ADM, we have found no differences in terms of complications, as noted by our data. ADM products have their limitations and differences in terms of revascularization and cellular ingrowth and the acceptance between different thicknesses and sterility, but we noted no additional drainage output and no infections related to the sterility of certain products. As previously noted, the majority of products were listed as thick on the product label (if available). It should be noted, however, that the different materials have different biomechanical properties, a discussion of which is beyond the scope of this article.

One obstacle that we will continue to face in aesthetic surgery is the cost–benefit ratio of these materials, as they are expensive. Further evaluation is needed to assess the actual impact of these costs and their documented outcome improvements in our specialty.

Conclusions 

ADM products show promise for applications in revisionary breast surgery and specifically for the treatment of complications of breast augmentation. This report describes different uses of the ADM that allow for the correction of established CC, malposition, and other implant-related issues after previous subglandular or subpectoral breast augmentation.