Alloderm - Association For Medical Ethics

Predictive Value
for Success

EXCELLENT
> 25% of all studies are Level I

GOOD
> 25% of all studies are Level II or better

FAIR
> 25% of all studies are Level III or better

POOR
> 25% of all studies are Level IV or better

VERY POOR
< 25% of all studies are Level IV or better

Evidence Based
Medicine
Level Rating System

LEVEL I
Randomized, controlled clinical trials - This is the most objective and valid study results. This study has posted the highest level of quality for evidence based medicine.

LEVEL II
Prospective non-randomized, comparative studies - This is the second most objective and valid study results.

LEVEL III
Retrospective comparative or case controlled studies - These studies look back historically and compare them with other cases in the past. The problem with this system is that these past patients may not have been chosen or treated - or not treated at all - on equal standings.

LEVEL IV
Case Series - This where a group of patients have a particular treatment, and then observations are made about them. This does not differentiate between the success or failure of the treatment compared to other treatments or no treatment at all. For example treating back pain for 10 days by drinking pomegranate juice may show all patients got better and conclude this should be the treatment for back pain. However, usually all back pain gets better in 10 days no matter what one does.

LEVEL V
Expert opinion. This is a person's opinion only. It's an editorial, and is considered the lowest level of evidence to support a position. AME considers this to be Comparable to hearsay.

For More Information
On Evidence Based Medicine
Rating System Click Here

AME Star Rating System

ALLODERM
The Use of Alloderm in Breast Reconstruction Surgery

ALLODERM

AME STAR RATING:
POOR Predictive Value for success of procedure

METHOD: Peer reviewed English language publications of human, Theraputic Studies only - investigating the efficacy and safety of Alloderm in breast reconstruction. Repetitive evaluation and simular results of same data sets were not included.

TOTAL: 19 ALLODERM STUDIES
Studies FAVORABLE Click Here to see studies	17 Studies	17 Level IV
Studies UNFAVORABLE Click Here to see study	0 Studies
Studies NEUTRAL Click Here to see studies	2 Studies:	2 Level III
The preponderance of studies are favorable, but are exclusively level IV evidence and therefore a Two Star ** rating (>25% of studies are Level IV). Although the product may be better then others in the same category, there is lack of high levels of evidence to support this.

Click Here for description of Evidence Based Medicine Click Here for description of AME Rating System

REFERENCES

ALLODERM
Studies Favorable: Total 17

Level IV: 17 Studies

1. Inferolateral AlloDerm hammock for implant coverage in breast reconstruction.
Breuing KH, Colwell AS.
Plast Reconstr Surg. 2007 May;119(6):1663-8.
Study Design: Case series
Level IV - FAVORABLE for Alloderm: Implant reconstruction with an inferolateral AlloDerm hammock facilitates positioning of the implant in immediate or revisional breast reconstruction and simplifies expander-implant reconstruction. This safe technique is easy to learn and should be considered a viable option for breast reconstruction.

2. Use of AlloDerm in primary nipple reconstruction to improve long-term nipple projection.
Garramone CE, Lam B.
Plast Reconstr Surg. 2007 May;119(6):1663-8
Study Design: Case series
Level IV - FAVORABLE for Alloderm: The authors' results demonstrate that the use of a modified star dermal flap pattern with the placement of an AlloDerm graft core is a safe, easily performed, and reproducible technique for improving the long-term maintenance of projection in reconstructed nipples.

3. Use of regenerative human acellular tissue (AlloDerm) to reconstruct the abdominal wall following pedicle TRAM flap breast reconstruction surgery.
Glasberg SB, D'Amico RA.
Plast Reconstr Surg. 2006 Jul;118(1):8-15
Study Design: Case series
Level IV - FAVORABLE for Alloderm: Based on these results, the authors recommend the use of AlloDerm as an alternative option for abdominal fascia closure after TRAM flap harvest for breast reconstruction.

4. Immediate bilateral breast reconstruction with implants and inferolateral AlloDerm slings.
Breuing KH, Warren SM.
Ann Plast Surg. 2005 Sep;55(3):232-9.
Study Design: Case series
Level IV - FAVORABLE for Alloderm: This technique shortens or eliminates the need for tissue expansion and provides an additional option for single-stage breast reconstruction with implants. We have selectively used this technique as a reconstructive option for 10 women undergoing bilateral mastectomy (20 breasts).

5. Implant-based breast reconstruction with allograft.
Zienowicz RJ, Karacaoglu E.
Plast Reconstr Surg. 2007 Aug;120(2):373-81.
Study Design: Case series
Level IV - FAVORABLE for Alloderm: Breast reconstruction with implant and AlloDerm enables the surgeon to create a submuscular pocket large enough to place a fully inflated breast implant. Interposition of a lower-pole internal sling, to increase the capacity of the pectoralis major pocket while providing immediate ability to achieve full or subtotal prosthetic fill and optimal aesthetic breast contouring and to maintain thicker muscle coverage in the upper and medial pole areas and stronger lower pole support, would obviate many of the current disadvantages to implant reconstruction.

6. Immediate single-stage breast reconstruction using implants and human acellular dermal tissue matrix with adjustment of the lower pole of the breast to reduce unwanted lift.
Topol BM, Dalton EF, Ponn T, Campbell CJ.
Ann Plast Surg. 2008 Nov;61(5):494-9.
Study design: Case series
Level IV - FAVORABLE for Alloderm: Human acellular dermal tissue matrix can successfully be used in conjunction with breast implants to achieve an aesthetically pleasing breast reconstruction in one stage at the time of skin-sparing mastectomy. The use of a tissue expander and its associated risks and costs are eliminated. The complication rate is low. In addition, either inframammary fold reconstruction or lower chest advancement and fold reconstruction to augment lower pole skin coverage can improve symmetry with the opposite breast.

7. Implant breast reconstruction using acellular dermal matrix.
Gamboa-Bobadilla GM.
Ann Plast Surg. 2006 Jan;56(1):22-5.
Study design: Case series
Level IV - FAVORABLE for Alloderm: The use of a human acellular dermal matrix in breast reconstruction is an alternative protocol in high-risk patients, resulting in a minimal increase in operative time and a decrease in morbidity compared with more extensive procedures.

8. Correction of chest wall deformity after implant-based breast reconstruction using poly-L-lactic acid (Sculptra).
Schulman MR, Lipper J, Skolnik RA
Breast J. 2008 Jan-Feb;14(1):92-6.
Study design: Case series
Level IV - UNFAVORABLE for Alloderm: Placement of acellular cadaveric dermis (Alloderm) failed to improve the appearance of her chest wall. The authors utilized poly-L-lactic acid (Sculptra) for soft tissue augmentation of her chest wall with significant esthetic improvement. This novel use of poly-L-lactic acid offers a useful alternative to invasive surgical procedures to correct a soft tissue deformity of the chest wall. While poly-L-lactic acid has recently gained popularity for soft tissue augmentation of the face, to date, no reports in the literature exist describing its use in the correction of difficult chest wall defects after mastectomy and implant reconstruction. We maintain that poly-L-lactic acid may also be useful to improve a variety of soft tissue deformities of the breast.

9. Nonexpansive immediate breast reconstruction using human acellular tissue matrix graft (AlloDerm).
Salzberg CA.
Ann Plast Surg. 2006 Jul;57(1):1-5.
Study design: Case series
Level IV - FAVORABLE for Alloderm: In this population, 49 patients (76 breasts) successfully underwent the acellular tissue matrix-based immediate reconstruction, resulting in durable breast reconstruction with good symmetry. These findings may predict that acellular tissue matrix-supplemented immediate breast reconstruction will become a new technique for the immediate reconstruction of the postmastectomy breast.

10. Acellular dermis-assisted breast reconstruction.
Spear SL, Parikh PM, Reisin E, Menon NG.
Aesth Plast Surg (2008) 32:418–425
Study design: Case series
Level IV - FAVORABLE for Alloderm: Acellular dermis appears to be a useful adjunct in immediate prosthetic breast reconstruction. Acellular dermis-assisted breast reconstruction has a low complication rate, helps to reconstruct an aesthetically pleasing breast, and facilitates expeditious completion of the reconstruction.

11. Immediate single-stage breast reconstruction using implants and human acellular dermal tissue matrix with adjustment of the lower pole of the breast to reduce unwanted lift.
Topol BM, Dalton EF, Ponn T, Campbell CJ.
Ann Plast Surg. 2008 Nov;61(5):494-9
Study design: Case series
Level IV - FAVORABLE for Alloderm: Human acellular dermal tissue matrix can successfully be used in conjunction with breast implants to achieve an aesthetically pleasing breast reconstruction in one stage at the time of skin-sparing mastectomy. The use of a tissue expander and its associated risks and costs are eliminated. The complication rate is low. In addition, either inframammary fold reconstruction or lower chest advancement and fold reconstruction to augment lower pole skin coverage can improve symmetry with the opposite breast.

12. Intracapsular allogenic dermal grafts for breast implant-related problems.
Baxter RA.
Plast Reconstr Surg. 2003 Nov;112(6):1692-6; discussion 1697-8
Study design: Case series
Level IV - FAVORABLE for Alloderm: Techniques for use of allogenic dermal grafts and early results from 10 patients are summarized in this article, along with histologic analysis confirming viability of the grafts at 6-month follow-up in one patient. No graft-related complications were identified.

13. Use of acellular cadaveric dermis and tissue expansion in postmastectomy breast reconstruction.
Bindingnavele V, Gaon M, Ota KS, Kulber DA, Lee DJ.
J Plast Reconstr Aesthet Surg. 2007;60(11):1214-8. Epub 2007 Apr 25. Review
Study design: Case series
Level IV - FAVORABLE for Alloderm: The use of ACD in expansive postmastectomy breast reconstruction has an extremely low complication rate, results in good cosmetic outcome, and should be in the repertoire of plastic surgeons. Further follow up is needed to evaluate the long term outcomes of ACD use in postmastectomy breast reconstruction.

14. Alloderm (Acellular Human Dermis) in Breast Reconstruction with Tissue Expansion
Julio Hochberg, MD; Aaron Margulies, MD; James C. Yuen, MD; Julie Kepple, MD;
Rhonda H. Tillman, MD; Scott Dorroh, BS; Amanda Pennington, RN; Kent Westbrook, MD;
Suzanne Klimberg, MD
Plastic & Reconstructive Surgery. Abstract Supplement. 116, no 3, 2005
Study design: Case series
Level IV - FAVORABLE for Alloderm: The acellular human dermis allograt (Alloderm) is excellent for closure of the sub-pectoral pocket in breast reconstruction with tissue expanders. It maintains proper support of the fully inflated tissue expander without lateral displacement.The patient has immediate satisfaction with some breast volume and cleavage appearance, with a low rate of complications.

15. Immediate Breast Reconstruction with Tissue Expanders and Alloderm.
Parikh, Pranay M. MD; Spear, Scott L. MD; Menon, Nathan MD; Reisin, Elan MD
Plastic & Reconstructive Surgery. Abstract Supplement. 118(4) Supplement:18, September 15, 2006.
Study design: case series
Level IV - FAVORABLE for Alloderm: Alloderm appears to be a useful adjunct in immediate prosthetic breast reconstruction. Use of Alloderm has a low complication rate, helps create an aesthetically pleasing breast, and affords an expeditious reconstruction.

16. Secondary Nipple Reconstruction Using Local Flaps and AlloDerm
Nahabedian, Maurice Y. M.D.
Plastic & Reconstructive Surgery. 115(7):2056-2061, June 2005.
Study Design: Case series
Level IV - FAVORABLE for Alloderm: Secondary nipple reconstruction using AlloDerm results in improved nipple projection. This was demonstrated in seven of eight nipple reconstructions (88 percent). In the only nipple that flattened, a tertiary reconstruction again using AlloDerm resulted in good projection. This limited experience has demonstrated that AlloDerm is simple to use, well tolerated, and has the potential for improved long-term nipple projection. Further studies are warranted.

17. CHEST WALL RECONSTRUCTION WITH ACELLULAR DERMAL MATRIX (AlloDerm) AND A LATISSIMUS MUSCLE FLAP
Cothren, C Clay M.D.; Gallego, Kelly M.D.; Anderson, Erica D. M.D.; Schmidt, Douglas M.D.
Plastic and Reconstructive Surgery Volume 114(4), 15 September 2004, pp 1015-1017
©2004American Society of Plastic Surgeons
Study Design: Case Report
Level IV - FAVORABLE for Alloderm: Although five pieces of AlloDerm had to be pieced together to span the 20 × 20-cm chest wall defect, it proved an ideal material, providing adequate structural stability and graftability without becoming infected, as could have happened with other prosthetic materials, despite partial inferior flap necrosis.

ALLODERM
Studies Unfavorable: Total 0

ALLODERM
Studies Neutral: Total 2

Level III: 2 Studies

1. AlloDerm versus DermaMatrix in immediate expander-based breast reconstruction: a preliminary comparison of complication profiles and material compliance.
Becker S, Saint-Cyr M, Wong C, Dauwe P, Nagarkar P, Thornton JF, Peng Y. Plastic and Reconstructive Surgery, Jan 2009, Vol 23, no. 1
Study Design: Retrospective cohort study comparing Dermamatrix vs. Alloderm. .
Level III - NEUTRAL for Alloderm: This study demonstrated no significant differences in the rate of complications or material compliance. The total complication rate was 4 percent, with seroma and wound infection being the most common complications. The authors' preliminary findings indicate no significant difference between implant / expander-based reconstructions using AlloDerm and those using DermaMatrix.

2. The influence of AlloDerm on expander dynamics and complications in the setting of immediate tissue expander/implant reconstruction: a matched-cohort study.
Preminger BA, McCarthy CM, Hu QY, Mehrara BJ, Disa JJ.
Ann Plast Surg. 2008 May;60(5):510-3
Study Design: Retrospective cohort study
Level III - NEUTRAL for Alloderm: Intraoperatively, expanders in the AlloDerm and non-AlloDerm cohorts were filled to a mean volume of 223.8 and 201.1 mL (P = 0.180). Median number of expansions performed was 5 and 6 in the AlloDerm and non-AlloDerm cohorts (P = 0.117). There was no difference in the mean rate of postoperative tissue expansion (AlloDerm: 97 mL/injection versus non-AlloDerm: 95 mL/injection [P = 0.907]), nor in the incidence of complications (P = 0.289). Minor complications occurred in 13.1% of AlloDerm cases (cellulitis [n = 3], seroma [n = 3], hematoma [n = 1]. Although this study does not address AlloDerm's efficacy in decreasing morbidity or improving esthetic outcomes in TE/I reconstruction, it indicates that AlloDerm does not increase the rate of tissue expansion after immediate TE placement. It does not, however, appear to increase the risk of postoperative complications.