06 — References & Evidence

Educational work by a pre-medical student — not medical advice. Not a clinical protocol, prescription, or patient handout, and not for patient care. See DISCLAIMER.

Post-mastectomy breast implant revision — November 2026

Filename note: the historical filename (…_Breast_Augmentation) is kept so existing links keep working. The repository covers implant revision and reconstruction after mastectomy, not cosmetic augmentation.

Purpose and method

This file lists the evidence behind the modules. Dose sources are kept separately in DOSING_SOURCES.md. Every dose, rate, maximum, interval or threshold in the modules is tagged to that registry, and only guidelines and consensus statements, FDA labels and score-validation papers are accepted there.

The work is a narrative synthesis, not a systematic review. No protocol was registered, no systematic search was run, and no formal risk-of-bias assessment was done. The certainty labels in §9 are the author's GRADE-style judgments, not formal GRADE evidence profiles.

Citation audit (v2.0, November 2026). The v1.0 reference list was checked item by item against PubMed, publisher and repository records:

• 14 of 24 v1.0 entries could not be matched to any published article and were removed.
• 9 pointed to real papers or guidelines but had the wrong year, journal, title or edition. They are corrected below. One of these, "Adams WP et al., PRS 2020," matches no paper and was replaced with Adams's actual 2000, 2001 and 2006 papers.
• 1 (Apfel 1999) was correct apart from a missing year.
• Where a DOI or PMID could not be confirmed from a primary record, it is left out.

November 2026 update. Current guidelines were added: the fifth PONV consensus (23a), the 2026 ASA local/regional guideline (9a), the ASRA ketamine consensus (18a), the STOP-Bang and Aldrete validation papers (28a–c), the ASA monitoring standard (28d) and the CDC 2022 opioid guideline (28e). Kopp 2025 (ASRA antithrombotic, fifth edition) is the operative antithrombotic guideline. The removed references are listed in §10 for transparency.

1. Regional anesthesia for breast surgery

1. Blanco R. The 'pecs block': a novel technique for providing analgesia after breast surgery. Anaesthesia. 2011;66(9):847-848. doi:10.1111/j.1365-2044.2011.06838.x. PMID 21831090
2. Blanco R, Fajardo M, Parras Maldonado T. Ultrasound description of Pecs II (modified Pecs I): a novel approach to breast surgery. Rev Esp Anestesiol Reanim. 2012;59(9):470-475. doi:10.1016/j.redar.2012.07.003. PMID 22939099
3. Blanco R, Parras T, McDonnell JG, Prats-Galino A. Serratus plane block: a novel ultrasound-guided thoracic wall nerve block. Anaesthesia. 2013;68(11):1107-1113. doi:10.1111/anae.12344. PMID 23923989
4. Hussain N, Brull R, McCartney CJL, et al. Pectoralis-II myofascial block and analgesia in breast cancer surgery: a systematic review and meta-analysis. Anesthesiology. 2019;131(3):630-648. doi:10.1097/ALN.0000000000002822
5. Grape S, Jaunin E, El-Boghdadly K, Chan V, Albrecht E. Analgesic efficacy of PECS and serratus plane blocks after breast surgery: a systematic review, meta-analysis and trial sequential analysis. J Clin Anesth. 2020;63:109744. doi:10.1016/j.jclinane.2020.109744
6. Aarab Y, et al. Pectoral nerve blocks for breast augmentation surgery: a randomized, double-blind, dual-centered controlled trial. Anesthesiology. 2021;135(3):442-453. doi:10.1097/ALN.0000000000003855
7. Kopp SL, Vandermeulen E, McBane RD, Perlas A, Leffert L, Horlocker T. Regional anesthesia in the patient receiving antithrombotic or thrombolytic therapy: American Society of Regional Anesthesia and Pain Medicine evidence-based guidelines (fifth edition). Reg Anesth Pain Med. 2025. doi:10.1136/rapm-2024-105766. PMID 39880411. (Supersedes the 2018 fourth edition.)
8. Neal JM, Barrington MJ, Fettiplace MR, et al. The third American Society of Regional Anesthesia and Pain Medicine practice advisory on local anesthetic systemic toxicity: executive summary 2017. Reg Anesth Pain Med. 2018;43(2):113-123. doi:10.1097/AAP.0000000000000720. PMID 29356773
9. Neal JM, Neal EJ, Weinberg GL. American Society of Regional Anesthesia and Pain Medicine local anesthetic systemic toxicity checklist: 2020 version. Reg Anesth Pain Med. 2021;46(1):81-82.

9a. Joshi GP, et al. 2026 American Society of Anesthesiologists practice guideline on perioperative pain management using local and regional analgesia for cardiothoracic surgeries, mastectomy, and abdominal surgeries. Anesthesiology. 2026;144:19-43. doi:10.1097/ALN.0000000000005790. PMID 41363869.

Summary. PECS I/II and serratus plane blocks reduce early postoperative pain and opioid consumption after breast surgery compared with no block (refs 4–6). The effect is largest in the first hours, and the trials are heterogeneous. The 2026 ASA guideline (ref 9a) addresses fascial plane blocks for mastectomy. It does not address implant revision specifically, and its Task Force notes the evidence has low methodologic quality. v2.0 removed the v1.0 claims that PECS is "superior to paravertebral" and that perineural dexamethasone adds a fixed number of hours; neither was supported by a cited source for fascial-plane blocks.

2. Opioid-free and multimodal general anesthesia

1. Beloeil H, Garot M, Lebuffe G, et al. Balanced opioid-free anesthesia with dexmedetomidine versus balanced anesthesia with remifentanil for major or intermediate noncardiac surgery: the POFA randomized clinical trial. Anesthesiology. 2021;134(4):541-551. doi:10.1097/ALN.0000000000003725. PMID 33630043
2. Frauenknecht J, Kirkham KR, Jacot-Guillarmod A, Albrecht E. Analgesic impact of intra-operative opioids vs. opioid-free anaesthesia: a systematic review and meta-analysis. Anaesthesia. 2019;74(5):651-662. doi:10.1111/anae.14582. PMID 30802933
3. Salomé A, Harkouk H, Fletcher D, Martinez V. Opioid-free anesthesia benefit–risk balance: a systematic review and meta-analysis of randomized controlled trials. J Clin Med. 2021;10(10):2069. doi:10.3390/jcm10102069
4. Beloeil H. Opioid-free anesthesia. Best Pract Res Clin Anaesthesiol. 2019;33(3):353-360. doi:10.1016/j.bpa.2019.09.002
5. Weerink MAS, Struys MMRF, Hannivoort LN, Barends CRM, Absalom AR, Colin P. Clinical pharmacokinetics and pharmacodynamics of dexmedetomidine. Clin Pharmacokinet. 2017;56(8):893-913. doi:10.1007/s40262-017-0507-7. PMID 28105598
6. McCarthy GC, Megalla SA, Habib AS. Impact of intravenous lidocaine infusion on postoperative analgesia and recovery from surgery: a systematic review of randomized controlled trials. Drugs. 2010;70(9):1149-1163. doi:10.2165/10898560-000000000-00000
7. Weibel S, Jelting Y, Pace NL, et al. Continuous intravenous perioperative lidocaine infusion for postoperative pain and recovery in adults. Cochrane Database Syst Rev. 2018;6:CD009642. doi:10.1002/14651858.CD009642.pub3. PMID 29864216
8. Foo I, Macfarlane AJR, Srivastava D, et al. The use of intravenous lidocaine for postoperative pain and recovery: international consensus statement on efficacy and safety. Anaesthesia. 2021;76(2):238-250. doi:10.1111/anae.15270. PMID 33141959
9. Brinck ECV, Tiippana E, Heesen M, et al. Perioperative intravenous ketamine for acute postoperative pain in adults. Cochrane Database Syst Rev. 2018;12:CD012033. doi:10.1002/14651858.CD012033.pub4

18a. Schwenk ES, Viscusi ER, Buvanendran A, et al. Consensus guidelines on the use of intravenous ketamine infusions for acute pain management from the American Society of Regional Anesthesia and Pain Medicine, the American Academy of Pain Medicine, and the American Society of Anesthesiologists. Reg Anesth Pain Med. 2018;43(5):456-466. doi:10.1097/AAP.0000000000000806. PMID 29870457.

1. Verret M, Lauzier F, Zarychanski R, et al. Perioperative use of gabapentinoids for the management of postoperative acute pain: a systematic review and meta-analysis. Anesthesiology. 2020;133(2):265-279. doi:10.1097/ALN.0000000000003428. PMID 32667154
2. Kharasch ED, Clark JD, Kheterpal S. Perioperative gabapentinoids: deflating the bubble. Anesthesiology. 2020;133(2):251-254. doi:10.1097/ALN.0000000000003394. PMID 32667153

Summary. Compared with opioid-inclusive anesthesia, opioid-free anesthesia gives similar early pain scores and less PONV (ref 11). In the largest multicenter RCT, dexmedetomidine-based OFA had more of the composite adverse outcome (78% vs 67%, driven by hypoxemia) and 5 cases of severe bradycardia, and the trial was stopped early; PONV and opioid use were lower (ref 10). v2.0 removed the v1.0 consensus statement that OFA works "without compromising hemodynamics." For IV lidocaine, the consensus is ≤1.5 mg/kg/h on ideal body weight, ≤24 h, and not concurrently with other local-anesthetic interventions (ref 17; S1). Routine gabapentinoids are not supported (refs 19–20).

3. Guidelines (ERAS, PROSPECT, PONV, NMB, PACU, antibiotics)

1. Temple-Oberle C, Shea-Budgell MA, Tan M, et al. Consensus review of optimal perioperative care in breast reconstruction: Enhanced Recovery after Surgery (ERAS) Society recommendations. Plast Reconstr Surg. 2017;139(5):1056e-1071e. doi:10.1097/PRS.0000000000003242. PMID 28445352
2. Jacobs A, Lemoine A, Joshi GP, Van de Velde M, Bonnet F; PROSPECT Working Group. PROSPECT guideline for oncological breast surgery: a systematic review and procedure-specific postoperative pain management recommendations. Anaesthesia. 2020;75(5):664-673. doi:10.1111/anae.14964. PMID 31984479
3. Gan TJ, Belani KG, Bergese S, et al. Fourth consensus guidelines for the management of postoperative nausea and vomiting. Anesth Analg. 2020;131(2):411-448. doi:10.1213/ANE.0000000000004833. PMID 32467512. (Historical; partly superseded by ref 23a. Retained because its dose table is cited in DOSING_SOURCES.md.)

23a. Gan TJ, et al. Fifth consensus guidelines for the management of postoperative nausea and vomiting: executive summary. Anesth Analg. Published online November 14, 2025. doi:10.1213/ANE.0000000000007816. (PMID: identifier unverified.)

1. Apfel CC, Läärä E, Koivuranta M, Greim CA, Roewer N. A simplified risk score for predicting postoperative nausea and vomiting: conclusions from cross-validations between two centers. Anesthesiology. 1999;91(3):693-700. doi:10.1097/00000542-199909000-00022. PMID 10485781
2. Apfel CC, Korttila K, Abdalla M, et al. A factorial trial of six interventions for the prevention of postoperative nausea and vomiting. N Engl J Med. 2004;350(24):2441-2451.
3. Thilen SR, Weigel WA, Todd MM, et al. 2023 American Society of Anesthesiologists practice guidelines for monitoring and antagonism of neuromuscular blockade. Anesthesiology. 2023;138(1):13-41. doi:10.1097/ALN.0000000000004379. PMID 36520073
4. Apfelbaum JL, Silverstein JH, Chung FF, et al. Practice guidelines for postanesthetic care: an updated report by the American Society of Anesthesiologists Task Force on Postanesthetic Care. Anesthesiology. 2013;118(2):291-307. doi:10.1097/ALN.0b013e31827773e9. PMID 23364567
5. Bratzler DW, Dellinger EP, Olsen KM, et al. Clinical practice guidelines for antimicrobial prophylaxis in surgery. Am J Health Syst Pharm. 2013;70(3):195-283. PMID 23327981. (Also published in Surg Infect (Larchmt). 2013;14(1):73-156; DOI not re-verified in November 2026.)

28a. Chung F, Yegneswaran B, Liao P, et al. STOP questionnaire: a tool to screen patients for obstructive sleep apnea. Anesthesiology. 2008;108(5):812-821. PMID 18431116.

28b. Chung F, Abdullah HR, Liao P. STOP-Bang questionnaire: a practical approach to screen for obstructive sleep apnea. Chest. 2016;149(3):631-638. PMID 26378880.

28c. Aldrete JA. The post-anesthesia recovery score revisited. J Clin Anesth. 1995;7(1):89-91. PMID 7772368.

28d. American Society of Anesthesiologists. Standards for Basic Anesthetic Monitoring (last amended October 15, 2025). https://www.asahq.org/standards-and-practice-parameters/standards-for-basic-anesthetic-monitoring

28e. Dowell D, Ragan KR, Jones CM, Baldwin GT, Chou R. CDC Clinical Practice Guideline for Prescribing Opioids for Pain — United States, 2022. MMWR Recomm Rep. 2022;71(No. RR-3):1-95. doi:10.15585/mmwr.rr7103a1.

Notes on guideline currency.

• PONV: the fifth consensus (ref 23a) recommends two prophylactic interventions for adults at risk. This repository's agent counts (two for 1–2 Apfel factors, three to four for ≥3; S7) follow the fourth consensus algorithm (ref 23), which secondary summaries indicate the fifth retains for higher-risk adults. The fifth's full dose table was not reviewed in November 2026.
• No 2020 or 2023 update of the ERAS breast reconstruction guideline was found. The 2017 paper (ref 21) is the operative document, although an ERAS Society check is still advisable.
• PROSPECT 2020 (ref 22) recommended preoperative gabapentinoids. That recommendation conflicts with the later evidence in refs 19–20, which this repository follows. An updated PROSPECT review for major oncological breast surgery was published online in Anaesthesia in August 2026 (Desai et al., doi:10.1111/anae.70313). Its recommendations have not yet been reviewed for this repository.
• The current ASA postanesthetic care guideline is the 2013 report (ref 27). The "2022" ASA guideline cited in v1.0 does not exist.

4. Implant revision, capsular contracture, and no-touch technique

1. Spear SL, Baker JL Jr. Classification of capsular contracture after prosthetic breast reconstruction. Plast Reconstr Surg. 1995;96(5):1119-1123.
2. Headon H, Kasem A, Mokbel K. Capsular contracture after breast augmentation: an update for clinical practice. Arch Plast Surg. 2015;42(5):532-543. doi:10.5999/aps.2015.42.5.532. PMID 26430623
3. Morkuzu S, Ozdemir M, Leach GA, Kanapathy M, Mosahebi A, Reid CM. Keller funnel efficacy in "no touch" breast augmentation and reconstruction: a systematic review. Plast Reconstr Surg Glob Open. 2022;10(11):e4676. doi:10.1097/GOX.0000000000004676. PMID 36448016
4. Hillard C, Fowler JD, Barta R, Cunningham B. Silicone breast implant rupture: a review. Gland Surg. 2017;6(2):163-168.
5. Spear SL, Seruya M. Management of the infected or exposed breast prosthesis: a single surgeon's 15-year experience with 69 patients. Plast Reconstr Surg. 2010;125(4):1074-1084. doi:10.1097/PRS.0b013e3181d17fff

Summary. v1.0 stated that "increasing evidence supports selective capsulectomy." No cited source supports that statement, so it is now marked as expert-opinion level pending a sourced review.

5. Infection prevention, irrigation, and biofilm

1. Adams WP Jr, Conner WC, Barton FE Jr, Rohrich RJ. Optimizing breast pocket irrigation: an in vitro study and clinical implications. Plast Reconstr Surg. 2000;105(1):334-338.
2. Adams WP Jr, et al. Optimizing breast-pocket irrigation: the post-betadine era. Plast Reconstr Surg. 2001;107(6):1596-1601.
3. Adams WP Jr, Rios JL, Smith SJ. Enhancing patient outcomes in aesthetic and reconstructive breast surgery using triple antibiotic breast irrigation: six-year prospective clinical study. Plast Reconstr Surg. 2006;117(1):30-36.
4. Jewell ML, Bionda N, Moran AV, et al. In vitro evaluation of common antimicrobial solutions used for breast pocket irrigation—Part 2: efficacy against biofilm-associated bacteria. Aesthet Surg J. 2021;41(11):1252-1262. doi:10.1093/asj/sjaa308 (Part 1, planktonic bacteria: doi:10.1093/asj/sjaa309)
5. Deva AK, Adams WP Jr, Vickery K. The role of bacterial biofilms in device-associated infection. Plast Reconstr Surg. 2013;132(5):1319-1328. doi:10.1097/PRS.0b013e3182a3c105
6. Adams WP Jr, Culbertson EJ, Deva AK, et al. Macrotextured breast implants with defined steps to minimize bacterial contamination around the device: experience in 42,000 implants. Plast Reconstr Surg. 2017;140(3):427-431. doi:10.1097/PRS.0000000000003575. PMID 28841597
7. US Food and Drug Administration. FDA requests withdrawal of bacitracin for injection from market. January 31, 2020. https://www.fda.gov/drugs/drug-safety-and-availability/fda-requests-withdrawal-bacitracin-injection-market

Summary.

• The historical Adams triple-antibiotic solution (refs 35–36) is described here as history only. Its recipe is no longer given in the modules. Primary studies are not an acceptable dose source under this repository's dosing-source rules, and injectable bacitracin is withdrawn in the U.S.
• Injectable bacitracin has been off the U.S. market since the FDA's 2020 request (ref 40; S38).
• In vitro, povidone-iodine–containing solutions outperformed triple-antibiotic solution and saline (ref 37).
• The clinical evidence is mostly observational (ref 36), so certainty is low.

6. Implant regulation and patient communication

1. US Food and Drug Administration. Breast Implants – Certain Labeling Recommendations to Improve Patient Communication: Guidance for Industry and FDA Staff. September 2020 (Docket FDA-2019-D-4467). https://www.fda.gov/regulatory-information/search-fda-guidance-documents/breast-implants-certain-labeling-recommendations-improve-patient-communication

On October 27, 2021 S39, FDA approved updated labeling: a boxed warning, a Patient Decision Checklist, and rupture-screening recommendations. FDA also restricted sale to providers who review the checklist with patients. This is why the pre-op checklist and counseling script reference the checklist.

7. Drains and seroma

v1.0 cited two drain and seroma papers (Sbitany 2021; Barry 2022). Neither could be located, and both were removed. The drain criteria in 04 and 05 are surgeon-consensus / expert-opinion level until sourced.

8. Airway

The v1.0 statements that an LMA is "safe for most elective breast surgeries" and that an ETT is preferred for long or complex cases reflect common practice, but no source is cited for them. They are presented as practice heuristics.

9. Summary of evidence certainty (author's judgment)

10. Removed v1.0 references (could not be located)

Abdallah FW et al., Anesthesiology 2021; Kim DH et al., RAPM 2020; Jonkman K et al., BJA 2021; Beloeil H, Curr Opin Anaesthesiol 2020; Spear SL et al., PRS 2020; Adams WP, Clin Plast Surg 2021; Rinker B et al., PRS GO 2022; Moyer HR, PRS 2021; Adams WP et al., PRS 2020; Phillips BT et al., PRS GO 2022; Caffee HH, ASJ 2020; Alperovich M, PRS 2021; Sbitany H, PRS 2021; Barry M, Ann Plast Surg 2022; Habib AS, BJA 2022. Also removed: guideline citations that do not exist, namely "ERAS breast reconstruction 2020/2023 updates," "PROSPECT 2022," "ASA … 2022," and, in Protocol 3, "ASA postoperative pain 2023," "ERAS breast surgery 2023–24," and "ASRA pain 2023."

The first 15 names are the 14 unmatched journal entries plus the nonexistent Adams 2020 entry.

11. Evidence statements not retained

The following are not retained, because a general guideline label cannot establish them and they need source-specific assessment:

• universal superiority of PECS blocks;
• universal safety or superiority of opioid-free anesthesia;
• fixed percentage improvements;
• informal A/B certainty grades;
• claims of consensus for specific irrigation or capsulectomy strategies.

For a separate narrative review with a broader bibliography, see the Breast Reconstruction Analgesia Review. That project is not an institutional protocol either.

Educational resource only. Not a substitute for institutional protocols or professional clinical judgment. Author: Collin B. George, pre-medical student.