Response to the National Consensus on Mastitis: A Self-Serving Consensus with little Clinical Usefulness
Abstract
It is advisable to have consensus guidelines for the prevention and management of mastitis. However, this consensus presents ethical problems and a lack of scientific evidence for some of the recommendations, making its validity and usefulness in clinical practice limited and questionable.
There is insufficient scientific evidence to support considering subacute mastitis as a specific clinical entity, nor the role of bacterial biofilm formation in the mammary ducts and dysbiosis in the development of mastitis. Subclinical mastitis is a term of veterinary origin about which there is very little literature in women, and with highly disparate definitions.
The recommendation for the use of probiotics in the treatment and prevention of mastitis also lacks scientific evidence, being based on very few studies and with a clear conflict of interest among the authors.
Furthermore, the document does not provide information on the identity of the authors who are part of the expert committee, nor on their possible conflicts of interest, nor on the source of funding for the committee. Several members of the scientific committee are affiliated with the Danone Institute, the company sponsoring the consensus and the marketer of one of the recommended probiotics.
In short, this is a document that could have a significant impact on clinical practice were it not for the fact that its findings are completely undermined by the scant scientific evidence it provides and the undeniable role that the industry, with its clear economic interests, has played in its development.
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1. Álvarez Calatayud G, González Hernández C, Blesa Baviera LC, Cancelo Hidalgo MJ, Leis Trabazo R, Moreno Villares JM, et al. Consenso Nacional en Mastitis. Barcelona: Instituto Danone; 2025. ISBN: 978-84-18836-16-9.
2. Baeza C, Paricio-Talayero JM, Pina M, De Alba C. Re: «Academy of Breastfeeding Medicine Clinical Protocol #36: the Mastitis Spectrum, revised 2022» by Mitchell et al. Breastfeed Med. 2022;17(11):970-1. https://doi.org/10.1089/bfm.2022.0129
3. Carrera M, Arroyo R, Mediano P, Fernández L, Marín M, Rodríguez JM. Lactancia materna y mastitis. Tratamiento empírico basado en la sintomatología y los agentes etiológicos. Acta Pediatr Esp. 2012;70(6):255-61.
4. Arroyo R, Martín V, Maldonado A, Jiménez E, Fernández L, Rodríguez JM. Treatment of infectious mastitis during lactation: antibiotics versus oral administration of lactobacilli isolated from breast milk. Clin Infect Dis. 2010;50(12):1551-8. https://doi.org/10.1086/652763
5. Fernández L, Rodríguez JM. Mastitis. El lado oscuro de la lactancia. Microbiota mamaria: de la fisiología a las mastitis. Edición especial para Angelini Farmacéutica SL. Probiosearch; 2013.
6. Jiménez E, De Andrés J, Manrique M, Pareja-Tobes P, Tobes R, Martínez-Blanch JF, et al. Metagenomic analysis of milk of healthy and mastitis-suffering women. J Hum Lact. 2015;31(3):406-15. https://doi.org/10.1177/0890334415585078
7. Fernández L, Cárdenas N, Arroyo R, Manzano S, Jiménez E, Martín V, Rodríguez JM. Prevention of infectious mastitis by oral administration of Lactobacillus salivarius PS2 during late pregnancy. Clin Infect Dis. 2016;62(5):568-73. https://doi.org/10.1093/cid/civ974
8. Mediano P, Fernández L, Jiménez E, Arroyo R, Espinosa-Martos I, Rodríguez JM, Marín M. Microbial diversity in milk of women with mastitis: potential role of coagulase-negative staphylococci, viridans group streptococci, and corynebacteria. J Hum Lact. 2017;33(2):309-18. https://doi.org/10.1177/0890334417692968
9. Patel SH, Vaidya YH, Patel RJ, et al. Culture independent assessment of human milk microbial community in lactational mastitis. Sci Rep. 2017;7:7804. https://doi.org/10.1038/s41598-017-08451-7
10. Sociedad Española de Ginecología y Obstetricia. Infecciones de la mama relacionadas con la lactancia. Prog Obstet Ginecol. 2019;62(3):511-23. https://doi.org/10.20960/j.pog.00239
11. Boix-Amorós A, Hernández-Aguilar MT, Artacho A, et al. Human milk microbiota in sub-acute lactational mastitis induces inflammation and undergoes changes in composition, diversity and load. Sci Rep. 2020;10:18521. https://doi.org/10.1038/s41598-020-74719-0
12. Betts RC, Johnson HM, Eglash A, Mitchell KB. It’s not yeast: retrospective cohort study of lactating women with persistent nipple and breast pain. Breastfeed Med. 2021;16(4):318-24. https://doi.org/10.1089/bfm.2020.0160
13. Mitchell KB, Johnson HM, Rodríguez JM, Eglash A, Scherzinger C, Zakarija-Grkovic I, et al. Academy of Breastfeeding Medicine Clinical Protocol #36: The Mastitis Spectrum, revised 2022. Breastfeed Med. 2022;17(5):360-76.
14. Mitchell KB, Johnson HM. Breast conditions in the breastfeeding mother. En: Lawrence RA, Lawrence RM, editors. Breastfeeding: A Guide for the Medical Profession. 9th ed. Elsevier; 2022. p. 572-93. https://doi.org/10.1016/B978-0-323-68013-4.00016-X
15. Quifer-Rada P, Aguilar-Camprubí L, Samino S, Amigó N, Soler O, Padró-Arocas A. Metabolomics approach to identify biomarkers of acute and subacute mastitis in milk samples: a pilot case-control study. Metabolites. 2024;14(10):566. https://doi.org/10.3390/metabo14100566
16. Douglas P. Re-thinking benign inflammation of the lactating breast: a mechanobiological model. Womens Health (Lond). 2022;18:17455065221075907. https://doi.org/10.1177/17455065221075907
17. Kvist LJ. Diagnostic methods for mastitis in cows are not appropriate for use in humans: commentary. Int Breastfeed J. 2016;11:2. https://doi.org/10.1186/s13006-016-0061-1
18. Douglas P. Does the Academy of Breastfeeding Medicine’s Clinical Protocol #36 promote overtreatment and risk worsened outcomes for breastfeeding families? Commentary. Int Breastfeed J. 2023;18(1):51. https://doi.org/10.1186/s13006-023-00588-8
19. Gomo E, Filteau SM, Tomkins AM, Ndhlovu P, Michaelsen KF, Friis H. Subclinical mastitis among HIV-infected and uninfected Zimbabwean women. Trans R Soc Trop Med Hyg. 2003;97(2):212-16. https://doi.org/10.1016/S0035-9203(03)90124-6
20. Samuel TM, De Castro CA, Dubascoux S, Affolter M, Giuffrida F, Billeaud C, et al. Subclinical mastitis in a European multicenter cohort. Nutrients. 2020;12(1):105. https://doi.org/10.3390/nu12010105
21. Pace RM, Pace CDW, Fehrenkamp BD, Price WJ, Lewis M, Williams JE, et al. Sodium and potassium concentrations and somatic cell count as biomarkers of mastitis. Nutrients. 2022;14(22):4708. https://doi.org/10.3390/nu14224708
22. Angelopoulou A, Harris HMB, Warda AK, et al. Somatic cell count as an indicator of subclinical mastitis. Microbiol Spectr. 2024;12(10):e0405123. https://doi.org/10.1128/spectrum.04051-23
23. Castro-Navarro I, Pace RM, Williams JE, Pace CDW, Kaur H, Piaskowski J, et al. Immunological composition of human milk before and during mastitis. Front Immunol. 2025;15:1532432. https://doi.org/10.3389/fimmu.2024.1532432
24. Wren-Atilola HM, Solomons NW, Scott ME, Koski KG. Infant growth faltering linked to subclinical mastitis. Matern Child Nutr. 2019;15(3):e12756. https://doi.org/10.1111/mcn.12756
25. Aryeetey RN, Marquis GS, Brakohiapa L, Timms L, Lartey A. Subclinical mastitis may not reduce breastmilk intake. Breastfeed Med. 2009;4(3):161-6. https://doi.org/10.1089/bfm.2008.0131
26. Crepinsek MA, Taylor EA, Michener K, Stewart F. Interventions for preventing mastitis after childbirth. Cochrane Database Syst Rev. 2020;9:CD007239.
27. Yu Q, Xu C, Wang M, Zhu J, Yu L, Yang Z, et al. Preventive and therapeutic effects of probiotics on mastitis: systematic review and meta-analysis. PLoS One. 2022;17(9):e0274467.
28. Hurtado JA, Maldonado-Lobón JA, Díaz-Ropero MP, Flores-Rojas K, Uberos J, Leante JL, et al. Oral administration of Lactobacillus fermentum CECT5716 prevents lactational mastitis. Breastfeed Med. 2017;12(4):202-9. https://doi.org/10.1089/bfm.2016.0173
29. Jiménez E, Manzano S, Schlembach D, Arciszewski K, Martin R, Ben Amor K, et al. Ligilactobacillus salivarius PS2 supplementation prevents mastitis. Microorganisms. 2021;9(9):1933. https://doi.org/10.3390/microorganisms9091933
30. Barker M, Adelson P, Peters MDJ, Steen M. Probiotics and human lactational mastitis: a scoping review. Women Birth. 2020;33(6):e483-e491.
31. Morcomb EF, Dargel CM, Anderson SA. Mastitis: rapid evidence review. Am Fam Physician. 2024;110(2):174-82.
32. Espínola-Docio B, Costa-Romero M, Díaz-Gómez NM, Paricio-Talayero JM, Comité de Lactancia Materna AEP. Mastitis. Puesta al día. Arch Argent Pediatr. 2016;114(6):576-84.
33. Amir LH, Griffin L, Cullinane M, Garland SM. Probiotics and mastitis: evidence-based marketing? Int Breastfeed J. 2016;11:19. https://doi.org/10.1186/s13006-016-0078-5
34. EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA). Lactobacillus fermentum CECT 5716 and reduction of staphylococcus load in breast milk. EFSA J. 2017;15(7):e04917. https://doi.org/10.2903/j.efsa.2017.4917
35. Eglash A, Plane MB, Mundt M. Clinical outcomes of lactating women treated with antibiotics for chronic breast pain. J Hum Lact. 2006;22(4):429-33. https://doi.org/10.1177/0890334406293431
36. Kvist LJ, Larsson BW, Hall-Lord ML, Steen A, Schalén C. Role of bacteria in lactational mastitis. Int Breastfeed J. 2008;3:6. https://doi.org/10.1186/1746-4358-3-6
37. Perales Palacios I. Diagnóstico microbiológico de mastitis. Enferm Infecc Microbiol Clin. 2016;34(10):692-3.
38. Rimoldi SG, Pileri P, Mazzocco MI, et al. The role of Staphylococcus aureus in mastitis. J Hum Lact. 2020;36(3):503-9. https://doi.org/10.1177/0890334419876272
39. Witt A, Mason MJ, Burgess K, Flocke S, Zyzanski S. Bacterial species and colony count in milk of women with chronic pain. Breastfeed Med. 2014;9(1):29-34. https://doi.org/10.1089/bfm.2013.0012
2. Baeza C, Paricio-Talayero JM, Pina M, De Alba C. Re: «Academy of Breastfeeding Medicine Clinical Protocol #36: the Mastitis Spectrum, revised 2022» by Mitchell et al. Breastfeed Med. 2022;17(11):970-1. https://doi.org/10.1089/bfm.2022.0129
3. Carrera M, Arroyo R, Mediano P, Fernández L, Marín M, Rodríguez JM. Lactancia materna y mastitis. Tratamiento empírico basado en la sintomatología y los agentes etiológicos. Acta Pediatr Esp. 2012;70(6):255-61.
4. Arroyo R, Martín V, Maldonado A, Jiménez E, Fernández L, Rodríguez JM. Treatment of infectious mastitis during lactation: antibiotics versus oral administration of lactobacilli isolated from breast milk. Clin Infect Dis. 2010;50(12):1551-8. https://doi.org/10.1086/652763
5. Fernández L, Rodríguez JM. Mastitis. El lado oscuro de la lactancia. Microbiota mamaria: de la fisiología a las mastitis. Edición especial para Angelini Farmacéutica SL. Probiosearch; 2013.
6. Jiménez E, De Andrés J, Manrique M, Pareja-Tobes P, Tobes R, Martínez-Blanch JF, et al. Metagenomic analysis of milk of healthy and mastitis-suffering women. J Hum Lact. 2015;31(3):406-15. https://doi.org/10.1177/0890334415585078
7. Fernández L, Cárdenas N, Arroyo R, Manzano S, Jiménez E, Martín V, Rodríguez JM. Prevention of infectious mastitis by oral administration of Lactobacillus salivarius PS2 during late pregnancy. Clin Infect Dis. 2016;62(5):568-73. https://doi.org/10.1093/cid/civ974
8. Mediano P, Fernández L, Jiménez E, Arroyo R, Espinosa-Martos I, Rodríguez JM, Marín M. Microbial diversity in milk of women with mastitis: potential role of coagulase-negative staphylococci, viridans group streptococci, and corynebacteria. J Hum Lact. 2017;33(2):309-18. https://doi.org/10.1177/0890334417692968
9. Patel SH, Vaidya YH, Patel RJ, et al. Culture independent assessment of human milk microbial community in lactational mastitis. Sci Rep. 2017;7:7804. https://doi.org/10.1038/s41598-017-08451-7
10. Sociedad Española de Ginecología y Obstetricia. Infecciones de la mama relacionadas con la lactancia. Prog Obstet Ginecol. 2019;62(3):511-23. https://doi.org/10.20960/j.pog.00239
11. Boix-Amorós A, Hernández-Aguilar MT, Artacho A, et al. Human milk microbiota in sub-acute lactational mastitis induces inflammation and undergoes changes in composition, diversity and load. Sci Rep. 2020;10:18521. https://doi.org/10.1038/s41598-020-74719-0
12. Betts RC, Johnson HM, Eglash A, Mitchell KB. It’s not yeast: retrospective cohort study of lactating women with persistent nipple and breast pain. Breastfeed Med. 2021;16(4):318-24. https://doi.org/10.1089/bfm.2020.0160
13. Mitchell KB, Johnson HM, Rodríguez JM, Eglash A, Scherzinger C, Zakarija-Grkovic I, et al. Academy of Breastfeeding Medicine Clinical Protocol #36: The Mastitis Spectrum, revised 2022. Breastfeed Med. 2022;17(5):360-76.
14. Mitchell KB, Johnson HM. Breast conditions in the breastfeeding mother. En: Lawrence RA, Lawrence RM, editors. Breastfeeding: A Guide for the Medical Profession. 9th ed. Elsevier; 2022. p. 572-93. https://doi.org/10.1016/B978-0-323-68013-4.00016-X
15. Quifer-Rada P, Aguilar-Camprubí L, Samino S, Amigó N, Soler O, Padró-Arocas A. Metabolomics approach to identify biomarkers of acute and subacute mastitis in milk samples: a pilot case-control study. Metabolites. 2024;14(10):566. https://doi.org/10.3390/metabo14100566
16. Douglas P. Re-thinking benign inflammation of the lactating breast: a mechanobiological model. Womens Health (Lond). 2022;18:17455065221075907. https://doi.org/10.1177/17455065221075907
17. Kvist LJ. Diagnostic methods for mastitis in cows are not appropriate for use in humans: commentary. Int Breastfeed J. 2016;11:2. https://doi.org/10.1186/s13006-016-0061-1
18. Douglas P. Does the Academy of Breastfeeding Medicine’s Clinical Protocol #36 promote overtreatment and risk worsened outcomes for breastfeeding families? Commentary. Int Breastfeed J. 2023;18(1):51. https://doi.org/10.1186/s13006-023-00588-8
19. Gomo E, Filteau SM, Tomkins AM, Ndhlovu P, Michaelsen KF, Friis H. Subclinical mastitis among HIV-infected and uninfected Zimbabwean women. Trans R Soc Trop Med Hyg. 2003;97(2):212-16. https://doi.org/10.1016/S0035-9203(03)90124-6
20. Samuel TM, De Castro CA, Dubascoux S, Affolter M, Giuffrida F, Billeaud C, et al. Subclinical mastitis in a European multicenter cohort. Nutrients. 2020;12(1):105. https://doi.org/10.3390/nu12010105
21. Pace RM, Pace CDW, Fehrenkamp BD, Price WJ, Lewis M, Williams JE, et al. Sodium and potassium concentrations and somatic cell count as biomarkers of mastitis. Nutrients. 2022;14(22):4708. https://doi.org/10.3390/nu14224708
22. Angelopoulou A, Harris HMB, Warda AK, et al. Somatic cell count as an indicator of subclinical mastitis. Microbiol Spectr. 2024;12(10):e0405123. https://doi.org/10.1128/spectrum.04051-23
23. Castro-Navarro I, Pace RM, Williams JE, Pace CDW, Kaur H, Piaskowski J, et al. Immunological composition of human milk before and during mastitis. Front Immunol. 2025;15:1532432. https://doi.org/10.3389/fimmu.2024.1532432
24. Wren-Atilola HM, Solomons NW, Scott ME, Koski KG. Infant growth faltering linked to subclinical mastitis. Matern Child Nutr. 2019;15(3):e12756. https://doi.org/10.1111/mcn.12756
25. Aryeetey RN, Marquis GS, Brakohiapa L, Timms L, Lartey A. Subclinical mastitis may not reduce breastmilk intake. Breastfeed Med. 2009;4(3):161-6. https://doi.org/10.1089/bfm.2008.0131
26. Crepinsek MA, Taylor EA, Michener K, Stewart F. Interventions for preventing mastitis after childbirth. Cochrane Database Syst Rev. 2020;9:CD007239.
27. Yu Q, Xu C, Wang M, Zhu J, Yu L, Yang Z, et al. Preventive and therapeutic effects of probiotics on mastitis: systematic review and meta-analysis. PLoS One. 2022;17(9):e0274467.
28. Hurtado JA, Maldonado-Lobón JA, Díaz-Ropero MP, Flores-Rojas K, Uberos J, Leante JL, et al. Oral administration of Lactobacillus fermentum CECT5716 prevents lactational mastitis. Breastfeed Med. 2017;12(4):202-9. https://doi.org/10.1089/bfm.2016.0173
29. Jiménez E, Manzano S, Schlembach D, Arciszewski K, Martin R, Ben Amor K, et al. Ligilactobacillus salivarius PS2 supplementation prevents mastitis. Microorganisms. 2021;9(9):1933. https://doi.org/10.3390/microorganisms9091933
30. Barker M, Adelson P, Peters MDJ, Steen M. Probiotics and human lactational mastitis: a scoping review. Women Birth. 2020;33(6):e483-e491.
31. Morcomb EF, Dargel CM, Anderson SA. Mastitis: rapid evidence review. Am Fam Physician. 2024;110(2):174-82.
32. Espínola-Docio B, Costa-Romero M, Díaz-Gómez NM, Paricio-Talayero JM, Comité de Lactancia Materna AEP. Mastitis. Puesta al día. Arch Argent Pediatr. 2016;114(6):576-84.
33. Amir LH, Griffin L, Cullinane M, Garland SM. Probiotics and mastitis: evidence-based marketing? Int Breastfeed J. 2016;11:19. https://doi.org/10.1186/s13006-016-0078-5
34. EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA). Lactobacillus fermentum CECT 5716 and reduction of staphylococcus load in breast milk. EFSA J. 2017;15(7):e04917. https://doi.org/10.2903/j.efsa.2017.4917
35. Eglash A, Plane MB, Mundt M. Clinical outcomes of lactating women treated with antibiotics for chronic breast pain. J Hum Lact. 2006;22(4):429-33. https://doi.org/10.1177/0890334406293431
36. Kvist LJ, Larsson BW, Hall-Lord ML, Steen A, Schalén C. Role of bacteria in lactational mastitis. Int Breastfeed J. 2008;3:6. https://doi.org/10.1186/1746-4358-3-6
37. Perales Palacios I. Diagnóstico microbiológico de mastitis. Enferm Infecc Microbiol Clin. 2016;34(10):692-3.
38. Rimoldi SG, Pileri P, Mazzocco MI, et al. The role of Staphylococcus aureus in mastitis. J Hum Lact. 2020;36(3):503-9. https://doi.org/10.1177/0890334419876272
39. Witt A, Mason MJ, Burgess K, Flocke S, Zyzanski S. Bacterial species and colony count in milk of women with chronic pain. Breastfeed Med. 2014;9(1):29-34. https://doi.org/10.1089/bfm.2013.0012
Baeza Pérez-Fontán, C., Paricio-Talayero, J.-M., Días-Gómez, N. M., Espínola-Docio, B., & Costa-Romero, M. (2026). Response to the National Consensus on Mastitis: A Self-Serving Consensus with little Clinical Usefulness. Revista De Lactancia Materna, 4, e34682. https://doi.org/10.14201/rlm.34682
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