Clinical implications of the mechanobiological models of breast and nipple pain: responses to questions. Dr Pamela Douglas, ABM 27th Annual Meeting Baltimore US 1_12_22

1. How do you facilitate frequent milk removal (12 per day per breast) when clients need to pump at work? Most jobs do not facilitate pumping every two hours.

The questioner will be relieved to hear that the NDC approach to frequent and flexible breastfeeding is quite different to a prescription for ‘pumping every two hours’. It is detailed, with its evidence-base, in Table 2 page 4 of my article 'Re-thinking lactation-related breast inflammation: Classification, prevention and management'.

To summarise, the NDC approach to frequent and flexible breastfeeding, the breast is conceptualized as one of ‘two tools’ for dialing a baby down, without pressure being placed on any particular feed-time for milk removal. The other NDC tool for dialing babies down is rich and diverse sensory nourishment. Breastfeeding in the NDC approach is conceptualized not just as caloric nourishment, which occurs in highly variable ways over a 24-hour period, with erratically spaced breastfeeds and highly variable volumes transferred in each breastfeed, but as an important source of sensory-motor nourishment. Power is handed back to the woman as she experiments between these two tools. Multiple concerns that the mother may raise, arising from popular misconceptions, are carefully addressed by an NDC practitioner using a range of verbal ‘scripts’.

The NDC approach to mechanical milk removal may seem quite different to usual routinised pumping recommendations. It aims to optimize milk production and removal by replicating the biological norm as closely as possible, at the same time minimising the occupational fatigue of pumping. The NDC approach places the woman and her baby at the centre of her decision-making, and once she is properly informed about the frequency and durations of milk removal which are typically necessary to maintain supply and infant weight gain, she will decide what is workable for her and her baby as she removes her milk mechanically, including in her paid work situation.

It's vital that workplaces provide safe and private places for lactating woman to pump. In the absence of enforceable regulations protecting her right to pump, I support a woman to be pragmatic, and focus on workability in her own unique context.

2, 3. Thank you Dr. Douglas for your presentation. On slide 28 you state that the 2016 study on Therapeutic Breast Massage had a 70% loss to follow-up in the intervention group and I want to take the time to point out that is not an accurate statement. Actually the intervention group of 42 patients had followup of 90% at 2 days and 98% at 12 weeks. So actually the study has excellent followup. And you mention the 2019 systemic review on the efficacy of breast massage for breastfeeding problems. While the review does note that we need more research it also state: The findings from this review support breast massage in various forms for reducing breast pain; I would appreciate your clarification on your conclusions given this more accurate clarification of these studies.

I am grateful to participants for drawing attention to my misrepresentations of Witt et al (1) follow up numbers, initially in Appendix 1 of my article 'Re-thinking benign lactation-related breast inflammation: classification, prevention, management', and then replicated in my workshop presentation to the Academy of Breastfeeding Medicine’s conference on Slide #28. Follow up in this study was, in fact, excellent. In Appendix 1 of my article, I also wrongly attributed these numbers to the 2019 Anderson et al systematic review, ‘Effectiveness of breast massage for the treatment of women with breastfeeding problems’.(2) I apologise unreservedly for these errors. I’m not sure how it happened. I have published an Erratum for the Women’s Health journal.

Correcting my erroneous representations of the Witt et al follow-up numbers does not alter my conclusion that the use of Therapeutic Breast Massage for lactation-related breast inflammation lacks a credible evidence-base, and lacks credible pathophysiological mechanisms. I have published a corrected, detailed analysis of the Witt et al study and also the Anderson et al systematic review concerning risks associated with Therapeutic Breast Massage here and here.

I appreciate your research and critical consideration of the recent protocol recommendations. I would argue that overall the prominent recommendations to decrease inflammation (cease massage, use of ice/cold, NSAIDS) as well as to decrease use of antibiotics is primarily a benefit.

I detail my concerns about Academy of Breastfeeding Medicine’s Clinical Protocol #36 The mastitis spectrum, and my concerns it may continue to drive unnecessary antibiotic use and also impact negatively upon outcomes for some breastfeeding women, in an article available here.

I agree that not using lump massage is important. My article called ‘Why can’t I massage out my blocked milk ducts or mastitis?’ published in 2021 might be a useful resource.

Coldness has been shown to decrease lactiferous duct diameter(3) and so may decrease milk transfer, which is vital for decreasing breast inflammation - although the baby’s mouth will warm the breast tissue. Warmth applications increase hyperaemia which may worsen inflammation.

I think it unwise to formally recommend either as clinicians, since either may unnecessarily complicate or delay the simple act of bringing the baby to the breast, without benefit. I contend that as breastfeeding medicine physicians and IBCLCs we need to minimize rules and instructions, and prescribe only what is likely to be effective as treatment, behaviourally or medically. Unnecessary rules and instructions by health professionals disempower women.

NSAIDs have a role in comfort but are not curative and should be used judiciously, because of the risk of suppression of the immune response when overused. I discuss this on page 12 of 'Rethinking lactation-related inflammation: classification, prevention and management'.

4B. I also argue that phlegmon is a clinical dx confirmed by u/s in most lactation-related cases in which the dx is made.

On page 8 of 'Re-thinking benign lactation-related inflammation: classification, prevention, management', I point out that the term ‘phlegmon’ lacks clear definition and is extrapolated from the surgical literature, where inflammatory masses referred to as phlegmons may surround a hollow organ, for example, in appendicitis and diverticulitis.

In the lactating breast, a phlegmon has been described clinically as a poorly defined indurated lump, confirmed on ultrasound imaging. I propose that the tissues of the lactating breast are unique and that extrapolation of surgical diagnoses are often quite inappropriate. I propose that we should avoid introducing diagnoses when that diagnosis does not offer demonstrated added benefits.(4) This is because we are treating patients in the context of an international trend more broadly to create new diagnoses which lack benefit to patients, but which drive unnecessary investigations and treatments.

In the NDC approach, which aims to avoid unnecessary diagnoses and treatments, the term phlegmon falls into this category and is not used. Clinically, the presentation of breast inflammation associated with a lump either resolves with conservative treatment, or requires ultrasound imaging in order to exclude abscess. We would expect a spectrum of hyperaemic tissue with interstitial fluid from barely discernible to macroscopic collections to be demonstrated by ultrasound when there is localized clinical inflammation but no abscess formation; phlegmon is a diagnosis applied subjectively without clear definition to the more severe end of this spectrum of inflammation visible on ultrasound. Clinical progression should drive follow-up ultrasound imaging, not a diagnosis of phlegmon, in the absence of abscess. There is no rationale for antibiotic use for an imaging diagnosis of phlegmon, unless signs, symptoms, and duration of the presenting inflammatory lump indicate antibiotic use.

5. Please explain further your statement that "all mastitis involves bacteria." Are you suggesting that there is always bacterial infection?

The immune system of the lactating breast is best understood as multiple interacting complex systems, including the milk microbiome, and its function and components are detailed in my article: Re-thinking benign lactation-related inflammation: a mechanobiological model page 5. In summary, the mammary immune system, and any response to inflammation, triggers downregulatory changes in:

• The woman’s broader immune system

• Her milk, which includes immunomodulatory interactions between the complex systems of the milk microbiome, metabolome, leucocytes, somatic cells

• The leucocytes and epithelial cells in milk

• Epithelial cells of both alveoli and ducts

• Healthy breast stroma appears to contain bacteria.

The human milk microbiome contains at least a couple of hundred species of bacteria (as well as viruses, fungi and other microorganisms).

An inflammatory response in the breast may be subclinical or clinical, and both subclinical and clinical inflammation are part of the mammary immune system response, which aims to downregulate the inflammation. The milk microbiome is dynamic, constantly changing as part of immunoregulatory responses. Any clinically presenting inflammation of the lactating breast (mastitis) will result in compensatory and homeostatic changes in the microbiome. Moreover, pointing to the milk microbiome’s complexity and dynamism, detected changes in the milk microbiome have not been found to be clinically meaningful, including in breast inflammation.

6. Additionally, the protocol's recommendations around frequency seems to be against INCREASING frequency which is a common recommendation from older guidance.

This is a concerning aspect of Clinical Protocol #36, which may risk worsened outcomes for lactating women. I explore my concerns and the evidence that we have in detail here.

7. Sorry if I missed this; can you explain nipple and breast tissue drag?

‘Nipple and breast tissue drag’ is a parent-friendly phrase used when applying the gestalt method of fit and hold. There is a parent-friendly animation about this here, which you’d be welcome to use.

Breast tissue drag refers to the effects of conflicting intra-oral vectors of force during suckling. That is, nipple and breast tissue drag occur in breastfeeding when the vacuum generated by the reflexive drop of the infant’s mandible conflicts with the effects of gravity or other vector of force dragging upon the breast. As a result, a high mechanical stretching force is concentrated on a small part of the nipple epithelium. This concentrated mechanical load of breast tissue drag risks inflammation of the nipple epithelium and stroma, and fracture of the epithelium. This mechanobiological model of nipple pain and damage is fully detailed in my publication 'Re-thinking lactation-related nipple pain and damage'.(5)

With the gestalt method, we aim to eliminate conflicting vectors of force so that the intra-oral vacuum is distributed as evenly as possible over as much of the surface of intra-oral breast tissue as possible, dispersing the mechanical force and minimizing application of the stretching force on any one area of the nipple skin.(6, 7) I and co-authors published a small ultrasound case series earlier this year. It showed that eliminating intra-oral breast tissue drag by applying a brief gestalt intervention in women who continued to have with serious breastfeeding problems despite comprehensive IBCLC intervention had the same effects on ultrasound measures as has been linked elsewhere with less nipple pain and improved milk transfer, and as measured pre- and post-frenotomy in another study. This article details the elements of the gestalt method in detail, with photographic and video illustrations.(8)

8. What do you make of research suggesting asymptomatic inflammation (no clinical symptoms of mastitis) is linked to lower milk supply and nutritional content?

I analyse the research on this topic on page 8-9 of 'Classification, prevention and management'. You’ll find the citations there. In summary, in 2020, Samuel et al diagnosed 40% of 305 breastfeeding mothers at day 2 post-birth with ‘subclinical mastitis’, decreasing to 10% at day 17.(9) Samuel et al applied a milk sodium to potassium ratio greater than 0.6 as diagnostic. They found that their diagnosis of ‘subclinical mastitis’ was associated with lower lactose levels, changes in fatty acid, mineral and trace element composition, and elevated interleukin and inflammatory proteins.

As I argue in 'Classification, prevention and management', Samuel et al do not demonstrate the existence of a clinically relevant diagnosis of subclinical or subacute mastitis. They do however demonstrate that multiple factors related to inflammation are identifiable in human milk, and that subclinical pro-inflammatory feedback loops are normal in the lactating breast. Applying my mechanobiological model, these inflammatory feedback loops downregulate milk secretion within the many complex systems of the lactating breast, affected by both biological and behavioural factors.

The lactating breast is a pro-inflammatory environment. According to the mechanobiological model of breast inflammation, downregulation of supply occurs in response to decreased milk transfer, mediated by the inflammation that occurs when the tight junctions between lactocytes strain and rupture. Alveolar rupture results in a typical microscopic wound-healing inflammatory response, sub-clinically.

9. Could you demonstrate what you mean by "palm" movement of the breast and how this is different from using fingers?

Women might use the whole of their hand to cup and gently move their breasts, without causing pain, particularly if they have a generous breast, when breast inflammation arises. This is not the same as Therapeutic Breast Massage, or Manual Lymphatic Drainage, or lump massage. It does not require referral to a provider. I analyse breast massage in lactation in an article here. Please note that I have used the wrong follow-up numbers for the Witt et al study, which had excellent follow-up, and wrongly attribute this to the Anderson study. I offer an Erratum and apology concerning these errors. I stand by my analysis demonstrating that the Witt et al study does not support the use of Therapeutic Breast Massage in lactation.

10. How many days now for antibiotics for mastitis?

Once the decision is made to commence antibiotics, please consult ABM Clinical Protocol #36 for selection and durations.

11. Galactocele - no redness or fever - how to help resolve?

There is no need to intervene for a galactocoele. A galactocoele is a milk retention cyst, comprised of dilated terminal lactiferous ducts, surrounded by a layer of epithelial cells and myoepithelial cells, containing either milk or, if chronic, semisolid material. Drainage is required if a galactocoele becomes inflamed, at which time it has become an abscess.

12. Pamela, thanks for sharing all your knowledge. I haven´t seen in the managements you have shared with us, the use of hot and cold, and also haven´t seen the use of therapeutic ultrasound. What are your thoughts on these interventions?

Please see Question 4A re hot and cold applications.

I detail the many strategies for management of benign lactation-related breast inflammation which have been demonstrated as ineffective or which lack scientific rationale in Table 3 p 7 'Classification, prevention, management'.

Therapeutic ultrasound (TUS) is the most commonly used intervention for breast inflammation by physiotherapists. There is no evidence to support its use, and no credible pathophysiological rationales for its use. Proponents claim that the acoustic waves disrupt bacterial biofilms, which make antibiotics more effective; that TUS vibrates stromal tissue which is anti-inflammatory, and that it soothes sensory nerves. It is claimed to improve local circulation. I analyse the existing research in the third column of Table 3 p 7 Classification, prevention and management, and also in my article critiquing ABM Clinical Protocol #36.

Women’s anecdotal perception of benefit with TUS is likely to relate to the milk ejections and ductal dilations that result from the movement of the transducer with warm gel. Putting baby on to the breast for a moment, or gentle hand expression, is much cheaper and more convenient way of stimulating ductal dilations.

13. I think it is important and patient-centered to point out that lack of evidence does not equal evidence of harm and that your objections to lymphatic drainage massage are still theoretical. We really need comparative trials on this!

Lack of evidence does not equal evidence of harm. Comparative trials are always welcome! However, if we are to put the precious research dollar into studies that are likely to be useful to breastfeeding women, then we need to be robustly discussing underlying pathophysiological models, to make sure we are only investing into studies which make pathophysiological sense. Robust theoretical frames are foundational in implementation science. There is also evidence more broadly in clinical medicine to suggest that overtreatment in the absence of supportive evidence may cause unexpected and unpredictable harm. Two kinds of negative outcomes often not taken into account are exacerbation of anxiety, and financial burden - for individual families, for health systems, and for equitable international access to healthcare services. Please see my article here for further discussion of why I consider both Therapeutic Breast Massage and Manual Lymphatic Drainage should be avoided in breastfeeding women.

14. So just gentle palm massage for painful blocked ducts?

The primary treatment for painful blocked ducts is frequent flexible milk removal from the affected breast. Principle 5 in the NDC approach to breast inflammation is gentle manual movement of the breast by the woman herself. This is discussed further here.

15. You are recommending frequent removal of the milk with breast swelling. How would you remove milk from a swollen breast without reducing swelling in the first place? Can you please demonstrate hand expression technique that you use? Thank you.

Most forms of breast inflammation are localized. The questioner may be referring to severe engorgement, which may make it more difficult for the baby to come on to the breast and transfer milk. Please see my analysis of why I disagree with Clinical Protocol #36’s advice to cease trying to breastfeed in that case.

16. I may have missed this, it what positioning helps decrease nipple/tissue drag?

Yes, that’s true. Please see Question 7 for further discussion and articles that might be useful.

17. How do you help find comfortable latches for your dyads?

The gestalt method of fit and hold is discussed further in Question 7. This information is available for breastfeeding women in our parent-facing websites, and taught in our Masterclasses and NDC Accreditation pathway possumsonline.com.*

2024 note: Neither of these sites exist anymore, please see ndcinstitute.com.au or drpam.au for our health professional education centre and parent education programs (respectively).

18. Is there a reason that your video doesn't show the tongue 'wave' or peristalsis that has been shown in ultrasound studies? is this intentional?

Yes, that’s because ultrasound studies demonstrate that peristalsis is not part of infant tongue movement during breastfeeding. The anterior and mid-tongue move ‘en bloc’, and the posterior tongue, which is not visible on examination of the infant’s mouth, has some anterior-posterior movement. This is illustrated in the video and animation here.

19. Question about your statements on moist wound healing - it sounds like you promote women leave the bra off and let the nipples dry out? We know that skin wounds heal better with some controlled moisture but still able to breathe - are you saying that nipple skin is totally different?

Yes, in my article Re-thinking lactation-related nipple pain and damage I discuss the mechanobiological model of nipple pain and damage, and using that model, show why traditional moist wound healing methods are inappropriate for the quite special environment of the lactating woman’s nipple. Table 1 of that article shows the unique protective factors and risks of the lactating nipple. Traditional moist wound healing methods cause overhydration of the epidermis and actually worsen nipple epithelium’s risk of inflammation and damage. We then need to support pragmatic approach by educating women about the risks of overhydration, even as they manage bras, breast pads, and protect against worsened damage when wearing them. Table 2 page 13 of this same article looks at the evidence which shows that the use of lanolin and hydrogel do not improve healing, though they have a role in preventing a broken epithelium from sticking to the breast pad.

20. A “posterior tongue tie” is actually located at the body of the tongue. Why is there no mechanical way this would cause bf problems? It is the body of the tongue that is doing most of the work for feeding. The anterior tongue only has to cover the gums

Actually, there is no anatomic basis to the concept of a ‘posterior tongue tie’. There is nothing anatomically or histologically in the body of the tongue or oral connective tissue or fascia which corresponds with this diagnosis.10 We don’t use the diagnosis of posterior tongue-tie (or upper lip-tie or buccal ties) in the NDC breastfeeding domain. The diagnosis of ‘posterior tongue tie’ significantly increases the risk of costly interventions including unnecessary frenotomy and unnecessary bodywork. There are other things that explain the list of signs and symptoms that are attributed to PTT, and I’d invite clinicians to experiment with these different ways of making sense of what is going on for that breastfeeding woman and her baby. A list of my multiple scientific publications on ankyloglossia can be found on this page.

21. Thank you for this lecture I would like to ask about a mupiricine which was mentioned in 26 protocol in women with damaged nipple

Topical antibiotics are overused in wound healing generally, and we do need to remember that exudate is part of the normal wound-healing process and is protective. If there is worsening inflammation and swelling of the peri-wound tissue, antibiotics are required. Sometimes I might prescript mupirocin if there is a heavy purulent malodourous discharge, but by the time there is peri-wound cellulitis of any significance, going straight to oral antibiotics is likely to be necessary.

22. Please could you discuss your evidence or the rationale for the claim that nipple blebs require unroofing?

Actually applying the mechanobiological model, I have proposed 3 kinds of ‘white spots’ in my article on nipple pain and damage page 8, none of which are called a nipple bleb. ‘Nipple bleb’ is a term that is not used in NDC categories applicable to nipple pain and damage. I have proposed that there is:

a. hyperkeratosis, the most common presentation that is popularly called a white spot, due to repetitive micro-trauma from ‘breast tissue drag’ – repetitive mechanical forces;

b. milk blister, which is the occasional growth of epithelium over a duct orifice resulting in back-up of milk in the lactiferous ducts behind that orifice. This is the rare kind that may benefit from unroofing.

c. milium, which requires no treatment.

Please go into my article to see further discussion of this classificatory system of white spots. Proposed treatments and relevant studies are further detailed in Table 2 page 12.

23. If not using cross cradle initially to help get a latch, what position do you recommend?

We use the gestalt method of fit and hold, which is detailed in three publications, and for parents at drpam.au. Please see Question 7.

24. I am feeling unsettled - as though I’ve learned all wrong - so many things I’ve been taught are discouraged here: lymphatic massage, discouraging unroofing of milk nipple blebs, cross cradle hold with areolar compression to help babe latch on.

I acknowledge that it is unsettling when someone proposes approaches that are very different to commonly used models. It seems to me that when we are referring to models, and there are limited evaluation studies, a clinician can only decide herself how sound the underlying scientific rationales appear to be, and then experiment in her clinical practice, discussing various options with the patient and family and the underlying scientific rationale in patient-centred decision-making going forward.

25. How did you conclude that study discussed on slide 28 (therapeutic breast massage) is an RCT, or that it had low follow up? I just re-checked the publication, which is a quasi experimental trial, with a nested case-control among the women with engorgement. When analyzed as such, the f/u is high: 1) 90% at 2 days & a 95% at 12 wks for the entire TBM group, & 2) 100% at 2 days & 87% at 12 wks in the engorgement sub-group. When analyzed appropriate to the methodology used, the gentle massage was found to be both beneficial & very well tolerated

Thank you, I agree that I made a mistake in the way I represented the follow-up. Please see previous questions and also my article here which offers an Erratum, and I do apologise. However, we need to be careful about distinguishing what the data tells us, from how authors interpret their own data. Although there was excellent follow-up in Witt et al, which I reported on erroneously, I discuss why we cannot draw the conclusion that gentle massage from the nipple to the areola is beneficial for breast inflammation. The other two components of Therapeutic Breast Massage, hand expression and infant suckling to remove milk, are predicted by the mechanobiological model of breast inflammation to explain the results in the Witt et al study, which does not control for the powerful neurobiological effects of expectation in both health professionals and parents.

26. Can you go into more detail on the risk of cross cradle?

An Australian study by Thompson et al demonstrated that cross-cradle hold significantly increases the risk of nipple pain and damage.(11)

27. What holds do you recommend to best reduce nipple and breast tissue drag?

In the NDC breastfeeding domain, we use the gestalt method of fit and hold, which integrates

1. The gestalt biomechanical of infant suck and its implications

2. Physiological initiation of breastfeeding (activation of mammalian breastfeeding reflexes)

3. Neurobiological model of unsettled baby behaviour

4. Applied functional contextualism (psychological strategies)

Please see Question 7 and other questions for more discussion.

28. Can you describe how you talk to moms about drag and help them correct positioning based on this.

This is a big topic, and the method is described for researchers and health professionals earlier in this article. We have lots of videos and materials to help parents with this approach, currently found in The Possums Sleep Program but to be released before the end of 2024 in Breastfeeding stripped bare drpam.au.

29. To Pam Douglas: I really appreciate your neuroprotective and infant focused approach to clinical support to breastfeeding dysds, using new language to reframe classic and important paradigms. And I appreciate your bravery in challenging received wisdom and the decades of deep and important research by others who acknowledge they stand on the shoulders of giants.

You will see, on perusing the citations of my trilogy of articles concerning breast inflammation and nipple pain in lactation, that I analyse and cite many hundreds of relevant studies. This is how I build ‘on the work of giants’! Beyond that, NDC is developed out of thousands of research articles across multiple and interdisciplinary domains concerning breastfeeding, infant cry-fuss problems and sleep over two decades, with the help of multiple research teams. You can read these research publications here, in pdf form.

I think it’s not right to state that Neuroprotective Developmental Care uses new language to reframe existing, classic and important paradigms, since so much of what NDC offers is quite different to existing models, which are often highly medicalised. There is a great deal of unnecessary medicalization and pathologisation of both mother and infant in dominant clinical breastfeeding support approaches at present. The NDC programs aim to avoid this, and hand power back to the family. Just worth noting too that our neuroprotective interventions apply to both parent and infant. Choice of words is very important in the way we interact with patients, and NDC does propose a whole range of terms and verbal scripts for clinicians. I use a lot of these terms in my book for parents on infantcare, which translates the NDC programs into stories for parents, The discontented little baby book. These terms are also taught in our Masterclasses and NDC Accreditation pathway for health professionals.

I'm answering these questions here on a Saturday afternoon about just one aspect of clinical breastfeeding support, breast inflammation, and you’ll see immediately how different much of what I’m proposing in this one small area of clinical breastfeeding support is to current accepted treatments. This is because of the evolutionary biology and complexity science frames.

30A. To take such a stance, please take care that you don't misunderstand the literature, and the work that you challenge. Witt &Bolman have an 90% return rate not 34%.

Yes, please see my previous Erratums and also this article on the Witt et al study and massage in breastfeeding.

30B. A phlegmon is not only a radiologic diagnosis but a surgical diagnosis, and a path specimen will convince you.

Please see Question 4B for a response and further discussion in my article critiquing ABM CP#36. A phlegmon has no meaningful definition by signs and symptoms on the spectrum of breast inflammation presentations. Diagnosis by ultrasound or path specimen lacks a consistent definition. Of course, we need to ask why we are taking biopsy for a pathology specimen of an inflamed lactating breast - or is the questioner conflating other surgical presentations of phlegmon elsewhere in the body with breast inflammation?

I argue that surgical presentations labelled phlegmon in other parts of the body cannot be extrapolated to the lactating breast. Both histological and ultrasound evidence of hyperaemia and interstitial fluid will be found on a spectrum of tissue inflammation, also on a spectrum of microscopic to macroscopic fluid collection which falls short of abscess. This diagnosis of phlegmon is unnecessary for clinicians who wish to effective manage breast inflammation in lactating women, and I propose will not help improve outcomes for women, but drive up health system and patient costs due to the risk of unnecessary use of ultrasound imaging. If there was reason to think that the diagnosis phlegmon actually leads to improved outcomes, then I would hold a different view.

30C. The article about nipple blebs by a breast surgeon was not an abstract but a full article in the journal of mammary gland biology and neoplasia.

I analyse Mitchell & Johnson’s 2020 study, published in the Journal of Mammary Gland Biology and Neoplasia, in detail on page 9 of ‘Rethinking lactation-related nipple pain and damage’. In this study of a US breastfeeding medicine practice, 34 women were treated for blebs, 17% of all referrals for the duration of the study, at the same time as the clinicians addressed milk supply that was in excess of the infant’s needs, as deemed relevant. One patient who presented with an uncomplicated bleb at five months postpartum was not compliant with prescribed lecithin or topical triamcinolone therapy, and repeatedly unroofed her bleb at home. Five months later excision and pathology of this lady’s nipple lesion showed squamous hyperplasia, consistent with the NDC category of white spots called hyperkeratosis.

On page 9 of ‘Rethinking lactation-related nipple pain and damage’ I also discuss the 2012 abstract (only) published by Dr O’Hara, which analysed punch biopsies of painful white spots from five breastfeeding women, finding no bacteria or fungi, but identifying leukocytes and fibrin, consistent with inflammation of hyperkeratosis.(12)

31. I do think you owe the audience a dislaimer that these are you own very interesting and creative interpretation of the literature, as well as how often the NDC approach are often restatements of good established management strategies.

Clinical breastfeeding support is a research frontier, with relatively little in the way of methodologically robust evaluative studies to guide us. You will see that the NDC work is developed using implementation science, step by step, over the past two decades. If the questioner was to gain deeper knowledge of NDC, he/she/they would appreciate the significant differences that exist with accepted experience or opinion-based management practices which often dominate currently. The development of NDC has comprised, according to implementation science:

1.Development of models drawing from existing interdisciplinary evidence

When I use the terms ‘model’ and ‘theoretical frames’, which I use repeatedly both in my presentations and in my research publications, including in titles and headings, I am alerting the audience or reader to the fact that I am interpreting the literature in a particular way, to propose a model. In the case of NDC, as I explained at the beginning of the talk and in my publications, the lenses are evolutionary biology and complexity science. Developing models is the first stage of implementation science. I agree it is vital to acknowledge and name theoretical frames – which unfortunately does not occur, for instance, in ABM Clinical #36.

2. Clinical translation of the model – development of programs and interventions

Once we have a theoretical frame, which offers an explanation for something based upon existing research literature, this made available for debate within the field, and translated into a clinical intervention.

3. Iteratively integrate patient and heath professional feedback

We then gather up feedback from patients and pilot studies, making changes iteratively in response, and begin to layer up evaluative studies.

4. Evaluations, both qualitative and quantitative

I notice some people worry that I have labelled models using names e.g. gestalt biomechanical model of suck, NDC classification of breast inflammation, neurobiological model of cry-fuss behaviours etc. Some have even wrongly suggested this is for commercial purposes, perhaps not realizing that our independent charity is independent, receiving no external funding, and all revenue from the sale of parent or health professional education is returned to education and research. [Note: this is exactly the case in The NDC Institute, a social enterprise established now that the charity has folded.] Unfortunately it is true that a lot of breastfeeding support which is not evidence-based or consistent with implementation science really is promoted to benefit individuals financially.

In the world of clinical breastfeeding support, which has a relative paucity of methodologically strong studies to guide us, we are accustomed to making recommendations based on methodologically weak studies or just shared beliefs and opinions, stating these as fact. The underlying theoretical models are assumed, not stated or discussed – and unfortunately often apply reductive, or medicalized, lenses.

[New note 15 January 2024: Naming approaches which are derived from particular theoretical models is actually best scientific practice, but mostly not done in the world of clinical breastfeeding support. Clinical approaches which derive from (assumed, unexamined) theories are commonly presented as fact. Multiple examples of this are to be found in ABM Clinical Protocol #36, analysed here. It is a serious mistake to imagine that clinical approach derived from an explicit model, transparently named so that it can be critiqued, replicated and evaluated, is a branding ploy. I'm afraid that this position betrays a lack of understanding of how research and implementation science should function, in order to serve the best interests of breastfeeding women and their babies.]

32A. IABLE recommends against nipple shield use in recent Nicu Picu conference.

Nipple shields are commonly used as a substitute for the clinical skills required to both identify and then eliminate breast tissue drag during breastfeeding. That is, nipple shields are overused. Perhaps this is what the presenter at the Nicu Picu conference was referring to. However, nipple shields need to be part of our toolkit as we support breastfeeding women who present to us with problems (even if those problems are preventable and we hope one day will be avoided.)

In Table 2 p 12-13 of ‘Rethinking lactation-related nipple pain and damage’, I detail evidence-based management of lactation-related nipple pain and wounds. At the very beginning in the third column ‘secondary or adjunct interventions’, I state that both a 2015 systematic review and a 2021 review conclude that nipple shield use substantially benefits breastfeeding when problems emerge, both in measurable outcomes and in reports by mothers. Please see this table for further discussion of nipple shield use. I note that ABM Clinical Protocol #36 refers only to an outdated 2010 study.

If I work with a woman who is using nipple shields, or I recommend them, I am at the same time teaching a woman the steps of the gestalt approach to fit and hold and helping her undo any conditioned dialing up at the breast that the baby may have learnt.

32B. How do we reconcile differences in our education acknowledging more research is needed? We of course want to give out correct no conflicting information. Thank you

I do think this is a critical question. In the absence of methodologically strong studies which evaluate different approaches, including RCTs, then we are relying upon models which are translated into clinical approaches. Obviously in developing up the NDC programs I aim to offer evidence-based programs for health professionals to use with parents, which have very strong theoretical foundations based in thousands of research studies, and now about nine positive evaluative studies. NDC aims to minimise the conflicting advice that parents receive. Rigorous and respectful debate of underlying theoretical frames is essential, as we turn them into clinical programs, which is my intention here.

33. Can you comment on your gestalt fit and hold method?

Please see Question 7 and other questions previously.

34. Was there any consideration or discussion of using hand expression rather than pumping for your study?

My research studies on breast inflammation are reviews and theoretical re-framing, from which I’ve developed new clinical protocols. In the management of breast inflammation, you will see I preference hand expression for milk removal that is not performed by the baby. I do not have evaluative studies for our work on breast inflammation, though I look forward to that. But I analyse all existing evaluative studies that I could find in literature searches to propose a way forward. To that end, I recommend hand expression and only very judicious pumping but aim to inform the woman why we might want to avoid pumping. Informing parents of the underlying models you rely upon, and allowing a breastfeeding women to enter into the decision-making, explaining which models you rely upon and why, hands power back to her.

Dr Pamela Douglas is Director of The NDC Institute (ndcinstitute.com.au). Associate Professor (Adjunct), School of Nursing and Midwifery, Griffith University, Australia; and Senior Lecturer, General Practice Clinical Unit, The University of Queensland, Australia. She is the first author of about 30 international research publications which detail the evidence-base to the programs known as Neuroprotective Developmental Care, or the Possums programs, which rest upon evidence-based clinical breastfeeding support as its foundational domain.

References

1. Witt AM, Bolman M, Kredit S, Vanic A. Therapeutic breast massage in lactation for the management of engorgement, plugged ducts, and mastitis. Journal of Human Lactation. 2016;32(1):123-131.
2. Anderson L, Kynoch K, Kildea S, N L. Effectiveness of breast massage for the treatment of women with breastfeeding problems: a systematic review. JBI Database Systematic Reviews Implement Rep. 2019;17(8):1668-1694.
3. Geddes DT, Gridneva Z, Perrella SL, Mitoulas LR, Kent JC, Stinson LF, et al. 25 years of research in human lactation: from discovery to translation. Nutrients. 2021;13:1307.
4. Armstrong N. Overdiagnosis and overtreatment: a sociological perspective on tackling a contemporary healthcare issue. Sociology of Health and Illness. 2020;43(1):58-64.
5. Douglas PS. Re-thinking lactation-related nipple pain and damage. Women's Health. 2022;18:DOI: 10.1177/17455057221087865.
6. Douglas PS, Geddes DB. Practice-based interpretation of ultrasound studies leads the way to less pharmaceutical and surgical intervention for breastfeeding babies and more effective clinical support. Midwifery. 2018;58:145–155.
7. Douglas PS, Keogh R. Gestalt breastfeeding: helping mothers and infants optimise positional stability and intra-oral breast tissue volume for effective, pain-free milk transfer. Journal of Human Lactation. 2017;33(3):509–518.
8. Douglas PS, Perrella SL, Geddes DT. A brief gestalt intervention changes ultrasound measures of tongue movement during breastfeeding: case series. BMC Pregnancy and Childbirth. 2022;22(94):https://doi.org/10.1186/s12884-12021-04363-12887.
9. Samuel TM, De Castro CA, Dubascoux S, Affolder M. Subclinical mastitis in a European muticenter cohort: prevalence, impact on human milk (HM) composition, and association with infant HM intake and growth. Nutrients. 2020;105:doi:10.3390/nu12010105.
10. Mills N, Keough N, Geddes DT, Pransky S. Defining the anatomy of the neonatal lingual frenulum. Clinical Anatomy. 2019;32:824-835.
11. Thompson RE, Kruske S, Barclay L, Linden K, Gao Y, Kildea SV. Potential predictors of nipple trauma from an in-home breastfeeding programme: a cross-sectional study. Women and Birth. 2016;29:336-344.
12. O'Hara M. Bleb histology reveals inflammatory infiltrate that regresses with topic steroids: a case series. Breastfeeding Medicine. 2012;7 (Suppl 1):S2.