Independently Clinically Trialled

Extensive studies recommend breast massage (movement and compression) in lactation together with temperature for the resolution of many common breastfeeding issues.

These three components have the ability to improve blood circulation and facilitate lymph drainage. Breast massage in lactation also has the ability to proactively improve the quality of breastmilk by increasing total solids, lipids, casein concentration and gross energy.

Deakin University and the Western Health Partnership carried out an independent clinical trial on Lactamo. Producing highly successful results, the trial was nominated for the Mary Paton Award.  

100% of women in the trial “reported that they would recommend Lactamo to other mothers to assist their lactation”, and 100% of women who used Lactamo "felt that it was beneficial for their lactation". 

Recently published in the International Breastfeeding Journal, the trial was a pre-market evaluation of Lactamo, looking at safety and user satisfaction. Conducted in an Australian tertiary maternity hospital, all women were 3-months postpartum and currently breastfeeding (n=30). Structured telephone interviews were carried out at 1 and 4 weeks supply of Lactamo, with questions covering demographics, perceived safety and benefits and usability. 

The reasons women chose to use Lactamo in the trial varied, but for most women who used it (n=25/27; 93%), a lactation condition or situation prompted its use. The trial reported: 

• most women experienced more than one lactation concern (n=24/27; 89%)
• 63% of women had at some point expressed their breastmilk 
• ~50% of women sought advice or reassurance from a health professional at some point in their lactation journey

Findings from the trial included:

• The most common lactation concern that prompted the use of Lactamo was the sense of full and painful breasts or engorgement. All the women experiencing these concerns found using the device very helpful. One mother said, “when my breasts are engorged, I think it definitely helps get the milk out”.
• Lactamo was "useful when experiencing blocked ducts and pain". One mother explained, “I think it helped the milk come out easier and helped the breast pain. I used the ball to massage out the lumps and it worked”. For some it was used as a preventative tool. “I have used it more in the last couple of weeks because I had a bit of pain from time to time on both sides, so I wasn’t sure if I had a blockage, so for me I use it as a preventative and a method of relieving pressure or pain”.
• Some women chose to use it prior to feeding or expressing to promote let down and breast emptying. As explained, “I tried it while feeding … and while pumping. It was better using the ball [Lactamo] and it was warmer and released the milk more easily [than hand massage]”. One woman found using Lactamo shortened her expression time. She explained, “I massage with it – [I get the] same volume but in less time pumping”.
• “I like that the spikes vary on each side - a softer side and a spikier side”.
• Lactamo was reported to "improve milk production while expressing".
• Lactamo was used "daily to relieve symptoms of blocked ducts [and] mastitis".
• "I use it when I missed my timing for pumping and my breasts get engorged and hard, and you can feel the ducts, so I use the ball to soften it up. I think it does a really good job - so it is in my pumping kit all of the time”.
• Lactamo was mostly commonly used in the early weeks of establishing lactation. “It definitely helps, particularly in first few weeks when I was still finding my mojo - at that point, I have never had issues with supply, but lots of lumps in my breasts, so it was really useful to help get those out. I was quite engorged and in pain”.
• “I use in the shower as I find it more convenient, and easy to add to the routine. Massage to improve supply, the warmth of water helps too - it just feels a lot better, my comfort with it [Lactamo] depends on pressure and fullness of the breast”.
• "It’s really fantastic!”
• "I had the mastitis, and it actually did help really well".
• “It’s easy to use, and it beats having to use your fingers for massage – you just roll it around – so it’s easier and more effective”.
• “It’s pretty easy to use, it’s not complicated”.
• "I think especially new mums who don’t know what they are doing, it will definitely benefit them”.
• Lactamo "was perceived to allow greater coverage of the breast than could be achieved by hand massage alone. A recent review has shown that breast massage is an effective method for managing common breastfeeding problems, however, no massage devices were included. The current observational study demonstrates that Lactamo may enhance the facilitation of breast massage as it can be easily guided around the breast. In addition, the ability to modify its temperature is an added benefit for addressing concerns, however, this function was not always used by the women. Increased milk production has been demonstrated with breast expression and areola compression with an electric expression device and by hand massage during breast expression. Furthermore, Oketani breast massage has been shown to increase total solids, lipids, and casein concentration and gross energy of breastmilk. While the women in the study indicated that their use of Lactamo may have increased their supply, the devices’ impact on breastmilk volume and composition warrants further investigation."
• Women who received Lactamo later on in their breastfeeding journeys "wished they had received it earlier".

The study author, Professor Linda Sweet, concluded Lactamo to be a valuable aid for breastfeeding women. 

The frequency and temperature with which women chose to use Lactamo varied widely. The women in the study indicated that their use of Lactamo may have increased their supply, and we are keen to further investigate this exciting area of Lactamo’s impact on breastmilk volume and composition. We are currently in early discussions for further clinical trials.  

Using Lactamo for the facilitation of massage was favoured by the women, indicating that application of Lactamo could be adjusted to meet their preferences for compression pressure.

The well documented benefits of temperature, movement and pressure (combined, breast massage) are clear, and the study showed Lactamo to be a valuable enabler in this process. 

Past studies and helping keep you up to date

Therapeutic breast massage in lactation for the management of engorgement, plugged ducts and mastitis (2015, Witt AM, et al.)

• This study aimed to describe clinical response to therapeutic breast massage in lactation (TBML) in the management of engorgement, plugged ducts, and mastitis.
• Reasons for the clinic representation included engorgement (36%), plugged ducts (67%), and mastitis (29%). Cases, compared to controls, were significantly more likely to have severe engorgement (47% vs 7%, p< 0.001). Initial mean breast pain level among those receiving TBML was 6.4 out of 10. Following TBML, there was significant improvement in both breast (6.4 vs 2.8, p< .001) and nipple pain (4.6 vs 2.8, p= 0.013). All women reported immediate improvement in their pain level. At 12 weeks, 65% found the massage treatment very helpful. The majority of the women with a new episode of mastitis or plugged ducts during the study follow-up found the techniques learned during the clinic visit very helpful for home management of these episodes.
• In office, TBML is helpful for the reduction of acute breast pain associated with milk stasis. Mothers find TBML helpful both immediately in-clinic and for home management of future episodes. 

Effectiveness of breast massage for the treatment of women with breastfeeding problems: a systematic review (2019, Anderson L, et al.)

• This 2019 study was a systematic review of breast massage as a treatment for women with breastfeeding problems. The objective was to identify if breast massage as an intervention led to less pain or increased milk supply, or assisted in a reduction or resolution of blocked ducts, breast engorgement and mastitis.
• The review concluded: different types of breast massage were reported as effective in reducing immediate pain and resolving symptoms of blocked ducts, engorgement and mastitis.
• The studies included in the review used unstructured or structured hand massage interventions, with or without heat packs, or massage combined with a massage medium such as crushed aloe and cactus. The review included no studies using a device to assist in breast massage.

Breast massage: can it keep mothers breastfeeding longer? (2019, Anderson L)

• Overall, it has been shown that breast massage in any form rapidly reduces pain for mothers and may allow continuation of breastfeeding until symptoms completely resolve. Referral to a health professional experienced in breast massage is recommended for lactating women as an additional treatment option for breastfeeding problems.
• The barriers associated with offering breast massage to all women with breastfeeding problems will continue to be an obstacle until more rigorous studies are undertaken.
• The lack of a universal, validated measurement tools for breastfeeding problems such as blocked ducts, engorgement and mastitis is also a challenge.

References: 

1. La Leche League International. Improve global breastfeeding practices. 2021. Available at: https://www.llli.org/2021-world-health-day-improve-global-breastfeeding-practices/. Accessed on: 13/02/2023. 
2. Seet L & Vasilevski V. Int Breastfeed J 2022; 17(23):1-9. 
3. Anderson L, et al. JBI Database System Rev Implement Rep 2019; 17(8):1668-1694. 
4. Witt AM, et al. J Hum Lact 2016; 32(1):123-131. 
5. Foda M, et al. J Pediatr Gastroenterol Nutr 2004; 38(5):484-487.