This week Q-Med (a division of Galderma) took the decision to discontinue the indication for use of its hyaluronic acid gel product Macrolane™ in breast augmentation procedures following concerns over the product’s interference with mammogram checks for breast cancer.
Macrolane, launched in the UK in 2008, is a non-animal stabilised hyaluronic acid (NASHA) gel produced as a highly viscous, non-permanent product for injection into the body for volume restoration and shaping of areas such as calves, buttocks and breasts and to correct soft tissue defects such as evening out the discrepancies sometimes caused by liposuction procedures. It has also been used in cases of HIV induced lipoatrophy. It is for the breast (augmentation) indication that it has been discontinued by the manufacturer. No question or concern has been placed over the safety of the product, following a safety reporting system which has been in place since launch (although some disagree over this) and it continues to be indicated for other body regions.
Consultant Plastic Surgeon and current BAAPS President, Fazel Fatah commented on the controversies over Macrolane safety by saying; “We have urged caution in the past against the use of fillers in the breast, especially when there is a lack of peer-reviewed results from controlled clinical trials. We have publicly aired concerns before regarding lump formation and capsular contracture in the breast from the use of Macrolane.”
However, opinions differ and Mr. Christopher Inglefield, a Cosmetic Surgeon from London Bridge Plastic Surgery told us; “Having used Macrolane for breast enhancement successfully since 2007 with very good patient satisfaction and low rate of adverse events in over 300 patients, I was disappointed to be told about Q-Med’s decision to withdraw the breast indication for Macrolane. However, on reviewing the issues existing throughout Europe, I support Q-Med in taking this decision, which is not about safety of the product.”
Q-Med themselves said in their press release on the matter; “...all breast augmentation procedures, including those involving Macrolane, can interfere with the reading of mammograms. At present, there is a lack of consensus amongst radiologists regarding radiology examination of breasts treated with Macrolane. After reviewing the current situation and in consultation with the regulatory authorities, Q-Med has therefore decided to discontinue the indication until consensus for best practices in breast radiology examination following Macrolane treatment has been reached.”
The British Association of Aesthetic Plastic Surgeons (BAAPS) have welcomed this withdrawal of what they refer to as a controversially marketed ‘lunchtime boob jab’ which they have urged caution on in the past. They noted that a survey amongst their members had previously shown than 1 in 4 plastic surgeons were seeing patient complications following the use of Macrolane, and that additionally a study published in December 2010 in the Journal of Plastic, Reconstructive & Aesthetic Surgery (link opens PDF) by former BAAPS President Barry Jones and current BAAPS President-Elect Rajiv Grover, warned it could interfere with breast screening and also noted that patients were needing corrective surgery after the treatment.
According to Fazel Fatah; “The concept of simply injecting a temporary filler to augment the breast may seem appealing – especially to those marketing ‘lunchtime boob jobs’ – but any treatment can only be considered safe once it is known what long term effect it has on cancer screening as this can affect such a high proportion of women. Without good long term studies over 5 to 10 years it is wise that Macrolane has finally been withdrawn for breast use.”
It is well recognised in the medical community that whether a breast augmentation is performed with saline or silicone implants, fat grafting or with Macrolane, they can all interfere in the reading of a mammogram which looks at the breast tissue for abnormalities which could be cancerous or pre-cancerous. Because of this fact it is addressed by using additional standard assessment techniques when performing breast checks on women with augmented breasts.
Chris Inglefield explains further; “Concerns have been raised about the screening of patients with Macrolane and the assessment of patients with symptomatic breasts. It is relevant that all procedures on the breast affect reading of mammograms to some extent including fat grafting, breast implants and Macrolane. Specialists in breast radiology agree that assessment of the breast with Macrolane (which is 98% water) is no more problematic than for an implant. It may in fact be less difficult compared to breast implants or fat grafting in the breast. There is clinical evidence published on the radiological evaluation of Macrolane in the breast. However, there is insufficient robust evidence available to allay the concerns of the breast radiologists and hence Q-Med made the decision. I am confident that Q-Med will rise to the challenge and gather the data necessary to confirm the safety of radiological assessment in women with Macrolane.”
Q-Med themselves recommend the importance of baseline examination, the use of digital mammography and the possible need for additional ultrasound examination to obtain adequate information on the breast tissue for screening purposes. They validated these recommendations based on a recently completed 2 year study in Sweden and France which assessed the usefulness of the combination of digital mammography and ultrasonography performed at the same time, the preliminary results of which showed an adequate examination can be performed using these techniques. Thus they intend to disseminate this data to the wider radiologist community as well as continue to investigate the need to update current recommendations on breast screening. Whilst this goes on they have chosen to discontinue the breast augmentation indication for Macrolane as a cautious measure, or as some would say, in a move aligned with “it’s better to be safe than sorry”.
So what about those women who have had Macrolane for a breast augmentation procedure? Q-Med would like to reassure them and included this in their statement; “Since no safety concerns have been identified, with the product itself, women who have undergone breast augmentation with Macrolane do not need to take any additional actions other than the routine follow-up consultations or as directed by their doctors. As with any other breast prostheses, it is important to inform the healthcare professional of previous Macrolane treatment before any breast assessment is carried out.”
Macrolane has courted controversy since its launch 4 years ago, however aside from disparities over its safety (particularly in the long term) and the reporting of past concerns, it’s nice to see a well known manufacturer taking a preventative step over the use of a product, rather than simply putting profit first.