Macrolane, a product of Q-Med of Sweden, has been withdrawn till further notice from the market as an injectable filler for breast enhancement, as per a press release by the company and other press reports.
The decision was taken after apprehensions regarding interference of the injected material with breast cancer screening were expressed by radiologists and other experts. The Medicines and Healthcare products Regulator Agency (MHRA) of UK stated that Macrolane could affect mammogram readings and make diagnosis more difficult.
Many plastic surgeons in UK welcomed the decision and a survey taken by British Association of Aesthetic Plastic Surgeons (BAAPS) found that many of the members observed complications from the filler among the patients.
BAAPs linked the safety of a treatment to its effect on cancer screening on long term basis, which is still unknown in the case of treatment with Macrolane.
BAAPS stated that they earlier urged caution against the filler use in the breasts in absence of “peer reviewed results from controlled clinical trials” and also referred to their earlier “expressed concerns about lump formation and capsular contracture- the hardening of breast tissue around the implant- arising from the use of Macrolane”.
Macrolane was launched in 2008 as a filler to be injected for breast enhancement and as per BAAPS, about 1000 women in UK opted for this procedure. The procedure involved injecting Macrolane subcutaneously under local anaesthesia with results seen instantly without any down time.
Though stress in the treated part was to be restricted for a few weeks and a few common injection related reactions could occur, this non-invasive procedure enjoyed several distinct advantages over the surgical implants. That was why the procedure became quite popular for breast enhancement and earned the epithet “lunchtime boob job” due to the quick time it took to give results to the patient.
As per Q-Med, Macrolane consists of hyaluronic acid and water and gets metabolised in the human body within 12 to 24 months of the injection and is indicated for volume restoration, body contouring involving chest wall, buttocks, calves.
It can also be used to fill defects caused by liposuction and surgical scars. The company reported that no safety concern about the filler has been identified and that it would continue to be available for other uses such as for body contouring, treating soft tissue defects.
As per Q-Med the decision to withdraw the Macrolane as breast filler, has been taken “due to lack of consensus among radiologists regarding best practices in the examination of breasts treated with Macrolane.”
They stated that all breast implant procedures including the one with Macrolane interfere with Mammograms. According to them, this is a well recognized fact but this can be addressed by using techniques such as digital mammography, additional ultrasound examination to collect adequate breast tissue information for a clearer assessment.
They stated that they carried out a 24 month study in Sweden and France to see the result of concurrent use of digital mammography and ultrasound examination and the preliminary results show that adequate examination can be carried out by using these techniques.
They plan to make available the information and data from the study to the community of the radiologists and also would investigate the need to update the present radiological assessment practices using latest techniques. Similar concerns had been made regarding using fat to fill breasts (natural breast augmentation), but apparently the calcifications from this procedure are different than suspicious calcifications.
They stated that they would soon inform the customers of the changed instructions of Macrolane use and would present consumer information in the web site and in doctors’ clinics. They also stated that the women, who had undergone the procedure with Macrolane, need not take up any additional tests or procedure apart from the routine follow up consultations and any procedure specifically prescribed by their doctor.
In conclusion, Macrolane hyaluronic acid type filler is not available for breast enhancement. The best method for breast enhancement is still through the use of implants, either saline or silicone.
[Source: This write up is sourced from the article titled “Breast surgeons back withdrawal of ‘lunch time boob job’ jab” in BBC Health dated April 21, 2012]