Q-Med AB Discontinues the Breast Indication for Macrolane
4/17/2012 10:33:20 AM
UPPSALA, Sweden--(BUSINESS WIRE)--Macrolane is a safe and well-tolerated injectable product used to augment body contour and correct soft tissue defects. Introduced in 2008, it has improved the quality of life of thousands of patients in indications ranging from HIV-related lipoatrophy to breast augmentation. A safety reporting system has been in place since launch and no safety concerns have been identified. However, 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, a Galderma division has therefore decided to discontinue the indication until consensus for best practices in breast radiology examination following Macrolane treatment has been reached.
Macrolane is a non-permanent gel consisting of stabilised hyaluronic acid, which is naturally broken down by the body. 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.
All breast augmentation procedures, including those involving Macrolane, can interfere in the reading of mammograms. This is well-recognized and readily addressed by using additional standard assessment techniques. The Macrolane product information intended for physicians and women undergoing treatment provides very clear information on this. Hence, there are recommendations on the importance of baseline examination, the use of digital mammography and possible need for additional ultrasound examination to obtain adequate information on the breast tissue for screening purposes. These additional assessments are currently proposed by leading European experts in the field of radiology.
To validate this recommendation, Q-Med conducted a 24-month study in Sweden and France to assess the usefulness of the combination of digital mammography and ultrasonography performed at the same time. The preliminary results of this recently completed study show that an adequate examination can be performed using these techniques. Q-Med intends to make this data available to the wider radiologist community. In parallel Q-Med will also continue to investigate the need to update the current recommendations on breast radiology examination as new techniques become available.
Q-Med will be informing its customers of the changed instructions for Macrolane use over the coming days and will make consumer information available on the websites and in doctors’ surgeries.
Macrolane is manufactured by Q-Med, a Galderma division, in Sweden. The product is a crystal-clear gel based on stabilized hyaluronic acid, a naturally-occurring component of human tissue, and is naturally biodegraded by the body’s own enzymes over time. Hyaluronic acid is a safe material used in millions of treatments for various medical and aesthetic conditions worldwide. As a natural component of the skin, hyaluronic acid binds water and helps maintain volume. Macrolane has been developed to provide a less invasive reconstructive and aesthetic treatment.
About Q-Med, a Galderma division
Q-Med, a Galderma division, develops, manufactures and markets solutions for aesthetic and corrective treatments. The division offers a complete worldwide portfolio in the aesthetic field including the brands Restylane, Emervel, Azzalure, Dysport*. Deflux, Solesta and Durolane are other products improving patients’ health in the corrective field. Since 2011, Q-Med is wholly owned by Galderma, a global pharmaceutical company specialized in dermatology with nearly 4,000 employees and present in more than 70 countries. The site in Uppsala, Sweden, is Galderma’s Global Center of Excellence for aesthetic & corrective products.
For more information about Q-Med: www.q-med.com
For more information about Galderma, please visit www.galderma.com
* Dysport is a trademark of Ipsen
Annika Öhlin, +33 1 58 86 45 37