A Macrolane injection is an aesthetic medicine procedure that increases breast volume without resorting to breast implants.
\nThe procedure is no longer performed by Dr. Kron following the decision of the ANSM (French National Agency for the Safety of Medicines and Health Products). For people seeking a similar result in terms of volume, breast lipofilling is an effective alternative to Macrolane breast augmentation.
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Paris,
\nSeptember 6, 2011
\nSubject: Decision of the AFSSAPS (French Health Products Safety Agency) excluding the indication of aesthetic breast augmentation for injectable filler products (Macrolane)
\nDear Madam,
\nThe AFSSAPS has decided to exclude the indication of aesthetic breast augmentation using injectable products such as hyaluronic acid (Macrolane). This decision was motivated by the results of a recent study which highlighted risks of disruption to imaging scans and difficulties in breast palpation during clinical examinations. According to the study, these risks are increased with repeated injections.
\nThe consequences of these risks include a possible disruption to breast cancer screening.
\nThis decision is a very strict application of the precautionary principle. As the AFSSAPS acknowledges, there is no case in clinical studies, the literature, or Macrolane's post-approval surveillance database that reveals any new adverse effect or risk since Macrolane was brought to market in 2008. Thanks to its effectiveness and good tolerance, Macrolane has brought great satisfaction to more than 15,000 patients worldwide.
\nRegarding the specific case of patients who have been treated by me:
\nYou should continue your clinical monitoring at the frequency I have requested, based on the time since your injection with me. Please note that should you need a mammography and/or ultrasound examination of your breasts, I recommend having it performed with Dr. LEBAR, a radiologist who co-wrote this letter with me and who runs a leading radiology practice in breast cancer screening. We have worked together from day one on the clinical examination, screening and analysis of mammography and ultrasound images for patients treated with Macrolane, and Dr. LEBAR therefore has extensive experience reading these images. This poses no problem for diagnostic breast cancer screening combining mammography and breast ultrasound.
\nPlease also note that Macrolane is fully resorbed between 18 and 24 months, and once this full resorption is complete, you will be able to undergo mammography and ultrasound examinations in the same way as other women.
\nIn conclusion, should you have any concerns, I recommend a clinical examination with me and a mammography and/or ultrasound examination with Dr. LEBAR. Please note, however, that the AFSSAPS confirms that women who have undergone breast augmentation with injections of a product such as Macrolane are not subject to any particular medical follow-up other than what I had already planned for you. They should continue to attend the follow-up consultations scheduled in this way. Should an ultrasound or MRI be needed, it is important to inform the radiologist of the date of your injection.
\nYou can also find additional information on the AFSSAPS website, and I will list on my website the links that give you direct access to information on this subject.
\nN.B.: Today, for breast augmentation treatment, you therefore only have access to augmentation using prosthetic implants (breast implants).
\nIndeed, injection by autologous fat cell grafting is also not recommended because, to date, while it does not interfere with screening, fat cells release growth factors, which could induce accelerated development of breast cancer.
\nDr. LEBAR and Dr. KRON remain available for any further information and kindly ask you to accept their best regards.
\nDr. Cédric KRON\nPlastic Surgeon\nPhone: +33 1 45 62 85 00
\nDr. Philippe LEBAR\nRadiologist\n199, rue de Grenelle 75007 Paris\nPhone: +33 1 47 05 51 87
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