of Breast Cancer in Patients with Siliconomas

Fig. 12.1

(a–c) Mammographic images in patients with the past injection of hyaluronic acid

Data regarding the role of HA in the inhibition or facilitation of breast cancer cell growth remain inconclusive, though there is evidence that could link the presence of HA in the vicinity of a tumor with its progression and resistance to chemotherapy [16, 17]. Despite these scientific publications, on May 3, 2012, under the heading “Safety of Medical Devices,” the Spanish Agency for Medicines and Health Products (AEMPS) restricted the use of Macrolane® injectable filler implants for breast enlargement for aesthetic purposes, because HA was believed to interfere with early detection techniques for breast cancer. Subsequently, the French Agency for the Health Safety of Health Products (AFSSAPS) informed the Spanish AEMPS, as well as other European health authorities, about its decision to restrict the use of injectable filler implants for aesthetic breast enlargement, as a precautionary measure. The AFSSAPS decision was motivated by the preliminary results of a study that highlighted the inherent risks of injecting such substances into the breast, due to their interference with physical examinations and the reading of mammograms for early breast cancer detection. In France, the only product affected by the AFSSAPS decision is Macrolane® (HA) injectable gel, manufactured by the Swedish company Q-Med AB.

Reports that the AEMPS have received from medical societies conclude that such fillers injected into breast tissue can cause accumulations to form, due to fragmentation and encapsulation of the product, both of which interfere with breast physical examinations and the interpretation of mammograms. Accordingly, Swedish authorities have announced that the company, Q-Med AB, is ceasing all marketing of Macrolane® as a product for breast augmentation. Taking the available data into account and the reports of the medical societies received by the AEMPS, the following actions should be taken:

Ceasing the use of Macrolane® and any other injectable filler implant to increase breast volume for aesthetic purposes.
Taking into account such products’ potential interference with breast physical examinations and mammography interpretation, performing complementary diagnostic tests to aid with the early detection of breast cancer in patients treated with Macrolane® or any other injectable breast implant filler.

Among patients treated with Macrolane® or with any other injectable filler for breast augmentation:

Ensuring that professionals who perform routine breast exams are informed when this type of injectable has been used, before diagnostic images are obtained.
Ensuring that patients continue to have scheduled follow-up visits after treatment.

Given the well-known medical problems and diagnostic difficulties associated with the injection of liquid silicone, the emergence of new injectable products for breast augmentation warrants clinicians’ continued vigilance among all patients who have received them.

To understand women’s motivations to seek out such procedures, the following reflection might be useful. The breast is an anatomical attribute that is not only inherent in a woman’s body structure; it also is intricately entwined with their concepts of femininity, sexuality, and motherhood. Many women seek the ideal figure, which consists of a slim body but shapely breasts. However, since breasts are mostly composed of adipose tissue, few women can achieve both these desirable attributes naturally. This is why breast augmentation is the most commonly performed cosmetic procedure. Moreover, its popularity is growing. Since 2000, this increase has been 55% per year [18].

Dissatisfaction with the size and shape of their breasts makes woman seek various means for breast enhancement. In one study of 18-year-old women, one third were dissatisfied with the appearance of their breasts [19]. Despite the prevalence of this discomfort, only a small proportion of women seek to alter their breasts procedurally. The availability of a minimally invasive, relatively low-cost procedure causes certain physicians and non-physicians, who place personal gain over ethical considerations, to offer it secretly while downplaying the risks of future complications. Women enticed by the procedure’s simplicity, low cost, and lack of surgical intervention will continue to fall victim to such charlatans.

With this in mind, it should come as no surprise if other similar substances emerge in the future, even if products like silicone and other currently disfavored products fall from use.