[Macrolane(®), a too premature indication in breast augmentation. Focusing on current knowledge of the product]. / Macrolane(®), une indication dans l'augmentation mammaire trop prématurée. Mise au point sur les connaissances actuelles du produit.

STUDY PURPOSE: For ten years the market for resorbable fillers has seen a large increase. A CE mark is sufficient for its placing on the market, they do not require AMM because they are not considered drugs. The Macrolane(®) is a hyaluronic acid NASHA gel-based technology, available on the French market since 2007 as filler used in all areas of the body except face and breasts. It is highly crosslinked, which slows its resorption, leaving in place long-term waste. At end of 2008, Macrolane(®) received a CE mark for breast augmentation. The aim of this paper is to review current scientific knowledge on the Macrolane™ and list the many uncertainties regarding its recent breast indication. MATERIALS AND METHODS: We reviewed the PubMed literature and study levels of evidence on Macrolane(®). All AFFSAPS communication and correspondence with the SOFCPRE on hyaluronic acids and particularly Macrolane™ were collected. RESULTS: At the moment there is no scientific study of high level of evidence which has studied the effects of Macrolane(®) on breast parenchyma in terms of carcinogenesis or the disruption of radiological monitoring of the breast. The subglandular method of injection remains complex and uncertain especially about the risk of wrong passage. CONCLUSIONS: The Macrolane(®) is proposed as an alternative less invasive than breast implants. Nevertheless the lack of scientific data on this product led to its non approval by the Food and Drug Administration in the United States. Currently there remains too much uncertainty on this filler for reasonable use plebiscite. It would therefore be preferable to return to the manufacturer the burden of proof of Macrolane(®) safety and security and limit its use in clinical trials yet.

The normal breast and its variations in mammography.

The mammographic appearance of the breast varies along the lifetime due to physiological modifications or use of hormonal therapies. Density of the glandular tissue is due to amount of cellular elements of the gland and to hydratation of the tissues. Normal variations are encountered as for example breast asymmetry. The currently breast composition should be described with the BI-RADS lexicon classification. Mammary asymmetry is frequent and has to be differentiated from pathologic changes. A good mammographic technique is mandatory for an adequate visualisation of the breast tissues.

[Presentation of the French translation of the Breast Imaging Reporting System and Data System (BI-RADS)]. / Présentation de la traduction française du BI-RADS (Breast Imaging Reporting System and Data System).

BI-RADS is a system of assistance to the drafting of the reports more and more used in the world and soon directly implemented on mammography and ultrasound units. The categories of evaluation of the BI-RADS allow a clear synthesis of the descriptive data resulting from the use of the lexicon and invite the radiologist to a reasoned, objective and less intuitive step. They give an action to be taken and responsibility to the radiologist and the referring physicians in the assumption of the patients. The 4th edition of the BI-RADS mammography appeared in 2003, and is now associated with the first editions of the BI-RADS ultrasound and MRI.

[Imaging of breast neoplasms]. / Imagerie du cancer du sein.

Imaging is crucial in early diagnosis of breast cancer. Mammography is still the most simple and reproducible method, except in dense breast. In these circumstances, ultrasonography may be helpful. Magnetic resonance imaging has some indications such as the diagnosis of local relapses and preoperative staging.

[Inserm ad hoc committee: Recommendations for the management of women with a genetic risk for developing cancer of the breast and/or the ovary]. / Expertise collective Inserm-FNCLCC: recommandations portant sur la prise en charge des femmes ayant un risque d'origine génétique de développer un cancer du sein et/ou de l'ovaire.

BACKGROUND: Almost 10% of breast and ovarian cancer are inherited, and the majority are linked to BRCA1 and BRCA2 germline mutations. Despite the uncertainty, consensus guidelines were defined to assist practitioners', and patients' decisions about the health care decisions to be made. METHODOLOGY: The ad hoc committee consisted of 14 experts designated by the French National Institute for Health and Medical Research. They all attended eleven workshops at which a systematic analytical review of more than 3,500 articles was carried out. Five additional experts critically analyzed the first version of the report. PROCESS: Two thresholds were defined on a probability scale giving the risk of developing breast or ovarian cancer, to serve as a means of deciding as whether an intervention is worthwhile. The first threshold is that above which an intervention can be envisaged or recommended; the second is that under which an intervention can be ruled out; between the two, the decision has to be made on a each by case basis. SCREENING AND PREVENTIVE STRATEGIES ANALYZED: About breast cancer: 1) hormonal interventions; 2) primary prevention (diet, family planning and chemoprevention); 3) screening (breast self-examination, clinician breast examination, tumor markers, imaging); 4) prophylactic mastectomy. About ovarian cancer: 1) hormonal stimulation; 2) screening (clinical screening, ultrasound and tumor markers); 3) prophylactic oophorectomy. MAIN CONCLUSIONS: With each strategy the following points were dealt with: the information to be delivered to the consult and, the procedure and the indications. The committee's opinion about BRCA mutation screening is that population-based or even large scale implementation are not justified. The committee feels that specific management is indispensable and advocates the use of defined and evaluated procedures, and involvement in clinical trials.

[Li-Fraumeni syndrome: update, new data and guidelines for clinical management]. / Le syndrome de Li-Fraumeni: mise au point, données nouvelles et recommandations pour la prise en charge.

The Li-Fraumeni syndrome (LFS) is an inherited form of cancer, affecting children and young adults, and characterized by a wide spectrum of tumors, including soft-tissue and bone sarcomas, brain tumours, adenocortical tumours and premenopausal breast cancers. In most of the families, LFS results from germline mutations of the tumor suppressor TP53 gene encoding a transcriptional factor able to regulate cell cycle and apoptosis when DNA damage occurs. Recently, germline mutations of hCHK2 encoding a kinase, regulating cell cycle via Cdc25C and TP53, were identified in affected families. The LFS working group recommendations are the following: (i) positive testing (screening for a germline TP53 mutation in a patient with a tumor) can be offered both to children and adults in the context of genetic counseling associated to psychological support, to confirm the diagnosis of LFS on a molecular basis. This will allow to offer to the patient a regular clinical review in order to avoid a delay to the diagnosis of another tumor; (ii) the 3 indications for positive testing are: a proband with a tumor belonging to the narrow LFS spectrum and developed before age 36 and, at least, first- or second-degree relative with a LFS spectrum tumor, before age 46, or a patient with multiple primary tumors, 2 of which belonging to the narrow LFS spectrum, the first being developed before 36 or a child with an adenocortical tumour; (iii) presymptomatic testing must be restricted to adults; (iv) the young age of onset of the LFS tumors the prognosis of some tumors, the impossibility to ensure an efficient early detection and the risk for mutation carriers to develop multiple primary tumors justify that prenatal diagnosis might be considered in affected families.

["Transparent circles" lymph glands: an unusual appearance on lymphography in certain proliferative lymphoid syndromes: prognostic value]. / Les ganglions "cerclés transparents". Aspect inhabituel de la lymphographie dans certains syndromes lympho-prolifératifs. Intêrêt pronostique.

The authors describe 27 cases in which a very particular type of lymphographic image was observed, associating disseminated lesions in all the retroperitoneal lymph glands, and an appearance of "circled" glands of very weak density. This image may be rarely observed in Hodgkin's disease and non-Hodgkin type hematosarcomas. It is frequently observed, however, during the course of angio-immunoblastic lymphadenopathy. Whatever the etiology, this image is of particularly poor prognostic significance.

[Study of the efficacy and tolerance of Iopamiron 370 compared to Telebrix Hystero in hysterosalpingography]. / Etude de l'efficacité et de la tolérance du Iopamiron 370 comparativement au Télébrix Hystéro au cours de l'hystérosalpingographie.

Hysterosalpingography is used to study the state of the uterine cavity as well as to analyse the patency of the tubes and the state of the tubal mucosa. It is difficult to find a contrast medium that has both the ideal qualities, be well tolerated and able to show fine pictures that have good contrasts, while at the same time are sufficiently viscous to allow up examination. The contrasts products that are used to carry out hysterosalpingography are often classed as viscous (Telebrix Hystero) and fluid (Iopamiron). This prospective randomised study compares local tolerance and efficiency of the two products. Fifty patients had Iopamiron and 48 Telebrix Hystero in July 1988 and February 1989. There was a statistical difference between the two groups which was significantly in favour of Iopamiron on the following features: Pain as noted on a questionnaire with steps of five points each (p = 0.02), Pain as described by the patient immediately after the examination on a visual analogue scale with p less than 0.01. Overall appreciation of the two products according to their tolerance and the efficiency of the products, which is to say the clearness of the pictures obtained with a p = 0.05.

[INSERM-FNCLCC collective expert's report. Recommendations for management of women having a genetic risk of developing breast and/or ovarian cancer. National Federation of Centers of the Fight Against Cancer]. / Expertise collective INSERM-FNCLCC. Recommandations portant sur la prise en charge des femmes ayant un risque d'origine génétique de développer un cancer du sein et/ou de l'ovaire.

BACKGROUND: Almost 10% of breast and ovarian cancer are inherited, and the majority are linked to BRCA1 and BRCA2 germline mutations. Despite the uncertainty, consensus guidelines were defined to assist practitioners', and patients' decisions about the health care decisions to be made. METHODOLOGY: The Ad Hoc Committee consisted of 14 experts designated by the French National Institute for Health and Medical Research. They all attended eleven workshops at which a systematic analytical review of more than 3500 articles was carried out. Five additional experts critically analyzed the first version of the report. PROCESS: Two thresholds were defined on a probability scale giving the risk of developing breast or ovarian cancer, to serve as a means of deciding as whether an intervention is worthwhile. The first threshold is that above which an intervention can be envisaged or recommended; the second is that under which an intervention can be ruled out; between the two, the decision has to be made on a each by case basis. SCREENING AND PREVENTIVE STRATEGIES ANALYZED: About breast cancer: 1) hormonal interventions; 2) primary prevention (diet, family planning and chemoprevention); 3) screening (breast self-examination, clinician breast examination, tumor markers, imaging); 4) prophylactic mastectomy. About ovarian cancer: 1) hormonal stimulation; 2) screening (clinical screening, ultrasound and tumor markers); 3) prophylactic oophorectomy. MAIN CONCLUSIONS: With each strategy the following points were dealt with: the information to be delivered to the consultant, the procedure and the indications. The Committee's opinion about BRCA mutation screening is that population-based or even large scale implementation are not justified. The Committee feels that specific management is indispensable and advocates the use of defined and evaluated procedures, and involvement in clinical trials.