[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.

[Identification and management of hereditary breast-ovarian cancers (2004 update)]. / Identification et prise en charge des prédispositions héréditaires aux cancers du sein et de l'ovaire (mise à jour 2004).

BACKGROUND: Since the last recommendations, up to 2500 new references had been published on that topic. METHODOLOGY: On the behalf of the health Minister, the Ad Hoc Committee consisted of 13 experts carried out a first version revisited by five additional experts who critically analyzed the first version of the report. MAIN UPDATING: Breast and ovarian cancer seem to be associated with fewer deleterious mutations of BRCA1 and BRCA2 than previously thought. The screening of ovarian cancer is still not an attractive option while in contrast MRI may be soon for these young women with dense breast, the recommended option for breast cancer screening. The effectiveness of prophylactic surgeries is now well established. French position is to favor such surgeries with regard to a quality of life in line with the expected benefit, and providing precise and standardized process described in the recommendation. CONCLUSIONS: Due to methodological flaws, the low power and a short follow-up of the surveys, this statement cannot however aspire to a high stability.

[Mammary implants and breast cancer]. / Implants mammaires et cancer du sein.

Many publications deal with the impact of cosmetic breast implants to increase the breast cancer occurence or to delay its diagnosis. We first try to express the clinical and radiological differences in the implanted breast. The diagnostical and therapeutical difficulties were developped to the different technics of imagery, biopsy and specific management of the treatment. On one hand, the litterature revue does not show any significant difference in tumoral stage and nodal status between augmented and nonaugmented women eventhough the mammography sensibility is not as optimal. On the other hand, the global mortality of the augmented population is higher but it appears that this phenomenon could be link to their way of life and is totally independant of breast cancer. Finally, if the diagnosis and the treatment are more complex, the women survival is not altered by breast augmented surgery.

[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.

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.

[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.

[INSERM-FNCLCC collective expertise. Recommendations for medical management of women with genetic risk of developing breast and/or ovarian cancer]. / Expertise collectice 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 in the management of women gene carriers, 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 analysed the first version of the report. CRITERIA AND DECISION 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. 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. In addition, the Committee's opinion about BRCA1 and BRCA2 mutation screening is that population-based or even large scale implementation are not justified. Although no scientific evidence is available, the Committee feels that specific management is indispensable and advocates the use of defined and evaluated procedures, and involvement in clinical trials.

[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.

Recommendations for medical management of hereditary breast and ovarian cancer: the French National Ad Hoc Committee.

BACKGROUND AND PURPOSE: Almost 10% of breast and ovarian cancers are familial, and the majority are linked to BRCA1 and BRCA2 germline mutations. Despite uncertainty about the management of female gene carriers, consensus guidelines have been established to assist practitioners and consultees in making health care decisions. METHODOLOGY: The Ad Hoc Committee was composed of 14 experts appointed by the French National Institute for Health and Medical Research, all of whom attended eleven workshops at which more than 3500 articles were systematically analyzed. Five additional experts critically analysed the first version of the report. CRITERIA AND DECISION PROCESS: On a probability scale of the risk of developing breast or ovarian cancers, two thresholds were defined for use in determining whether an intervention would be worthwhile. The first is the threshold above which an intervention can be envisaged or recommended, and the second is the one below which an intervention can be ruled out; between the two, the decision has to be made on a case-by-case basis. SCREENING AND PREVENTIVE STRATEGIES ANALYZED: With respect to 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. With respect to ovarian cancer: 1) hormonal stimulation; 2) screening (clinical screening, ultrasound and tumor markers); 3) prophylactic oophorectomy. MAIN CONCLUSIONS: For each strategy the following points were addressed: the information to be given to the consultee, the procedure and the indications. In addition, the committee's opinion about BRCA1 and BRCA2 mutation screening is that population-based, or even large-scale, implementation are not justified. Although no scientific evidence is available, the committee feels that specific management is indispensable and advocates the use of defined and evaluated procedures, and participation in clinical trials.

[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.

[Internal supporting mammary lamina. Results of the detection of breast lesions]. / Les "soutiens-gorge internes". Conséquences sur le dépistage des lésions mammaires.

In order to stabilize the curves of a surgically remodelled breast, Bustos associated to a periareolar mammaplasty a synthetic internal supporting lamina. At the beginning, in 1985, a smooth perforated silicone sheet was used. Since then, other materials were proposed (radioopaque ou radiotransparent, resorbable or not). Because of their superficial situation, in front of the mammary gland, it was essential to study the consequences of the presence of such a material on the mammographic follow-up. We radiographied all the different types of sheet in vitro, and also in vivo, 3 to 19 months after surgery. At the same time we studied the modifications in the breast tissue, in 117 patients after surgical treatment for ptosis or mammary hypertrophy, using different kinds of incisions (periareolar or anchor-shaped, J or L shaped, inferolateral oblique or lower vertical incisions). We also studied the effects of mammary implants covered with Dacron, since some internal mammary supporting lamina are made with this material. The silicone sheet gives some artifacts and may calcify. The resorbable sheet has no effects on the mammography. The radiotransparent non resorbable ones causes no problems on short terms, but we are not sure whether some calcifications appear on long term or not.