“ a mastectomy bra which is worn by post operated women following amputation of a breast or breasts. The bra is especially designed to hold silicone breast forms and has left and right pockets to hold the breast forms firmly in place. The other design features which differentiate the mastectomy bra from an ordinary bra are the wide padded straps which help support the weight of the breast form and help to avoid undue stress associated with neck/shoulder problems for the post operated women. The bra is also designed to ensure the breast form itself does not show and therefore has a specific cut and shape dissimilar to a conventional bra”
“First, the intended use and the material composition of the article must be precisely determined. Next, in the light of the wording of the headings of the relevant sections and chapters a provisional classification must be undertaken according to the article’s intended use and material composition. There must then be considered whether on a combined examination of the wording of the headings and the explanatory notes to the relevant sections and chapters a definitive classification may be reached. If not, then in order to resolve the conflict between the competing provisions recourse must be had to Rules 2-5 of the General Rules. Lastly, classification must be made under the sub-headings. “Classification must proceed on a strictly hierarchical basis taking each level of the CN in turn. The wording of one heading can be compared only with the wording of another heading; the wording of a first sub-heading can be compared only with the wording of other first sub-headings on the same heading; and the wording of a second sub-heading can be compared only with the wording of other second sub-headings of the same first sub-heading. “In this exercise the wording of the headings and the explanatory notes of the CN are to be interpreted so as to be consistent with the Harmonised System. The Court has consistently held that the explanatory notes drawn up, as regard to the Harmonised System, by the World Customs Organisation, may be an important aid to the interpretation of the individual tariff headings, although they do not have legally binding force.”
“Articles of apparel and clothing accessories not knitted or crocheted.”
“Brassieres, girdles, corsets, braces, suspenders, garters and similar articles and parts thereof, whether or not knitted or crocheted”
“brassieres of all kinds”
“This chapter does not cover: …(b) orthopaedic appliances, surgical belts, trusses or the like (heading 9021)”
“Optical, photographic cinematographic, measuring, checking, precision, medical or surgical instruments and apparatus, parts and accessories thereof.”
“Orthopaedic appliances, including crutches, surgical belts and trusses; splints and other fracture appliances; artificial parts of the body; hearing aids and other appliances which are worn or carried, or implanted in the body, to compensate for a defect or disability.” 9021 29 00 - - other 9021 39 - - other 9021 39 10 - - - Ocular prostheses 9021 90 90 - - other 9021 in the Combined Nomenclature applies to “orthopaedic appliances, including crutches, surgical belts and trusses; splints and other fracture appliances; artificial parts of the body; hearing aids and other appliances which are worn or carried, or implanted in the body, to compensate for a defect or disability”
“In order to achieve optimum weight compensation, the so-called regular weighted silicone was developed to copy the weight of the natural breast.”
“it is inherent in the product, and such inherent character must be capable of being assessed on the basis of the products objective characteristics and properties.” “In this case, as the Advocate General observed in paragraph 48 of her opinion, the polydimethisloxane (the product being considered) could be classified either as according to its essential characteristics or according to its objective purpose under one of [four different] headings of the CN.”
“This is considered to reduce the likelihood of lymphedema (sic) formation on the side of the operated breast.”
“The use of external prostheses, however, can lead to discomfort for the patients through shoulder pain and muscle hardening. It can be assumed that this is caused by strain on the shoulder due to the weight of the prosthesis”
“After mastectomy restoration of body symmetry, a very important aspect of coping with daily life, may be achieved either using breast forms that are suspended in a brassiere or by a new system in which breast forms are attached by adhesive strips to the thorax wall. The system promises free and easy movement, favourable effects on lymphoedema, and improvements with respect to dressing. Brassieres are not necessarily needed. The influence of improved prosthetics on patients self concept and wellbeing was investigated. A group of 67 patients after unilateral mastectomy tested custom breast forms and self-adhesive breast forms. … Most patients were better satisfied with epicutaneous self-adhesive breast forms. … Breast reconstruction became less important for 62%. The new concept of self-adhesive breast forms is an improvement with respect to social and physiological rehabilitation.”
“Using the mastectomy bra, lymphoedema, wrong body postures and muscular misuse can be avoided”; c) an opinion from Doctor Munstedt (the co-author of two of the papers sighted above) who was asked to comment on the differences between an orthopaedic bra after mastectomy and an ordinary bra. He refers to the beneficial effects of bras with specific features after sternotomies, i.e. cardiac surgery and in cases of breast pain not related to a mastectomy. He also considers the question which is for the Tribunal, namely if special bras for patients after mastectomies can be regarded as orthopaedic appliances and if they are primarily designed to compensate for a defect or disability. He considers them to be “more advantageous compared to conventional bras which mainly or exclusively have aesthetic purposes”
“… instrument, apparatus, appliances, material or other article, whether used alone or in combination, … the purpose of: - diagnosis, prevention, monitoring, treatment or alleviation of disease, - diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap, …”
“The supply to a handicapped person for domestic or his personal use, or to a charity for making available to handicapped persons by sale or otherwise, for domestic or their personal use, of – (a) medical or surgical appliances designed solely for the relief of a severe abnormality or severe injury.”