Three categories of medical devices are concerned by this assessment :
1. External breast prostheses
Indications are as follows: total mastectomy, congenital or acquired asymmetry, major hypoplasia and aplasia. The HAS Committee for the Assessment of Products and Services (CEPP) recommends that external silicone prostheses, whether adhesive or non-adhesive, continue to be reimbursed, and that there be a specific reimbursement procedure for textile prostheses, which are not currently reimbursed by the French national health insurance. The CEPP no longer recommends reimbursement of external fluid-filled prostheses, given the other available prostheses types. Distribution procedures for all external prostheses have also been given, including the requirement for specific training for distributors, availability of samples of each type of external prosthesis, obligation to try the product before delivery, and making sure premises are equipped to maintain patient privacy.
2. Tissue expanders
The use of expanders differs according to the indications : mammary or non-mammary indications. The CEPP recommends that tissue expanders continue to be reimbursed.
3. Breast implants
It is confirmed that breast implants have actual clinical benefit in breast reconstruction and breast augmentation that are reimbursed by the French national health insurance. Implants used for cosmetic surgery are not recommended for reimbursement by the French national health insurance.
Joint technical specifications have been drawn up, which include the requirements of European standard NF EN ISO 14607 on breast implants. The shape, filling and cover texture of reimbursed implants have also been specified, and reimbursement is limited to implants containing saline and/or silicone gel.
This project has updated device categories, based on new data from the literature and on clinical practice.
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