This is the warning given by a “Draft decision” from the National Agency for Health Products (ANSM) to manufacturers. Seven brands of breast implants, “Likely to constitute a rare but serious danger” cancer in women while wearing, could be banned in France.
“In view of the scientific data acquired, national vigilance data, expert opinions and national and international recommendations from health professionals, it appears that breast implants with a macro-textured shell as well as breast implants covered with polyurethane present a risk “ of anaplastic large cell lymphoma, comments the agency in a letter revealed this Monday, March 25 by theAFP, relayed by France Info.
An official decision “soon”
“ANSM, as part of a risk reduction approach”, thus “The intention to prohibit the placing on the market, distribution, advertising and use” of seven brands of implants currently in use in France, according to the conclusions of the draft decision. The macrotextured prostheses concerned are those of the Biocell (Allergan) brand, already withdrawn from the market last December, LSA (Sebbin laboratory), Polytext (Polytech), Arion, Cristalline and Nagotex (GC Aesthetics group). Polyurethane-shell implants, from the Microthane brand (Polytech) are also in the sights of the agency.
The ban on all of these implants would go beyond the recommendations of the expert committee convened at the beginning of February by the ANSM, after the “Implant Files” affair. Its only mission was to comment on prostheses from the manufacturer Allergan, implicated in the occurrence of anaplastic large cell lymphoma. Patients, healthcare professionals and other stakeholders were interviewed, so that the committee could benefit from a global perspective on their use.
However, the sanitary gendarme warns : “No decision has been taken at this stage”. He must return ” shortly “ its official decision. “Any contrary information which could circulate must be considered as false and not validated by the ANSM”, he specifies.
Read also :
- Medical implants: system failures pointed out again
- Implants for the treatment of prolapse and urinary incontinence under surveillance
