Breast implants with textured surfaces prohibited

We were waiting for his decision. The verdict is in: in a press release published this Thursday, April 4, the National Agency for the Safety of Medicines and Health Products (ANSM) announces the withdrawal from the market of macrotextured breast implantsand those with a surface covered with polyurethane. This decision taken “as a precautionary measure” aims to “reduce the risk of anaplastic large cell lymphoma associated with breast implants (ALCL-AIM)”.

AIM ALCL is a rare type of T-cell lymphoma, a rare but very aggressive cancer. The health agency investigated a possible link between the occurrence of this disease and textured breast implants, after the report of cases of LAGC AIM. It concludes that the risk remains “rare but serious” hence its decision to prohibit certain macrotextured implants with a texture equivalent to Allergan’s Biocell envelope and polyurethane. “In view of all the information available to it, including the opinions of independent experts, the ANSM considers that the texturing of certain macrotextured implants and implants with a surface covered with polyurethane constitutes a risk factor in the appearance of ALCL -AIM”, underlines the health constable in his opinion.

The controversy surrounding the safety of breast implants textures has grown since the reported cases of AIM ALCL in breast implant recipients. As of 2011, 59 cases of anaplastic large cell lymphoma associated with breast implants (LAGC-AIM) have been declared in France.

In its conclusions, the ANSM considers that “the more the implant is textured and rough, the greater the risk of occurrence of LAGC-AIM is important”. The health agency recommends preferably using smooth breast implants in cosmetic or reconstructive surgery.

The decision to withdraw from the French market and to prohibit the marketing, distribution and use of this type of breast implant takes effect on April 5, 2019.

No preventive explantation for carriers of these implants

In view of the rarity of the risk of LACG, the ANSM wishes, however, to reassure carriers of textured breast implants with a surface covered with polyurethane: it does not recommend preventive explantation.

To candidates for the placement of breast implants, the drug agency recalls the importance of being informed about “the advantages and disadvantages of the various implants available and alternative techniques in cosmetic surgery or reconstruction after breast cancer”. Before the placement of implants, all women must receive a document “mentioning in particular the identification of the surface of the implant (smooth, micro-textured…), its limited lifespan and the possible need for a resulting re-intervention as well as the medical follow-up”.

400,000 women have breast implants in France (2017 figure), according to the ANSM.

For more information, a toll-free number is available on 0800 71 02 35 (free call Monday to Friday from 9 a.m. to 7 p.m.).

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