Breast implants: France bans designs linked to rare cancer

International health authorities now recognize that implants with roughened surfaces — both gel-filled and saline-filled — can cause a very rare lymphoma a type of immune system cancer. Since the FDA first issued a warning in 2011 nearly 700

International health authorities now recognize that implants with roughened surfaces — both gel-filled and saline-filled — can cause a very rare lymphoma a type of immune system cancer. Since the FDA first issued a warning in 2011 nearly 700

Allergan, the company that manufactures the implants, did not immediately respond to a request for comment.

Health Canada made the announcement with a notice to Allergan, the maker of the implants, that it would suspend licenses for Biocell breast implants "as a precautionary measure".

The Canadian agency has banned only Allergan's Biocell breast implants. The agency has yet to announce any regulatory response. The malignancy is technically called breast implant-associated anaplastic large cell lymphoma (BI-ALCL). The French safety agency had asked for additional data on the implants, but the company said it could not provide it before the expiration date. FDA responded to the flurry of global activity with a statement saying it intends to communicate which actions, if any, it plans to take "in the coming weeks", noting that meeting participants "expressed varying views on banning textured implants, without consensus".

France has become the first country to ban a type of breast implant that has been linked to a rare form of cancer that attacks the immune system, the media reported on Friday.

One retrospective study published by University of British Columbia plastic surgeons in 2018 found Biocell implants had the shortest time to explantation and the highest rate of implant performance failure.

The Canadian regulator initiated the review because of an increase in Canadian and worldwide cases of BIA-ALCL, it said.

The regulators said if they did not receive satisfactory new evidence from Allergan within 15 calendar days, they intend to revoke marketing authorization for Biocell devices.

Thus, the ANSM takes the decision, as a precautionary measure, to withdraw from the market some macro textured implants of texture equivalent to the Allergan Biocell envelope and polyurethane to reduce the exposure of women to the risk of BIA-ALCL which remains a rare but severe risk, it added.

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Health Canada said its complete breast implant safety review will be available by the end of this month, and the agency "will not hesitate to take further action, as necessary".

France also announced that it intends to ban textured breast implants earlier this week.

"The more the implant is textured and rough the greater the risk of BIA-ALCL", it said.

The ban covers several models from USA manufacturer Allergan that had already been withdrawn from sale in December as well as similar models from France's Arion and Sebbin, Britain's Nagor and Eurosilicone and German's Polytech.

France was at the centre of a major scandal involving implants in 2010 after it emerged that the maker of a popular brand of implants had been filling them with a cheap industrial-grade silicone gel, which was more unsafe for wearers than medical-grade silicone.

Health Canada says it is aware of 28 confirmed cases of the lymphoma in Canada.

The ANSM, however, did not recommend that the women who had received the implants undergo surgery to have them removed, because of the "rarity of the risk", it said.

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