The health authorities of France and Canada announced Thursday that they have suspended the sales of certain breast implants due to the risk of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL).
The suspension of sales comes after a U.S. advisory panel late last month called for the U.S. Food and Drug Administration to consider additional post-market data reporting requirements on breast implant manufacturers. As of now, however, the U.S. did not issue any suspension of sales for breast implant products as the panel had noted that the data is lacking to support such a recommendation.
In Korea, the Ministry of Food and Drug Safety issued a safety information disclosure based on the FDA in February.
When asked about if the agency plans to suspend sales of certain breast implants similar to the announcements made from its foreign counterparts, the ministry said that it is aware of the situation and is reviewing the matter internally.
“Although there are no immediate plans to suspend sales of any breast implant product in Korea, we are closely monitoring the situation,” a ministry official told Korea Biomedical Review. “If a decision is made we will post the results on our website.”
In France, National Agency for the Safety of Medicines and Health Products (ANSM) halted the marketing, distribution, and use of macro-textured breast implants and polyurethane-coated breast implants produced by six manufacturers – Allergan, Arion, Sebbin, Nagor, Eurosilicone and Polytech.
“Since 2011, 59 cases of anaplastic large cell lymphoma associated with breast implants (LAGC-AIM) have been reported in France,” the French agency said. “Given this opinion and all the information available to it, the ANSM considers that the more the implant is textured and rough, the greater the risk of occurrence of BIA-ALCL is important.”
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.
The Canadian agency has banned only Allergan’s Biocell breast implants.
“To protect Canadian patients from the rare but serious risk of BIA-ALCL, Health Canada is advising Allergan that the department intends to suspend its licenses for Biocell breast implants as a precautionary measure,” Health Canada said. “This follows the completion of Health Canada's scientific assessment of macro-textured implants, as part of its larger ongoing safety review of breast implants and BIA-ALCL, which was launched in November 2018.”
The Canadian regulator initiated the review because of an increase in Canadian and international cases of BIA-ALCL, it said.
The agency added that a total of 28 confirmed cases of BIA-ALCL had been reported, of which 24 (86 percent) involved Allergan's Biocell breast implant.
“The entirety of Health Canada's safety review of breast implants and BIA-ALCL will be available by the end of April. Health Canada will not hesitate to take further action, as necessary,” the agency noted.
Allergan will have 15 days to respond with new evidence to Health Canada’s decision and If the answer is not satisfactory the agency will suspend the medical device license for Biocell.
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