Medical device-maker Allergan is recalling one of its breast implants two weeks after Australia's regulatory body recommended banning the product because of a link to a rare form of cancer.
Subscribe now for unlimited access.
$0/
(min cost $0)
or signup to continue reading
The Therapeutic Goods Administration's proposed regulatory action on July 11 followed a review of an apparent association between anaplastic large cell lymphoma and some implants.
Allergan Australia said then it was reviewing the TGA action in relation to its Natrelle Biocell textured breast implants and tissue expanders.
On Wednesday, Allergan issued a worldwide recall for the implants.
The US Food and Drug Administration said it called for the removal after new information showed Allergan's Biocell breast implants account for a disproportionate share of rare lymphoma cases, The Associated Press reported.
The FDA is not recommending women with the implants have them removed if they are not experiencing problems.
France and Canada acted in April to remove certain textured implants from their markets.
As of April, the TGA had received 76 reports of anaplastic large cell lymphoma associated with breast implants in Australian women.
The estimated risk of breast implant associated lymphoma is between one-in-1000 and one-in-10,000.
Experts do not recommend removal of breast implants where there are no problems with the implant.
Legal firm Slater and Gordon revealed it is considering a class action against Allergan Australia.
The firm's Andrew Baker said a few dozen women who have the implants and the rare cancer have contacted the firm and a decision would be made about a class action in coming months.
Australian Associated Press
