Textured breast implants sold by a major pharmaceutical firm exposed Australian women to a higher risk of cancer and should never have been sold to the public, a lawsuit claims.
Allergan, one of the manufacturers of these now-banned implants, could be facing a hefty damages bill after a class action lawsuit was filed in the Federal Court in November.
The lawsuit claims patients suffered pain, distress and disappointment as well as additional medical costs by having surgery to insert the implants, and in some cases, remove or replace them.
A number of textured breast implants have been removed from the Australian Register of Therapeutic Goods due to perceived safety risks, including those sold by Allied Scientific Products, Emagin, Euro Implants and JT Medical.
In August 2019, Allergan announced a voluntary worldwide recall of its own BIOCELL products.
At the time, the firm, which is owned by AbbVie, cited data from the US Food and Drug Administration that showed a higher occurrence of breast implant-associated anaplastic large cell lymphoma in patients who had these implants.
This cancer can be treated by removing the implants, removing the surrounding scar tissue and, in some cases, radiotherapy or chemotherapy, court documents seen by AAP claim.
Allergan's macro-textured implants were "were significantly more likely" than alternative products to cause this type of immune system cancer, the documents say.
The medical devices are used for breast augmentation, reconstruction or reduction, as well as for chest feminisation.
The class action, which is being led by William Roberts Lawyers, alleges the implants were not of acceptable quality and had defects that breached Australian consumer guarantees.
The lead plaintiff in the lawsuit had her implants inserted in February 2017 and opted to have them replaced in June 2024 with non-Allergan products.
The type of lymphoma associated with these medical products typically involves a swelling of the breast around eight years after an operation, the Therapeutic Goods Association (TGA) said in a statement when Allergan announced its recall.
The cancer was rare, the government entity said, with experts estimating the risk lay between one-in-1000 and one-in-10,000.
"The TGA has been advised that removal or replacement of macro-textured breast implants or tissue expanders in asymptomatic patients is not recommended," it wrote.
An AbbVie spokeswoman declined to comment on the lawsuit.
