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Australian regulators are calling for a ban on textured breast implants, due to a risk that they may cause women to develop a rare form of cancer known as breast implant-associated anaplastic large cell lymphoma (BIA-ALCL).
The proposed textured breast implant ban came in a press release issued by Australia’s Therapeutic Goods Administration (TGA) on July 11.
The decision stems from a review of breast implants sold in that country, which began in May. At that time, TGA investigators said they planned on taking more than 2,000 sets of measurements on more than 150 samples, as well as conducting a statistical analysis of all known cases of BIA-ALCL.
At least 78 cases of cancer from textured breast implants have been confirmed among Australian patients, including at least four deaths, according to the TGA.
“Based on the laboratory and statistical review, the TGA has proposed regulatory action in relation to a number of textured implants only,” the press release states. “Those proposed regulatory actions are either a proposal to cancel or a proposal to suspend.”
The TGA notes that no final decision has been made, and that sponsors of the products that would be banned have the opportunity to respond and comment by July 24. The agency will then weigh those responses in its final deliberations.
The breast implant ban would affect Allergan’s Natrelle line of textured breast implants. The licenses for a number of other breast implants, including Johnson & Johnson’s Siltex implants Mentor CPX 4 Breast Tissue Expanders, among other products, would be suspended. Suspension means the products could no longer be imported, manufactured or exported from Australia for the duration of the suspension.
The suspensions indicate that the TGA thinks it likely the products will eventually be banned as the review continues. A full list of breast implants that would be suspended or banned is available in the press release.
All of the breast implants would be recalled if they have not yet been implanted. The TGA is not recommending that women have the implants surgically removed unless they are causing health problems, such as BIA-ALCL.
If the ban goes forward, Australia would be the third major country to ban textured breast implants.
In April, French health officials announced a macrotextured breast implant recall and ban in that country, saying that textured breast implants have been overwhelmingly associated with BIA-ALCL in that country and provide little to no benefit over smooth surfaced implants.
At about the same time, Canadian health officials made a similar decision, banning all Allergan Biocell breast implants in that country after linking the devices to 86% of BIA-ALCL cases in that country.
However, in the United States, the FDA recently decided against a complete textured breast implant recall, indicating the design makes up only a small number of U.S. sales. The agency also noted that it has found cases of BIA-ALCL linked to smooth textured implants as well, opting to require the manufacturers to place a stronger warning on the products instead of banning textured implants.
Breast Implant Cancer Risks
The FDA first warned about case studies and epidemiological research that suggested there was a link between breast implants and ALCL in January 2011. Several years later, in 2017, the agency issued an updated statement about emerging information on breast implant lymphoma problems, and a number of subsequent studies have confirmed the risk of breast implant-associated ALCL.
In June 2017, a study published in the medical journal Plastic and Reconstructive Surgery suggested that certain textured breast implants may increase the risk of anaplastic large cell lymphoma anywhere from 10 to 14 times, when compared to smooth breast implants. Another study, published in October 2017, warned that many breast implant cancer cases worldwide have likely not been reported, and noted that doctors and patients may not be aware of BIA-ALCL.
In March 2018, the FDA indicated that it was aware of more than 400 cases of breast implant-related cancer. A year later, in March 2019, the FDA held a two-day hearing on breast implant safety and benefits, revealing that it has received tens of thousands of reports of breast implant complications.