Some cosmetic surgeons in Australia have been given permission to use textured silicone breast implants despite recalls and bans in place, The Sydney Morning Herald reports.

Australia’s Therapeutic Goods Administration (TGA) has given six cosmetic surgeons permission to use Polytech breast implants in a total of 36 patients. Although these implants are banned for six months, doctors are able to apply to use unapproved devices on a case-by-case basis.

A spokesperson for the TGA reportedly said that “all applications have been approved subject to conditions about informed patient consent.”

The TGA has banned certain implants in an attempt to keep patients safe, but some cosmetic surgeons are not happy about it. Certain doctors have voiced opposition to the ban, saying it was based on bad science and a flawed review of the risks of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL).

These sentiments have prompted a barrage of applications from doctors wanting to use the banned implants. In response, the TGA has directed doctors to use a new information sheet when talking with patients about the banned implants. The information sheet reportedly outlines the ban and the reasons behind it.

“It is expected that your surgeon will have considered all of the alternative options … and have appropriate clinical reasons for considering unapproved breast implants for you,” the information sheet states.

Banned Textured Silicone Breast Implants

In September, the TGA announced that eight types of textured silicone breast implants would be recalled and banned for six months, aiming to give manufacturers the chance to address “a number of safety and performance concerns, according to The Sydney Morning Herald.”

The chief concern with textured silicone breast implants is BIA-ALCL. This rare form of lymphoma has been diagnosed in patients with textured silicone breast implants. BIA-ALCL does not form in the breast tissue but in the scar capsule that surrounds the implant during the healing process.

Some 107 women in Australia have been diagnosed with BIA-ALCL and five women have died. Although the cancer has been documented for over a decade, research on the disease and regulatory actions have only come into prominence within the last few years.

Though the TGA’s six-month ban is intended to protect consumers, some researchers have theorized that BIA-ALCL may actually have nothing to do with breast implants. A study published in the Aesthetic Surgery Journal questions whether or not a lack of training in doctors is a risk factor for the cancer.

Doctors are reportedly able to call themselves cosmetic surgeons without acquiring certain credentials since the specialty is not recognized by the Australian Medical Council.

Gazi Husain, president of the Australian Society of Plastic Surgeons, says that “if a woman goes to see a cosmetic doctor for breast implants, she at least needs to know whether this person is a GP with an interest in performing cosmetic surgery and is legally allowed to perform the procedure, but they are not a surgeon.”

Requiring stricter guidelines for cosmetic surgeons may be a future step in preventing BIA-ALCL if a lack of skills is shown to be a risk factor for the rare disease.

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This article is not legal advice. It is presented
for informational purposes only.