The Australian Department of Health’s Therapeutic Goods Administration has issued an alert that proposes a regulatory action — which includes canceling, suspending or recalling textured — regarding breast implants after a review on its link with cancer.
The agency says that women with textured breast implants may be prone to breast implant-associated cancer, which is also known as breast implant-associated anaplastic large cell lymphoma (BIA-ALCL).
Mainly, BIA ALCL is a rare cancer of the immune system. It is not like breast cancer that forms from cells in the breast, but instead, cancer that grows in the fluid and scar tissue that forms around a breast implant. Less commonly, BIA-ALCL can take the form of a lump in the breast or the armpit.
In cases of BIA-ALCL, it occurs as soon as one year after the operation and as late as 37 years after the surgery. The average time to diagnosis is within eight years of the procedure.
The American Society of Plastic Surgeons stated that BIA-ALCL occurs most frequently in patients who have breast implants with textured surfaces. To date, there are not any confirmed BIA-ALCL cases that involve only a smooth implant. BIA-ALCL patients seem to have an allergic reaction to textured devices over many years.
As of April, the TGA had received 76 reports of anaplastic large cell lymphoma associated with breast implants in Australian women. Additionally, the Medicines and Healthcare products Regulatory Agency (MHRA) states it received 1,586 Adverse Incident Reports for breast implants between 2014 and May 2019.
Meanwhile, there have been 457 cases in the U.S. linked between textured breast implants and the disease since 2011. The US Food and Drug Administration confirms that out of the 457 reported cases, nine women have died.
The latest FDA statement says the risk of developing BIA-ALCL in women with textured breast implants ranges from 1 in 3,817 to 1 in 30,000.
In line with latest TGA report, countries such as France and Canada acted in April to remove individual textured implants from their markets.
In March, the FDA recognized that textured breast implants most likely cause BIA-ALCL, but the agency did not proceed on ultimately banning the product, noting it wanted to continue studying the disease and tracking cases.
“The FDA is increasingly concerned about the potential BIA-ALCL risk for women with certain textured breast implants. Our experts have been reviewing new information presented since the public advisory committee meeting in March. We intend to update the public shortly with the findings of our analysis,” the agency said.
But an NBC News investigation in partnership with the International Consortium of Investigative Journalists last fall reported that BIA-ALCL could be much more common and can be as high as one case out of every 1,000 women with breast implants.
The FDA said the implants available in Australia are different from those sold in the U.S., which complicates efforts to figure out the actual risks.
Breast implants are gel or fluid-filled pouches inserted in the breast area. Furthermore, they differ in their size, shape, filling, and surface characteristics. Most implants are either round or teardrop-shaped. They may be filled with saline (sterile saltwater) or with silicone gel. The surface of the implant may be smooth or rough (textured), and different implants may vary in the amount of irregularity of the texture.
Notably, breast implants are not lifetime devices and need to be replaced after 10 to 15 years.
Contrary to popular belief, people may get breast implants for many reasons apart from cosmetic enhancement. The procedure is also popular for reconstruction purposes for people who underwent breast surgery for breast cancer.
It’s estimated that of the 400,000 women who get breast implants each year, about one in 10 has textured implants.
As of the moment, the Australian agency has “no decision to suspend or cancel the relevant products at this time.” Adding that “the next steps are for the sponsors to respond to the TGA’s notification and invitation to comment by 24 July 2019. The TGA will, as a matter of priority, consider the sponsor’s submissions before reaching any decision on whether to proceed to the proposed regulatory action.”
The TGA has also detailed the list of products and information on textured implants on its website.