Australian regulators are cracking down on textured breast implants, amid concerns that they may be causing some women to develop a rare form of cancer called anaplastic large cell lymphoma, or ALCL.
According to the Therapeutic Goods Administration (TGA), at least 100 Australian women with textured breast implants have been diagnosed with ALCL, including four who died. More than 700 breast implant lymphoma cases and 23 deaths have been confirmed worldwide.
The TGA is suspending sales of eight different types of textured breast implants for the next six months, so these safety concerns can be addressed.
“This means that these devices will not be able to be imported, exported, or supplied within Australia while the TGA works with industry sponsors to ensure the devices meet all the necessary requirements for patient safety,” the regulator said in a statement dated September 26th. “Any stock of these un-implanted devices in the market will also be recalled during the suspension period. No models of breast tissue expanders have been suspended.”
Once they become aware of a new breast implant lymphoma case, device manufacturers must now file a report with the TGA within 10 working days.
Breast implant-associated ALCL is not breast cancer, but a form of non-Hodgkin’s lymphoma that develops in the scar capsule surrounding breast implants. Symptoms include:
Fortunately, breast implant lymphoma is a slow-growing and highly treatable cancer IF DETECTED EARLY. Treatment generally includes removal of the breast implants and surrounding tissue. However, if the cancer has spread beyond the scar capsule, chemo and radiation may also be necessary.
Roughly 93% of patients who undergo treatment for breast implant lymphoma remain disease free three years later. When deaths have occurred, diagnosis and treatment were delayed an average of two years after symptoms first appeared.
Over the summer, Allergan Inc. announced a worldwide recall for Biocell textured breast implants and tissue expanders, at the request of the U.S. Food & Drug Administration (FDA). These devices were implicated in the majority of breast implant lymphoma cases confirmed by the agency, as well as 12 of the 13 deaths in which a manufacturer could be identified.
According to the FDA, there’s no reason to have Biocell textured breast implants removed in the absence of lymphoma symptoms. Instead, recipients of the recalled devices should monitor their implants for any changes, especially persistent swelling or pain in the vicinity of the breast implant, and immediately report any concerns to their doctor.