Allergan Will Recall Implants At FDA’s Request
The Food and Drug Administration (FDA) asked Allergan to recall their BIOCELL textured breast implants and tissue expanders because they have been associated with about six times the risk of developing breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) compared to other textured implants. Allergan agreed, telling the FDA it will recall those products from the worldwide market.
481 out of 573 unique, worldwide cases of BIA-ALCL involved Allergan implants at diagnosis time, the FDA said. 12 out of the 13 deaths in patients with BIA-ALCL with a known implant manufacturer had Allergan breast implants. There were a total of 33 patient deaths.
BIA-ALCL is a type of non-Hodgkin’s lymphoma, according to the FDA’s safety communication, which notes that it is an extremely serious diagnosis which can kill, especially when its diagnosis isn’t early or it’s not treated soon enough. The safety communication contains a complete list of affected products.
The primary symptoms of BIA-ALCL are swelling which persists and pain around the implant. Lumps and asymmetry can also be symptoms.Most cases of BIA-ALCL only appear years after implantation. The FDA recommends that the asymptomatic not remove the implants, but that those with the above symptoms or other changes see a doctor about it. Patients with diagnosed BIA-ALCL should have the implants and the surround scar capsules surgically removed, the FDA says. BIA-ALCL is typically successfully treated via surgery, but some patients may need radiation therapy or chemotherapy.
The FDA recommends that patients always keep records of the device manufacturer, implant model name and unique device identifier of any implant put in their body.
This isn’t the first FDA alert regarding BIA-ALCL. FDA alerts regarding BIA-ALCL have been issued in 2011 and 2017. The FDA said in the 2011 alert that it was aware of a link between breast implants and anaplastic large cell lymphoma. The 2017 report came after extensive research and noted a link between anaplastic large cell lymphoma and textured implants in particular.
A 2017 review found that the underlying mechanism behind implants causing ALCL is chronic inflammation around the implants causing the proliferation and activation of T-cells. It found that the risk of ALCL is the highest with the most aggressively textured implants. The BIOCELL textured implant surfaces are designed to minimize scar tissue and prevent slippage. Most breast implants used in the United States have a smooth surface, and only 10% of breast implants sold in the U.S. are textured.