For detailed indications, contraindications, warnings, and precautions associated with the use of all MENTOR® Implantable Devices, which include MENTOR® Saline-filled Implants, MemoryGel® Implants, MemoryShape® Implants, ARTOURA™ Expanders, and CONTOUR PROFILE® Expanders, please refer to the Instructions for Use (IFU) provided with each product or visit www.mentorwwllc.com.
The current lifetime risk of BIA-ALCL in the U.S. is unknown, but estimates have ranged between estimated to be between 1 in 70,000 to 1 in 500,000 women with breast implants according to MD Anderson. Certain geographic locations have demonstrated variable risks. For instance, a December 2016 update from the Therapeutic Goods Administration of Australia and New Zealand reported a risk of 1:1,000 to 1:10,000 for textured implants.". To date (2017), there has not been a case of BIAL reported where the patient had only implantation of smooth shell breast implants or a textured tissue expander that was exchanged for a smooth implant. The paucity of cases reported in Asian populations has raised the possibility that there may be a range of genetic susceptibility to the phenomena, or alternatively merely reflect differences in how cases are identified and reported.