Drs. High want to express their gratitude for your continued confidence in them as your physicians and surgeons. As a practice, we want to keep you informed of voluntary recall for Allergan BIOCELL® TEXTURED breast implants.
Allergan, the largest manufacturer of breast implants in the world, announced a voluntary recall of TEXTURED implants.
Allergan makes both smooth and TEXTURED implants. This global recall only applies to Allergan’s TEXTURED implants. These products have a BIOCELL TEXTURED shell, which is a unique surface used only by Allergan.
Allergan is taking this action as a precaution after the recently updated global safety information concerning the correlation between this implant’s TEXTURED surface and the uncommon incidence of Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL) provided by the FDA.
The occurrence of this illness is extremely rare and is only associated with TEXTURED implants.
At this time there is no recommendation to remove implants already in place; the recall is on further production of the TEXTURED devices.
The FDA and other health authorities do not recommend the removal or replacement of TEXTURED breast implants or TEXTURED tissue expanders unless you are experiencing symptoms of BIA-ALCL.
The FDA’s recommendations, along with updated data on BIA-ALCL can be seen here:
The ASPS recommendations can be seen here:
Please click here to read the Letter from Allergan for detailed information on TEXTURED implant replacement and warranty coverage.
If you have any questions or concerns, please contact our office at (919) 872-2616.