Allergan Breast Implant Recall Statement from PSANJ

Allergan Breast Implant Recall Statement from PSANJ

First and foremost, PSANJ is committed to the safety and wellbeing of all of our patients. In that vein, we wanted to communicate to all patients that recently, the FDA has announced a recall of textured implants by the manufacturer Allergan. The cause of the recall was for concern over breast implant- associated anaplastic large cell lymphoma (BIA-ALCL). While the risk of this is very small, it has been associated with the texturing of the implants listed above. As a precaution, Allergan also voluntarily recalled their textured tissue expanders and replaced them with smooth expanders. The vast majority of our patients for both reconstructive and cosmetic breast surgery have had smooth implants used. There is a very small number of patients with textured implants in place. These patients will soon be receiving a letter informing them of their options moving forward. Officially, the FDA has not recommended removal of these implants if already in place.

Until recently, textured expanders were used in our reconstructive patients. Smooth expanders have been used since they became available. Tissue expanders are a temporary device typically in place for 3-12 months. There have been no associated cases of BIA-ALCL with textured tissue expanders. The average time of onset for BIA-ALCL in textured implants is 9 years. The tissue expander recall was a voluntary action taken by Allergan.

At the time of your surgery, you were given a card with your implant information which can be used to tell if you have textured or smooth devices. We would be happy to check our records for you as well. If we no longer have your implant information, you may call Mentor or Allergan to track your implants through the manufacturer with your name and birthdate.

PSANJ would like to reiterate that the risk of BIA-ALCL is very low. The number of reported cases worldwide is 573 cases. We have included a link to the FDA new release regarding the recall and information on BIA-ALCL for your review.

We are happy to speak with any patients who may have questions or concerns about BIA-ALCL.

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