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Textured Implants Recall

Premier Plastic Surgery just received an important message from the FDA and I wanted to bring my patients up to date with a recall of Allergan Natrelle BIOCELL Textured Products due to the risk of breast implant associated anaplastic large cell lymphoma (BIA-ALCL). By recall, the FDA has determined that these implants should no longer be distributed for sale in the United States. However, the FDA does not recommend the prophylactic removal of textured implants in patients who have them but are not having any symptoms.

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Textured Implants Facts

Textured implants have been associated with the development of BIA-ALCL as first reported in 1997. Although BIA-ALCL has been reported in 30 patients with smooth implants at the time of diagnosis, there have been no cases reported in patients in which smooth implants were used exclusively in which the complete implant history of the patient was known. (1)

In the 573 patients who have developed BIA-ALCL worldwide, 481 of those patients had an Allergan breast implants at the time of diagnosis. Of those cases with Allergan breast implants, there have been 12 deaths. (2)

Although there has been no single cause for the development of BIA-ALCL, it is thought to be due to the initiation of a chronic inflammatory process due to contamination of the implant with bacteria, resulting in a biofilm and T – cell hyperplasia. ALCL specimens have grown out a gram negative organism, Ralstonia pickettii. It appears that the risk of the development of BIA-ALCL is correlated with the degree of texturization of the implant. (1)

The most common presenting symptom is a fluid collection in the breast, i.e. a seroma, followed by breast pain or swelling. (1) If you have any of these symptoms and have textured implants, you should seek medical attention, right away.

Due to the above, we avoid the use of textured implants altogether.

For more Information

If you want to learn more about the recall, please click here.

 

  1. Modern Primary Breast Augmentation: Best Recommendations for Best Results; Wan D, Rohrich R; Plast Recon Surg, 142 (6); pp 933e – 946e, 2018
  2. FDA, Allergan Recalls Natrelle Biocell Textured Breast Implants Due to Risk of BIA-ALCL Cancer, https://www.fda.gov/medical-devices/medical-device-recalls/allergan-recalls-natrelle-biocell-textured-breast-implants-due-risk-bia-alcl-cancer, Sep (2019).