The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.
- Allergan Natrelle BIOCELL Textured Products:
- Allergan Natrelle Saline-Filled Textured Breast Implants
- Allergan Natrelle Silicone-Filled Textured Breast Implants
- Allergan Natrelle® 410 Highly Cohesive Anatomically Shaped Silicone- Filled Textured Breast Implants
- Allergan Natrelle 133 Plus Tissue Expander
- Allergan Natrelle 133 Tissue Expander with Suture Tabs
- Lot numbers: All lots (for complete listing of all styles, see the FDA Safety Communication)
- Manufacturing Dates: July 25, 2014 - June 21, 2019
- Distribution Dates: September 14, 2014- July 24, 2019
- Devices Recalled in the U.S.: 246,381
- Date Initiated by Firm: July 24, 2019
Breast implants are used in both breast augmentation surgery (to increase the breast size) and in breast reconstruction (to replace breast tissue that has been removed due to cancer or trauma or that has failed to develop properly due to a severe breast abnormality). Breast implants may also be used in revision surgery to correct or improve the result of a primary breast implant surgery. Tissue expanders are used in breast reconstruction following mastectomy, treatment of underdeveloped breasts, and treatment of soft tissue deformities. The expander is intended for temporary (less than six months implantation under the skin (subcutaneous) or under the muscle (submuscular).
Reason for Recall
The FDA requested that Allergan recall all BIOCELL textured breast implants and tissue expanders marketed in the U.S. due to risk of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL), a cancer of the immune system. Based on the currently available information, the FDA's analysis demonstrated that the risk of BIA-ALCL with Allergan BIOCELL textured implants is approximately 6 times the risk of BIA-ALCL with textured implants from other manufacturers marketing in the U.S. and continued distribution of Allergan's BIOCELL textured breast implants would likely cause serious, adverse health consequences, including death, from BIA-ALCL.
Of the 573 worldwide reported total cases of BIA-ALCL, 481 patients are reported to have Allergan breast implants at the time of diagnosis. Of those cases, 12 deaths occurred in patients implanted with an Allergan breast implant at the time of their BIA-ALCL diagnosis.
Although Allergan Natrelle 133 and 133 Plus tissue expanders have not been associated with BIA-ALCL to date, both devices have the same Biocell texture. While tissue expanders are only indicated to be used for 6 months, to date there is no information on what duration of exposure to the Biocell texture may induce BIA-ALCL.
Who May be Affected
- Any patient undergoing cosmetic or reconstructive surgery using Allergan Natrelle BIOCELL textured products is exposed to the problem device
- Surgeons who have implanted Allergan Natrelle BIOCELL textured products
- Health care providers who treat patients with breast implants
What to Do
For patients who have no symptoms, removal of these or other types of breast implants is not recommended, due to the low risk of developing BIA-ALCL. However, if you have any questions, talk to your health care provider.
Medical interventions to reduce the risk of BIA-ALCL due to the use of Allergan textured implants include foregoing breast reconstruction or augmentation or using alternative breast implants or autologous tissue.
Allergan sent Urgent Medical Device Recall (Removal) letters to U.S. customers, including surgeons, instructing them to return all unused product to a third-party recall provider, Inmar RX Solutions, as described in the letter.
Allergan also mailed notification letters to patients in three separate campaigns.
For specific questions about the recalled products, contact the manufacturer, Allergan, at IR-Medcom@allergan.com or call 1-800-678-1605 option #2.
Full List of Affected Devices
The complete list of devices is included in the FDA Safety Communication from July 2019.
Note: McGhan BioDIMENSIONAL Silicone-Filled Biocell Textured Breast Implants Style 153 were evaluated in clinical studies, but never marketed. Therefore, they are not included as part of the withdrawn product. However, patients who participated in the clinical study may have them implanted.
- Medical Device Recall Database Entry
- Allergan Press Release: Allergan Voluntarily Recalls BIOCELL® Textured Breast Implants and Tissue Expanders
- FDA Press Release: FDA takes action to protect patients from risk of certain textured breast implants; requests Allergan voluntarily recall certain breast implants and tissue expanders from market
How do I report a problem?
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program either online, by regular mail or by FAX.