Allergan Issues Recall of Textured Breast Implants and Tissue Expanders Amid Potential Link to Cancer
UNITED STATES – According to an online news article published by www.today.com, Allergan recalled its BIOCELL textured breast implants and tissue expanders following reports of women being diagnosed with cancer, with some cases resulting in death.
Allergan, a medical device manufacturer, has recalled all its BIOCELL textured breast implants and tissue expanders, removing the products from the market. The recall was announced after the United States Food and Drug Administration (FDA) reported a significant increase in the number of cases of women with Allegan’s BIOCELL textured breast implants who have been diagnosed with breast-implant associated anaplastic large cell lymphoma (BIA-ALCL), a type of non-Hodgkin’s lymphoma.
The affected BIOCELL textured breast implants and tissue connectors have already been recalled by three dozen countries worldwide. The FDA reports that there is now a total of 573 cases of BIA-ALCL worldwide in women who had Allergan BIOCELL textured breast implants, with 33 of these women dying from cancer. The FDA also states that women with Allergan BIOCELL textured breast implants are 6 times more likely to develop BIA-ALCL than with similar breast implants manufactured by other medical device companies in the United States.
Specific BIOCELL Textured Breast Implants and Tissue Connectors Subject to Recall
Allergan’s recall of its BIOCELL textured breast implants and tissue connectors includes the following products:
- Natrelle saline-filled breast implants;
- Natrelle silicone-filled breast implants;
- Natrelle Inspira silicone-filled breast implants; and
- Natrelle 410 Highly Cohesive Anatomically Shaped silicone-filled breast implants;
All unused products will be removed from shelves. Women with any of the above-listed breast implants are instructed to see their doctors if they have any swelling or pain near the breast implant. Women are not instructed to have the breast implants removed if they do not have any symptoms.
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