By Hadassa Kalatizadeh
The Food and Drug Administration in the U.S. is recalling textured breast implants and tissue expanders for greatly increasing the risk to a rare cancer. The implants, made by pharmaceutical giant Allergan, have already been linked to the cancer in Europe and banned towards the end of 2018. As reported by the NY Times, the announcement made on Wednesday July 24th is based on the growing number of instances and deaths from the implant-associated cancer. Allergan has now voluntarily recalled the Biocell implants globally. “Allergan is taking this action as a precaution following notification of recently updated global safety information concerning the uncommon incidence of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) provided by the U.S. Food and Drug Administration (FDA),” Allergan said in a press announcement.
Around the world, there have been a total of 573 cases reported of the unusual cancer, named breast implant-associated anaplastic large cell lymphoma, or BIA-ALCL. Out of those, 481 of the cases were clearly attributed to the Allergan Biocell implants. There have also been 33 associated known deaths. The FDA also concluded with certainty that 13 of the 33 victims of the cancer had the now-recalled textured implant, and 12 of the victim’s implants were made by Allergan.
While this kind of textured breast implant represents only less than five percent of all the breast implants sold in the United States, they are more commonly used in other countries. “It’s our estimation that hundreds of thousands of women have these implants,” said Dr. Binita Ashar, director of the office of surgical and infection control devices at the FDA. She went on to add that the FDA will gather more accurate figures in the upcoming weeks.
As per CNN, the recalled textured breast implants include: 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. The names of the tissue expanders recalled include: Natrelle 133 Plus Tissue Expander and Natrelle 133 Tissue Expander with Suture Tabs. People who have had these types of implants need not immediately remove them, but rather should learn about the symptoms and monitor the affected area regularly for unexpected changes. Main symptoms of BIA-ALCL include swelling or pain in the area of the implant, which may even begin years after the placement of the implant. Also women should also be aware that breast implants in general are not always a lifelong product, and up to 20 percent of women with implants of all varieties need to have them removed due to complications within 8 to 10 years.
“Although the overall incidence of BIA-ALCL appears to be relatively low, once the evidence indicated that a specific manufacturer’s product appeared to be directly linked to significant patient harm, including death, the FDA took action to alert the firm to new evidence indicating a recall is warranted to protect women’s health,” said Dr. Amy Abernethy, the FDA’s principal deputy commissioner of food and drugs. “We will continue to monitor the incidence of BIA-ALCL across other textured and smooth breast implants and tissue expanders as well as other devices intended for use in the breast,” she said. “If action is needed in the future, we will not hesitate to do what is necessary to protect patients.”
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