Hot on the heels of the U.S. Food and Drug Administration's (FDA) safety hearing surrounding the potential relationship of certain breast implants to illness and death, the FDA has asked Allergan, a manufacturer of a certain type of textured breast implant, to issue a voluntary recall of their BIOCELL textured breast implant products from the U.S. market due to the risk of anaplastic large cell lymphoma (BIA-ALCL). Allergan will soon be moving forward with a worldwide recall of these specific implants.
The products recalled include: Natrelle macro-textured 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 recall also includes macro-textured tissue expanders used by patients prior to breast augmentation or reconstruction, including Natrelle 133 Plus Tissue Expander and Natrelle 133 Tissue Expander with Suture Tabs.
The count of global cases of BIA-ALCL was updated today, accounting for 573 unique global cases of BIA-ALCL and 33 patient deaths, an increase of 116 new cases and 24 deaths since the agency's last update earlier this year. Of the 573 cases, the FDA reports 481 are attributed to Allergan implants.
La Jolla, CA plastic surgeon Robert Singer, MD stresses that not all textured implants have been recalled, nor have all tissue expanders. "This recall only has to do with Allergan-manufactured implants and tissue expanders that boast larger textures, or that are macro-textured, not any other implants. There are an estimated 20-35 million people with breast implants around the world, and less than 600 documented cases of BIA-ALCL from textured implants." Eugene, OR plastic surgeon Mark Jewell, MD, who is also an advisor for Allergan and Solta, adds, "Allergan also sells the smooth Natrelle Inspira that has never been associated with BIA-ALCL. Allergan is currently developing its MicroCell texture, similar to Sientra and Mentor."
“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 FDA Principal Deputy Commissioner Amy Abernethy, MD, Ph.D.
“The FDA has been diligently monitoring this issue since we first identified the possible association between breast implants and ALCL in 2011 and, at that time, communicated to patients and providers that there is a risk for women with breast implants, more frequently occurring in women with textured implants, for developing this disease. Since that time, we have worked to increase awareness and encourage reporting of all cases to the FDA so that we could continue to monitor this potential safety signal. As this issue and the science have continued to develop, we have been monitoring the reports in databases, including external patient registries, and in scientific literature. Based on new data, our team concluded that action is necessary at this time to protect the public health. 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. If action is needed in the future, we will not hesitate to do what is necessary to protect patients.”
Dr. Singer advises patients with textured implants to see their plastic surgeon, who should be board certified by the American Board of Plastic Surgery, if they have questions or concerns. "Patients who experience the rare fluid accumulation (Seroma) should see their plastic surgeon and have arrangements for the fluid to be sent to the laboratory for analysis. Not every patient with fluid around a breast implant has BIA-ALCL, but testing is necessary."