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FDA Requests Manufacturer Recall of Some Textured Breast Implants


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On July 24, the U.S. Food and Drug Administration (FDA) requested that Allergan, the manufacturer of a specific type of textured breast implant, recall specific models of its textured implants from the U.S. market due to the risk of breast implant–associated anaplastic large cell lymphoma (ALCL). Following the agency’s request, Allergan has notified the FDA that it is moving forward with a worldwide recall of its BIOCELL textured breast implant products, including 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 recall also includes 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 recall helps ensure that unused products are removed from suppliers and doctors’ offices.

The agency also issued a safety communication for patients with breast implants, patients considering breast implants, and health-care professionals outlining the known risks and what steps patients should consider when monitoring for symptoms of breast implant–associated ALCL, including swelling and pain in their breasts.

“Although the overall incidence of [breast implant–associated] 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, PhD. “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 [breast implant–associated] ALCL across other textured and smooth breast implants and tissue expanders as well as other devices intended for use in the breast.”

More Information Available From the FDA

In a table updated on the agency’s breast implant–associated ALCL webpage,1 the FDA provides the new total of 573 unique cases globally of breast implant–associated ALCL and 33 patient deaths, which reflect a significant increase in known cases of breast implant–associated ALCL since the agency’s last update earlier this year2—an increase of 116 new unique cases and 24 deaths. Specifically, of the 573 unique cases of breast implant–associated ALCL, 481 are attributed to Allergan implants.


We will continue to monitor the incidence of [breast implant–associated] ALCL across other textured and smooth breast implants and tissue expanders as well as other devices intended for use in the breast.
— Amy Abernethy, MD, PhD

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Of the 33 patient deaths the FDA reported as of July 24, 12 of the 13 patients for which the manufacturer of the implant is known are confirmed to have an Allergan breast implant at the time of their diagnosis of breast implant–associated ALCL. These cases include new data reported to the agency since the public advisory committee meeting in March. Based on the currently available information, including the newly submitted data, analysis demonstrates that the risk of breast implant–associated ALCL with Allergan BIOCELL textured implants is approximately six times the risk of breast implant–associated ALCL with textured implants from other manufacturers marketing in the United States.

The table on the FDA’s website summarizes the cases, along with a breakdown of important information such as breast implant surface texture, patient’s age at diagnosis, time from last implant to diagnosis, and other details to give patients and health-care professionals the most complete information possible about the known factors impacting these unique cases and deaths. The FDA is continuing to evaluate these additional case reports and will make this information available on its database of adverse event reports in the near future.

More on Textured Breast Implants

Textured breast implants overall are less commonly used in the United States than in other countries, and specifically macrotextured implants (the type of textured implant that Allergan manufactures) represent less than 5% of all breast implants sold in the United States. The action by the FDA is similar to other actions initiated in France, Canada, and Australia, where the use of textured implants is much higher—sometimes as high as 80% of the market share. In these countries, actions to prompt the recall or removal of certain textured breast implants (including certain breast implants sold by Allergan) from the market have also been initiated or taken.

Next Steps

In addition to the voluntary recall, the agency is considering recommendations for changes to the labeling of breast implants, which could include a boxed warning and a patient decision checklist to help women consider the benefits and risks of breast implants.

The FDA will continue to focus on gathering available evidence to help inform future regulatory actions and assure that women and health-care professionals are informed of the risk of breast implant–associated ALCL as they consider breast implants. To this end, the agency has requested that all breast implant manufacturers provide quarterly trending analyses of adverse events (including breast implant–associated ALCL) and require reporting individual events in the adverse event database for devices and in existing registries. The FDA will continue to analyze all available information regarding risks associated with breast implants, routinely update the breast implant–associated ALCL analysis published on its website, and take additional actions when and where necessary. 

REFERENCES

1. U.S. Food and Drug Administration: Medical device reports of breast implant–associated anaplastic large cell lymphoma. Available at www.fda.gov/medical-devices/breast-implants/medical-device-reports-breast-implant-associated-anaplastic-large-cell-lymphoma. Accessed July 24, 2019.

2. U.S. Food and Drug Administration: Statement from Binita Ashar, MD, of the FDA’s center for devices and radiological health on agency’s continuing efforts to educate patients on known risk of lymphoma from breast implants. Available at www.fda.gov/news-events/press-announcements/statement-binita-ashar-md-fdas-center-devices-and-radiological-health-agencys-continuing-efforts. Accessed July 24, 2019.


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