Regulatory Focus™ > News Articles > 2019 > 7 > Allergan Pulls Textured Breast Implant Following FDA Request

Allergan Pulls Textured Breast Implant Following FDA Request

Posted 24 July 2019 | By Ana Mulero 

Allergan Pulls Textured Breast Implant Following FDA Request

Allergan followed a US Food and Drug Administration (FDA) request to recall its Biocell textured breast implants in response to an increase in breast implant associated-anaplastic large cell lymphoma (BIA-ALCL) cases.
 
FDA’s Center for Devices and Radiological Health (CDRH) is offering routine updates on an analysis of adverse event reports that describe incidences of BIA-ALCL post-implantation. A Wednesday update on the analysis reports a total of 573 unique BIA-ALCL cases, amounting to 116 new unique BIA-ALCL cases from the February-reported total of 457.
 
The 573 cases include 33 patient deaths, meaning the analysis found 24 additional deaths since the February update reported a total of nine.
 
Out of the 573 cases, 481 were reported among patients implanted with Allergan’s Biocell. This includes 12 of 13 deaths that occurred at the time of the BIA-ALCL diagnosis.
 
With Allergan recalling its Biocell saline-filled and silicone-filled textured breast implants and tissue expanders, the products will “no longer be distributed or sold in any market where they are currently available...effective immediately.” Health care providers should not implant such devices in new patients, Allergan said. The company will later provide information on returning unused products.
 
The agency, however, does not recommend health care providers remove or replace the textured breast implants or tissue expanders in previously implanted, asymptomatic patients.
 
Allergan withdrew its supply of the textured breast implants in EU markets in December 2018. The recalls have not affected its smooth breast implants Natrelle and Microcell.
 
“Patient safety is a priority for Allergan,” the firm told Focus. “Patients are advised to speak with their plastic surgeon about the risks and benefits of their implant type should they have any concerns.” FDA provides recommendations and information about the benefit-risk profile across several pages of information.
 
Aside from FDA, other regulators have recently moved to address their concerns. Swissmedic recommended in February that patients use smooth implants rather than textured ones, pointing to a reported need “to prohibit the use of Allergan’s Biocell.” Macro-textured breast implants and polyurethane-coated breast implants were suspended by France’s regulators in April when Health Canada also announced its intent to suspend the sales of Allergan’s Biocell implants.
 
FDA decided against imposing a ban on textured breast implants after a March advisory committee meeting in which panel members called for additional postmarket data. A challenge FDA has faced in its analysis of BIA-ALCL cases relates to a lack of or limitations in postmarket data collection. It touted the potential of the National Evaluation System for health Technology on Wednesday in noting that its medical device reporting system, while valuable, has “limitations, including incomplete, inaccurate, untimely, unverified or biased data in the reports.”
 
FDA

Regulatory Focus newsletters

All the biggest regulatory news and happenings.

Subscribe