The FDA issued two warning letters to breast implant manufacturers this week, including Allergan for failing to complete postmarket safety studies documenting the risks of two implant models the company took off the worldwide market last year.
The letter comes one week after AbbVie finally closed its massive, $63 billion acquisition of Allergan and while its aesthetics business faces new challenges and concerns as providers close up shop in the face of the COVID-19 pandemic.
Last July, Allergan issued a global recall of its textured breast implants, including its Natrelle saline- and silicone-filled breast implants and tissue expanders, months after the FDA disclosed spikes in the number of cases of a specific cancer that develops in the scar tissue surrounding an implant—known as breast implant-associated anaplastic large cell lymphoma, or BIA-ALCL.
The agency’s warning letter this week centers on Allergan’s long-term safety studies of its Natrelle gel-filled implants and Natrelle 410 anatomically shaped implants, which would track the incidence rate of these cancers among other health issues.
After its implants were first approved by the FDA, Allergan was required to conduct a large, 10-year study of nearly 60,000 participants with gel- and saline-filled implants. About nine years later, in 2015, the agency approved a redesigned trial protocol that lowered the enrollment target to 2,775.
The FDA said the studies continued to show poor recruitment and follow-up rates and did not collect adequate safety data at the four-year mark, including rates of local implant complications. The agency gave Allergan 15 days to respond with a correction plan.
The letter echoes similar warnings issued last year to two other breast implant manufacturers in the middle of the FDA’s cancer safety probe—Sientra and Johnson & Johnson’s Mentor Worldwide subsidiary—for failing to enroll thousands of women for annual follow-ups over at least a decade.
“The agency has been diligently tracking post-approval studies as part of our ongoing efforts to evaluate, understand and provide updates to the public on breast implant safety and risks,” said Binita Ashar, director of the FDA’s Office of Surgical and Infection Control Devices. “Post-approval studies are especially important to inform our understanding of the long-term potential risks associated with Allergan’s implants, including the models that have since been recalled from the market due to increased risk of breast implant associated anaplastic large cell lymphoma.”
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“The manufacturer’s low recruitment and low follow-up rates for these devices is unacceptable,” Ashar added. “The FDA will continue to hold manufacturers accountable if they fail to fulfill their obligations.”
The FDA also issued a warning letter this week to Ideal Implant, a Dallas-based manufacturer, for inadequate corrective actions following an inspection of its facility earlier this year and for failing to comply with manufacturing practices and adverse event reporting requirements—another method the agency uses to track implant safety issues.
According to the agency, Ideal did not maintain the proper files for processing and responding to complaints received from customers related to its saline-filled breast implants and did not adequately test that its finished products met specifications. In addition, the company did not immediately report implant malfunctions, the FDA said.