The FDA has issued two warning letters to breast implant manufacturers—including Sientra and a Johnson & Johnson subsidiary—in the middle of newly galvanized agency probes into the long-term safety and biocompatibility of silicone-based implants.
The March 18 letters chided the companies for failing to complete postmarket evaluations of their products, which mandated enrolling thousands of women for annual follow-ups over at least a decade.
They were required to collect data on any signs of cancer, rheumatologic and neurologic symptoms, or connective tissue diseases, as well as any complications from the implant itself, such as infections or ruptures.
The warnings come just days after the FDA announced it has begun a scientific re-evaluation of certain materials used in long-term, implanted devices, including silicone breast implants, after a subset of patients reported getting sick years after their procedures.
In the letter to J&J’s Mentor Worldwide unit, the FDA said the companies had failed to meet enrollment milestones for recipients of its MemoryShape breast implant, which was approved in June 2013.
As of mid-December of last year, only 102 participants had been enrolled. Mentor did, however, enroll over 1,900 recipients of a separate product in the postmarket study, MemoryGel, which the FDA approved in November 2006.
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Sientra, meanwhile, was cited for declining study retention rates after three years of follow-up, disclosed to the agency in a study update report earlier this month. The company’s FDA-approved protocol had mandated targets for follow-up rates at years 2, 5, 8 and 10 of the study. The FDA had previously labeled the study’s progress as inadequate last May, following poor follow-up dates after two years.
In a note to investors, Wells Fargo analysts said that Sientra believes the agency wants to see a patient follow-up rate of 65% after 10 years in the study, which has enrolled about 5,000 participants. Currently, the company stands at 61% at year three, but it would need to be closer to 80% to hit the FDA’s future targets, they wrote.
The three companies were all given 15 working days to provide plans to address their respective issues, and a timetable of corrections.
While most patients have no adverse reactions to implants of metal, plastic or silicone, the agency said some patients that may develop local or general inflammatory responses years later, and potentially long after a clinical study has concluded.
The FDA called for new tests to be developed to identify at-risk patients—and pledged to update its reviews of product materials, as well as work with companies to recall and correct issues after devices are on the market.
In February, the FDA detailed a spike it observed in reports of a rare type of lymphoma associated with silicone breast implants, and provided a breakdown of the raw adverse event data it has received regarding the type of breast implant, reasons for use and characteristics such as surface texture.
In addition, the agency is hosting a two-day advisory panel meeting next week on its ongoing assessment of breast implants and their long-term health effects.
In its investor note, the Wells Fargo analysts labeled the warning letters as agency posturing ahead of the committee meeting, but said they believe the FDA is likely to require additional monitoring in the future.