By Allison Prang
Allergan and Ideal Implant Inc., manufacturers of breast implants, were issued warning letters from the U.S. Food and Drug Administration, the regulator said, for not complying with regulations.
The FDA said Allergan, which is now owned by AbbVie, didn't do post-approval studies to evaluate the risks and safety on a long-term basis for two implant models. The implants were recalled last year, the FDA said.
The regulator said its letter to the company mentioned "several serious deficiencies in the manufacturer's post-approval study" for two types of implants: its Round Responsive implants and Style 410 implants.
Ideal Implant didn't meet "good manufacturing practice requirements and adverse event reporting requirements," the FDA said.
The FDA's letter to Ideal Implant pointed out that the company didn't keep "proper files for device complaints," and also didn't have "appropriate procedures for implementing corrective and preventive actions." The regulator said the company didn't "maintain adequate criteria for testing finished devices."
The regulator asked both companies to respond within 15 workdays of being issued the its letters.
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