DALLAS (CBSDFW.COM/AP) – The U.S. Food and Drug Administration issued a warning letter to Dallas-based Ideal Implant Incorporated for failure to comply with current good manufacturing practice requirements and adverse event reporting requirements following an inspection conducted earlier this year.
The letter revealed the Ideal saline-filled breast implants were adulterated due to a failure to maintain proper files for device complaints the manufacturer received from customers, failure to establish and maintain appropriate procedures for implementing corrective and preventive actions and failure to establish and maintain adequate criteria for testing finished devices.
“Quality system inspections are a way for the FDA to determine if a manufacturer’s activities and procedures, conducted during and after the manufacturing of a device, comply with applicable regulations. When these regulations are followed, it results in safer products for patients,” said Binita Ashar, M.D., director of the Office of Surgical and Infection Control Devices in the Center for Devices and Radiological Health.
The FDA’s inspection also revealed the products were misbranded because the firm failed to provide timely reports of device malfunctions to the FDA that could result in death or serious injury.
“To protect patients, the company should now take additional action to make sure these issues are properly addressed. Addressing quality system and medical device reporting violations helps ensure patient safety, which is our top priority,” said Dr. Ashar.
The FDA requested a response from Ideal Implant Inc. within 15 working days of issuance of the warning letter with details about how the company will correct the violations. Failure to address the violations identified within the Warning Letter could result in enforcement action, such as seizure, injunction and civil money penalties.
The agency also issued a warning letter to another breast implant manufacturer — Allergan of Irvine, California.
It was sent for failure to comply with requirements-under two separate premarket approval orders-to conduct post-approval studies to assess the long-term safety and risks of two models of breast implants, both of which were voluntarily recalled from the market last year.