1. Why is the FDA taking legal action against Mentor Corp. and Mentor Texas, Inc.?

Mentor Corporation, two of its top corporate executives, and its subsidiary, Mentor Texas, have entered into a <consent> <decree> of injunction with FDA. Under the terms of the <consent> <decree>, Mentor will take steps necessary to ensure that its manufacturing process for breast implants is in compliance with FDA’s Quality System Regulation. Mentor makes both silicone gel and saline breast implants at its Irving, Texas plant.

The action FDA has taken against Mentor is in response to inspections by the agency, which determined that Mentor was not manufacturing its breast implants in compliance with the Quality System Regulation, and that corrective measures that Mentor had promised at an earlier date had not been fully implemented.

The Quality System Regulation requires, among other things, that domestic and foreign manufacturers have in place a quality assurance system for the production of medical devices intended for commercial distribution in the United States. The Quality System Regulation is critical in helping to assure that medical devices are consistently high in quality and are safe and effective.

Under the terms of the <consent> <decree>, Mentor may continue to manufacture and distribute breast implants. The deficiencies in Mentor’s manufacturing process have not been demonstrated to result in a significantly increased risk to women who have received breast implants manufactured by that company. However, FDA inspections of Mentor’s manufacturing facility found deficiencies in the quality assurance system that could potentially affect the safety and quality of the breast implants. Deficiencies that FDA discovered include failure by Mentor to validate its manufacturing process and failure to adequately correct and prevent quality problems.

FDA considers validation of the manufacturing process to be an essential component of the quality assurance system in place at a manufacturing facility. Through validation, a manufacturer can assure with a high degree of probability that all manufactured units will meet the desired specifications and will be of uniform high quality. Consistent conformance to specifications is likely to result in fewer complaints and recalls for a product and to decrease the potential risk to consumers.

FDA believes that the <consent> <decree>, which is a judicially enforceable agreement between Mentor and FDA, provides the agency with the necessary assurance that Mentor will correct the deficiencies in its manufacturing process and maintain a state of compliance afterwards. As a result, Mentor should be able to more consistently manufacture high quality breast implants that provide a greater overall assurance of safety to consumers.

FDA found that the implants may have the potential for problems with the exterior shell and also the packaging of the product.

Potential problems with the exterior shell include defects such as bubbles, creases, or the thinness or thickness of the shell, and could result in implants that would be more likely to deflate or rupture. Once Mentor has properly validated its manufacturing processes, there will be a greater degree of assurance of the safety and quality of its breast implants.

Potential problems with packaging of implants can affect the sterility of the implant. Each Mentor implant is delivered in two sealed packages, one inside the other. The outer package is opened first, and the inner package is opened in the operating room during surgery to maintain a sterile product. In the past, Mentor has experienced problems with the outer and inner seals opening at the same time, potentially contaminating the product. The corrective actions Mentor has promised to take in the <consent> <decree> should remedy this situation.

The <consent> <decree> establishes time frames for Mentor to correct the deficiencies in its quality assurance system. To help in the correction process, Mentor has agreed to hire an outside expert to evaluate the deficiencies at Mentor’s breast implant manufacturing facility. The expert will report the status of Mentor’s corrective actions to FDA at each step in the process, and also will conduct comprehensive inspections of the manufacturing facility annually for the next four years to ensure ongoing compliance with the Quality System Regulation.

What incentives does Mentor have to comply with the <consent> <decree>? If Mentor fails to adequately correct the deficiencies or to maintain ongoing compliance, the <consent> <decree> allows FDA to order the company to stop manufacturing or distributing the breast implants, order a recall, or take other corrective action. In addition, Mentor could be subject to an administrative civil penalty in the amount of $10,000 for each day the company violates certain provisions of the <consent> <decree>.

We know from the FDA reports that all of the substandard implants are sent to other countries, including Canada. Reading the above information helps you understand why the Implant Awareness Society says no breast should be implanted until breast implants can be proven to be safe. Today, the FDA and Health Canada have breast implants categorized as Class III devices, which is an unsafe category.