FDA
TALK PAPER

Food and Drug Administration
U.S. Department of Health and Human Services
Public Health Service 5600 Fishers Lane Rockville, MD 20857
FDA Talk Papers are prepared by the Press Office to guide FDA personnel in responding with consistency and accuracy to questions from the public on subjects of current interest. Talk Papers are subject to change as more information becomes available. 
T98-24                        Sharon Snider:      301-827-6242
May 5, 1998                   
                              Consumer Inquires:  800-532-4440

MENTOR AGREES TO COMPLY WITH FDA REQUIREMENTS FOR BREAST IMPLANT MANUFACTURING

The Food and Drug Administration today announced that Mentor Corporation has agreed to bring its manufacturing process for breast implants into full compliance with FDA requirements to assure the safety and quality of finished products. Mentor makes both silicone gel and saline breast implants at its Irving, Texas plant.

Mentor, along with 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, which is headquartered in Santa Barbara, Calif., will take steps necessary to ensure that its manufacturing process for breast implants is in compliance with FDA's quality system regulation.

The quality system regulation requires, among other things, that U.S. and foreign manufacturers have in place a quality assurance system for the production of medical devices intended to be commercially distributed in the United States. The quality system regulation is critical in helping assure that medical devices are consistently high in quality and are safe and effective.

The deficiencies in Mentor's manufacturing process have not been shown to result in a significantly increased risk to women who have these breast implants. However, FDA inspections of Mentor's manufacturing facility found deficiencies in the plant's quality assurance system that could potentially affect the safety and quality of the breast implants.

Deficiencies discovered by FDA 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 at a manufacturing facility. Through validation, a manufacturer can assure that there is a high probability that all manufactured units will meet specifications and have uniform high quality. Consistent conformance to specifications is likely to result in fewer complaints and recalls for a product and is expected to decrease the potential risk to consumers.

The consent decree establishes time frames for Mentor to correct the deficiencies in its quality assurance system. Because the deficiencies have not been shown to result in a significantly increased risk to women, FDA is allowing Mentor to continue distributing its products while the company corrects the deficiencies.

To help in this process, Mentor has agreed to hire an outside expert to evaluate the deficiencies. 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.

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.

Finally, Mentor has agreed to reimburse FDA for the costs of any further action, such as inspections, examinations, or analytical or review work, necessary for FDA to evaluate the company's compliance with the consent decree.

Although FDA does not believe that Mentor breast implants are likely to be defective, women who have these implants, or are considering getting them, should consult their physician if they are concerned about possible problems. For those who have Mentor implants and are not having problems, the risks associated with surgery do not warrant implant removal.

For more information about the Mentor consent decree, see FDA's Questions and Answers.

For more information about breast implants, see FDA's Consumer Information Package.

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