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Consent Decree with Mentor Corporation and Mentor Texas, Inc. Regarding the Manufacture of Silicone Gel and Saline Breast Implants

May 5, 1998

1. Why is 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.

2. What effect does Mentor's manufacturing process have on its breast implants?

Without adequately defined and controlled manufacturing processes, specifications, and procedures, Mentor is more likely to manufacture breast implants that are not uniform. Although these implants may be safe and effective, without validated processes the manufacturer cannot assure that the non-uniform products meet the expectation for safe and effective performance.

3. What kinds of problems with the breast implants potentially result from Mentor's manufacturing process? How serious are the problems?

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.

4. Are women who received Mentor's implants at a higher risk of having them rupture?

FDA does not have conclusive information on Mentor's rupture rate or on rupture rates for other breast implants. In order to obtain information on rupture rates in general, FDA initiated a study with the National Cancer Institute to determine the risk of rupture of silicone gel breast implants. The results of this study are anticipated at the end of 1998.

Various rates of rupture have been reported for silicone gel and saline breast implants. A Mayo Clinic study reported that 5.7% of women had implant ruptures within five years of implantation. Other studies that have verified rupture by implant removal and examination have reported a wide range, from 23%- 53%, of ruptured implants spanning from 0-26 years.

5. What should women who have Mentor implants do?

The deficiencies in Mentor's manufacturing process have not been shown to result in a significantly increased risk to women who have received this company's breast implants. A woman with any concerns about her breast implants should consult with her health care provider. For those who have Mentor implants and are not having problems, the risks associated with surgery do not warrant removing the implants.

6. Will this action cause a shortage of breast implants?

FDA does not anticipate a shortage of silicone gel or saline breast implants. The consent decree allows Mentor to continue manufacturing as it corrects the deficiencies in its manufacturing process. Furthermore, another manufacturer is producing silicone gel and saline breast implants.

7. Is it appropriate for Mentor's implants to remain on the market?

The deficiencies in Mentor's manufacturing process have not been shown to result in a significantly increased risk to women who have received this company's breast implants. FDA has entered into a consent decree with Mentor because the agency is aware of inadequate manufacturing processes, specifications, procedures, and record keeping that could potentially result in some products being defective. This consent decree is a judicially enforceable agreement in which the company agrees to correct the problems, obtain independent verification that the problems have been corrected, and most importantly, manufacture in compliance with the Quality System Regulation in the future. FDA will verify this with inspections. With better quality control, Mentor should be able to manufacture breast implants with a higher level of confidence.

8. What are the next steps for Mentor?

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.

9. 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.

10. Where can I get more general information about breast implants?

Additional information can be obtained at FDA's website. A copy of the FDA publication entitled "Breast Implants, An Information Update" is located at http://www.fda.gov/oca/hotopics.htm. You may also call FDA's Office of Consumer Affairs at 1-800-532-4440.

For more information about the Mentor consent decree, see FDA's Talk Paper

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Updated May 5, 1998

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