Fw: Mentor Agrees to Comply with FDA Requirements for Breast Implant Manufacturing (FDA Talk Paper 98-24, May 5, 1998) (2 articles)

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Subject: Mentor Agrees to Comply with FDA Requirements for Breast Implant

Manufacturing (FDA Talk Paper 98-24, May 5, 1998) (2 articles)

> http://www.fda.gov/cdrh/breastimplants/

>

> http://www.fda.gov/bbs/topics/ANSWERS/ANS00867.html

>

> Mentor Agrees to Comply with FDA Requirements for Breast Implant

> Manufacturing (FDA Talk Paper 98-24, May 5, 1998)

>

> 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 Broadcast Media: 301-827-3434

> 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.

>

> ~~~~~~~

> http://www.fda.gov/cdrh/breast/mentor.html

> Questions and Answers about May 5, 1998, Consent Decree concerning Breast

> Implants made by Mentor Corp.

>

> 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.

>

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