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 MIDLAND, Mich., Nov. 2 /PRNewswire/ -- Dow Corning today released the recommendations made to it on Oct. 27 by Judge Griffin Bell and his investigative team from the law firm of King & Spalding. On Jan. 29, 1992, Dow Corning announced that it had retained Judge Bell and his team to investigate Dow Corning's stewardship of its silicone gel-filled mammary implant business. Dow Corning also pledged to publish and abide by Judge Bell's recommendations.
 "The Bell team conducted a lengthy investigation of our breast implant business," said Keith R. McKennon, chairman and chief executive officer of Dow Corning. "I think it is fair to say to women who have our implants that Judge Bell's recommendations do not raise any significant new public health issues relative to the safety of our implants," McKennon said.
 "Judge Bell's recommendations indicate the programs we initiated are on the right track, but there are some things we can do better," McKennon said. "As we stated in January of this year, we are committed to follow the recommendations that Judge Bell developed, and to share those recommendations not only with the FDA but with the general public as well. Today we are meeting that commitment," McKennon stated.
 McKennon noted that Dow Corning's commitment to implement Judge Bell's recommendations was significant because, as stated by Judge Bell, those "Recommendations address Dow Corning's commitment to continue to make available information related to health and safety issues raised by silicone gel breast implants for the benefit of women with implants, their physicians, the Food and Drug Administration ('the FDA') and the public. We believe that these Recommendations when implemented constitute an appropriate response to that commitment."
 McKennon went on to stress that the Bell team had access to all Dow Corning documents except those specifically covered by attorney/client privilege or work product privilege. The Bell team selected more than 300,000 documents, totaling more than 1 million pages of material. In addition, the Bell team had complete access to Dow Corning employees and retirees and also interviewed a number of other experts and individuals not associated with Dow Corning.
 In a letter that the company is making public today, Judge Bell's team made nine recommendations to Dow Corning, all of which the company supports and intends to act upon within the next 30 days:
 Recommendation No. 1: "During the course of the investigation, King & Spalding obtained from Dow Corning approximately 300,000 documents ('the Dow Corning documents') concerning breast implants, including documents relating to complaints, FDA communications, MDR filings, lot histories, product development, saline inflatable (Varifil) implants, studies, tests, the ASTM standard for breast implants, and a variety of other matters. King & Spalding was given free access to review and select the foregoing materials, with the understanding that any materials deemed to be protected by the attorney/client privilege or work product doctrine were to be returned to Dow Corning. Dow Corning should make the non-privileged Dow Corning documents available to the FDA and should also include the same as a source of documents for potential production in the pending multi-district proceedings."
 Dow Corning intends to supply these documents without restriction and within 30 days to the FDA. The company will also make them available for production as recommended by Judge Bell. Many of these 300,000 documents, which amount to more than 1 million pages, have already been released to the FDA and the general public.
 "We believe the release of this information to the FDA and for production in the Multi-District Litigation Proceedings is consistent with our continuing commitment to provide women with our implants all relevant information concerning the safety and health aspects of silicone breast implants," McKennon said.
 "Because we believe the documents collected by the Bell team raise no significant concerns about the safety of breast implants, these documents should add further evidence to our long-held conclusion that our silicone breast implants met an important medical need and do not pose an unreasonable risk," McKennon added.
 Recommendation No. 2: "Dow Corning should provide to the FDA and the presiding judge in the pending multi-district litigation a list of the names of all witnesses interviewed by King & Spalding during the course of the investigation."
 "In conducting the investigation, the King & Spalding team had access to Dow Corning employees and retirees, and also interviewed a number of other experts and individuals not associated with Dow Corning," McKennon said. "In accordance with this recommendation, we will provide the FDA and the presiding judge with the names of those individuals interviewed by the Bell team," McKennon said.
 Recommendation No. 3: "Dow Corning should continue to review complaints received to assure that Dow Corning reports all events that are required to be reported under the FDA's current interpretation of the MDR regulations."
 The company said it has reviewed all such complaints received since the MDR system was instituted in 1984, including those alleged in current lawsuits and has extensively reported them to the FDA. Dow Corning is currently reviewing its files prior to 1984 and will promptly report on those complaints consistent with the 1992 FDA reporting guidelines.
 Recommendation No. 4: "Dow Corning should retain an independent expert to review its production and recordkeeping practices as well as its program for internal audits of manufacturing practices. The objective of such review would be to assure Dow Corning's compliance with Good Manufacturing Practices and regulatory requirements applicable to the manufacture of medical devices and medical grade materials currently manufactured by Dow Corning."
 The company said this recommendation relates to Dow Corning's ongoing business activities, because Dow Corning has left the mammary implant business. Dow Corning said it has already initiated a complete review and audit of its production and recordkeeping practices and its internal control procedures for medical materials and products. The company said that adding this outside expertise is a prudent step and that it will promptly hire an expert to aid in that process.
 Recommendation No. 5: "To insure that the FDA's 1992 inspection of Dow Corning's breast implant manufacturing facilities is based on a complete record, Dow Corning should advise the FDA (1) that, in violation of company policy and procedures, an unknown number of breast implant lot history records were altered to include replacement oven charts instead of the actual oven charts; (2) that the replacement of charts was discovered in November 1987 and terminated; and (3) that Dow Corning could not determine which lot histories contain replacement charts with the result that the log of atypical lots reviewed by the FDA in 1992 did not refer to the lots containing replacement charts. With respect to lot histories prior to December 1987, Dow Corning records, including the atypical log, should be annotated to recite the facts set forth above. Dow Corning should also release to the FDA the results of its recent testing indicating that these departures from Dow Corning's policies and procedures did not create a health risk."
 The company said that this matter, which relates to temperature recorders on ovens used in one step of the manufacturing process, was discovered and investigated by Dow Corning in 1987. It involved incidents where altered oven chart records were substituted for actual data, in direct contravention of Dow Corning policy.
 The company said that its review at the time concluded that these alterations were made to avoid what some employees perceived as a bureaucratic mandatory review of records that were incomplete or imperfect. These records may have been rendered incomplete because of such factors as power interruptions and restarts in the process, or when a mechanical recording device ran out of ink. The employees who were involved in these incidents were disciplined and the practice was stopped, the company said.
 "The most important thing to keep in mind in viewing this situation is that at no time did this violation of company policy result in increased risk to the health and safety of women who have our implants," McKennon said.
 "I also want to reassure women with our implants that these events were unrelated to Dow Corning's final inspection of silicone gel-filled mammary implants," McKennon added. "Each finished implant was always individually inspected. There is, to the best of my knowledge no evidence that the oven chart incident created a risk to health and safety, or that it affected the quality and suitability of any products offered for sale by Dow Corning," McKennon said.
 "Nevertheless, acting on this recommendation by the Bell team, we have initiated discussion with the FDA on this matter."
 Recommendation No. 6: "Dow Corning should continue to work with the FDA to determine whether any additional periodic medical monitoring is needed for women who have received breast implants."
 The FDA has already held several meetings on this and related questions, the company said, and it has participated along with other manufacturers and other interested parties. Dow Corning will continue to be involved in these discussions.
 Recommendation No. 7: "Dow Corning should continue its existing Explant Policy of providing financial assistance to Dow Corning breast implant patients when removal of their implants is medically indicated and the patient lacks the financial means to cover the cost of removal."
 "When I became CEO of Dow Corning, I stated that my overriding concern was for the women who have our implants," McKennon said. "Since that time we have established a program that provides financial assistance to women who do not have the means to pay for medically indicated removal of their Dow Corning implants."
 "We continue to take people's word on whether or not they need the financial assistance and do not require them to sign a release from any future legal recourse against us. In addition, we will provide one year's notice in the event that we should decide in the future to discontinue this program," McKennon said.
 Recommendation No. 8: "Dow Corning should continue to find medical and scientific studies undertaken to add to the medical and scientific knowledge concerning silicone gel breast implants. The results of these studies should be published for the benefit of women who have breast implants, physicians and the public."
 Since February, the company said it has already spent or committed to spend more than $7 million for such research and it anticipates funding an additional $10 to $13 million. The company has always been committed to making the results of that research publicly available. That commitment is consistent with actions taken by Dow Corning in July of 1991 when it released to the general public its entire body of safety related research contained in Dow Corning's Pre-Market Approval Application to the FDA, the company said.
 "At the time we announced our withdrawal from the breast implant business we made a commitment to spend $10 million to expand our base of research and initiate numerous new studies that would answer the questions women have about silicone breast implants," McKennon said. "We now expect to spend approximately $20 million -- roughly double our earlier estimates."
 Recommendation No. 9: "We recommend that the Chairman of Dow Corning's Board of Directors (Keith McKennon), the Medical Director (Dr. Myron Harrison), the Health Care Business Technical Director (Dr. Robert LeVier) or the Epidemiologist (Dr. Ralph Cook) communicate directly (preferably in person) with the experts we interviewed and obtain their perspectives and views in their respective fields on the health and safety effects of silicone gel breast implants."
 Dow Corning said it intends to contact these experts promptly and, if they are willing, to learn first-hand their views on these subjects.
 In addition to consulting experts, McKennon said the company is also interested in taking additional steps to support women with Dow Corning implants. "We feel good about the various things we have done to address some of the concerns women have about silicone breast implants," McKennon said. "We started by providing information to women through our Implant Information Center. We have handled more than 100,000 calls since the center began, and the average length of those calls is 20-40 minutes.
 McKennon went on to say that Dow Corning has always been committed to conducting ongoing research in support of all of its products. "While thousands of tests have been conducted on silicones over the 30 years in which we have been making implants, the need for additional research is never-ending," McKennon said. "With advancements in medical technology, scientific measurement and epidemiology, we recognize the need for additional research utilizing new technology and approaches."
 Finally, McKennon cited a recent grant the company made to the American Society of Plastic and Reconstructive Surgeon Nurses (ASPRSN) to provide information to women who have implants or want information about them. Often these nurses are a primary contact for many women who have implants, McKennon said. This unrestricted grant given by Dow Corning will allow this organization to compile and distribute information about silicone breast implants from a variety of third-party sources to women who want this information.
 In final comments, McKennon said in his estimate that while Judge Bell has made recommendations about things that could be done differently, those recommendations neither questioned the good faith of the company nor its employees in their activities regarding silicone gel-filled breast implants, nor did they pose any new concerns for the health and safety of women with Dow Corning implants.
 "We are committed to continue the programs that support women with our implants as long as they prove useful. This includes the Implant Information Center, the Explant Program and ongoing research," McKennon said. "We are also committed to maintain the ongoing dialogue we have established with women, their physicians and the FDA as the results of our research becomes available."
 Dow Corning Corporation, a Michigan-based company, is equally owned by The Dow Chemical Company (NYSE: DOW) and by Corning, Incorporated (NYSE: GLW).
 -0- 11/2/92
 /CONTACT: Ronald G. Actis of Dow Corning, 517-496-6443/
 (DOW GLW) CO: Dow Corning Corporation ST: Michigan IN: MTC HEA SU:

ML-JG -- DE005 -- 1541 11/02/92 11:10 EST
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Date:Nov 2, 1992

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