KING & SPALDING

191 PEACHTREE STREET

ATLANTA. GEORGIA

30303-1760

404/572-4800

TELEX: 34-2917 KINGSPAID, ATL

TELECOPIER: 404/572-3100

1730 PENNSYLVANIA AVENUE. NW. 745 FIFTH AVENUE

WASHINGTON DC 20008 NEW YORK NY 20151

TELEPHONE 202/737/0500 October 27, 1992 TELEPHONE 212/758/8700

TELECOPIER 202627-3737 TELECOPIER: 222/593/3873 

Members

Dow Corning Board of Directors

2200 West Salzburg Road

Midland, Michigan 48686-0994

Re: Dow Corning Silicone Gel Breast Implant Investigation

Gentlemen:

In January 1992, Dow Corning Corporation retained Griffin B. Bell and King & Spalding to conduct an investigation of Dow Corning's development, production and marketing of silicone gel breast implants. We were asked to develop recommendations for Dow Corning based on the investigation. This document sets forth the recommendations that we now make to Dow Corning. These 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. Since Dow Corning permanently withdrew from the -production and marketing of breast implants during the course of the investigation, these recommendations do not embrace business management. The Recommendations are strictly for the benefit of Dow Corning, and are not offered in any way to induce any person or entity to take or to forego any action with respect to Dow Corning.

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

October 27, 1992 page 2

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.

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.

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.

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.

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.

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.

Page 3

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.

Recommendation No. 8

Dow Corning should continue to fund 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.

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.

Our engagement is concluded. We have enjoyed working with you.

Sincerely,

(signed Griffin Bell by RAS)

King & Spalding

By: Griffin B. Bell

/laa

NOTE: A telecopied version of this letter was signed by Griffin B. Bell and delivered to Dow Corning in Midland, Michigan on October 27, 1992. This hard copy version is being sent to Dow Corning on October 29, 1992, and it was signed for Griffin B. Bell by Richard A. Schneider.