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Page 2 • • • LEVEL 1- 1 OF 4 STORIES Copyright 1994 National Public Radio NPR SHOW: Morning Edition (NPR 6:00 am ET) June 16, 1994 Transcript # 1369-2 TYPE: Package SECTION: News; Domestic LENGTH: 901 words HEADLINE: New Study Says Breast Implants are Not a Health Risk GUESTS: ELIZABETH CONNELL, Physician, Emory University; MICHAEL HUGO, Lawyer Representing Women Suing Over Breast Implants; GEORGE ANNIS, Attorney, Boston University's Medical School BYLINE: CHRISTOPHER JOYCE HIGHLIGHT: Just one day before women suing breast implant makers must decide whether or not to accept a settlement, the "New England Journal of Medicine" issued a report stating breast implants do not pose a health risk. BODY: BOB EDWARDS, Host: A study reported in today's New England Journal of Medicine raises questions about the dangers of silicone breast implants. The study finds no link between the implants and many of the diseases commonly associated with the device. The report comes at a crucial time. Tomorrow, women who have sued implant makers must choose whether to stay in court or accept a cash settlement. NPR's Christopher Joyce examines how this study could affect their decision and breast implant regulations. CHRISTOPHER JOYCE, Reporter: Silicone breast implants were once considered a breakthrough for women who had lost a breast to surgery or who wanted to change the way they looked. But, then women began to complain that the implants were making them seriously ill. Lawsuits against the manufacturers followed, the Food and Drug Administration stepped in and, in 1992, decided that women could only get silicone implants as part of a study, to see if they were safe. Physician Elizabeth Connell, of Emory University, headed a committee that advised the FDA on implants. There was very little research on silicone implants and disease at the time. ELIZABETH CONNELL, Physician, Emory University: We did not have really any good evidence. We had large amounts of anecdotal material, but, the bottom line was that there was no clear evidence of an association. ~.EXIS~ NEXISp= ~= LEXIS~~ NEX1S ==_ LEXIS ~ NEX15~=== Servrces of Mead Data Central, tnc.

i Morning Edition (NPR), June 16, 1994 • • • Page 3 JOYCE: The FDA decided to restrict access to implants anyway because they couldn't be sure there wasn't a danger to women. Today's study by scientists at the Mayo Clinic is the first large-scale examination of implants and connective tissue disease, such as arthritis, rheumatism, and various skin disorders. It found no link between implants and these diseases in more than 700 women studied. Connell says the Mayo Clinic's findings would have been helpful back in 1992, but, she says more still needs to be done. Dr. CONNELL: You know, it takes more than one swallow to make a summer, and I would view this as a first step toward the accumulation of a number of studies looking at these issues, perhaps with slightly different design- different subjects. I don't think this in itself is gonna make a quantum change in the FDA position. JOYCE: But, the study could influence thousands of women suing implant manufacturers. Earlier this year, Dow Corning Company, and other silicone implant manufacturers, said they'd rather pay than fight, and set up a $4.2 billion fund to pay off plaintiffs. Women can choose to get money now or continue to sue. MICHAEL HUGO, Lawyer Representing Women Suing Over Breast Implants: At this time, before tomorrow's deadline for opting out of the settlement, I think that there are approximately 20,000 cases pending. JOYCE: That's Michael Hugo [sp], a lawyer who represents some of the estimated 20,000 women whose lawsuits over silicone implants are still pending. He's worried about how women will respond to the study. [interviewing] Do you think that the findings in this scientific paper will encourage women to go into the settlement instead of fight it in the courts? Mr. HUGO: If they're not informed as to what the findings truly are, yes. JOYCE: Hugo says the study isn't as strong as it first may appear. He says it was based on limited information and didn't follow women's health for long enough. The New England Journal defends the study, noting that it was examined by three outside experts before being published, and is the best study to examine safety of silicone implants to date. And a researcher who spent years studying implants and skin disease says the Mayo Clinic's work confirms her own findings - no cause and effect from implants. But, the fate of silicone implants is being played out in more courtrooms than in laboratories, and the study has flaws that will limit its usefulness in ~ court, says George Annis [sp], a lawyer who specializes in health issues at p Boston University's Medical School. Fp, ~ GEORGE ANNIS, Attorney, Boston University's Medical School: Number one, the C~ methodology of the study itself is limited. W C7) JOYCE: That's because it's retroactive. It simply looks back at women's medical 00 histories. A kind of study scientists view as valid, but weak. Then there's _J the fact that a plastic surgeon's group helped fund the study. VT ~ NEXIS~= =~ LEXIS~• NEX1S~= ~= LEXIS~ NEXIS@ =~_ ~.EX1S Services of Mead Data Central, )nc.

V ti !• • Morning Edition (NPR), June 16, 1994 Page 4 Mr. ANNIS: Number two, the fact that it was funded by the plastic surgeons is, of course, going to call its validity into question. JOYCE: Not because scientists are easily bought necessarily, but, because it casts doubt in the minds of judges and juries. Mr. ANNIS: And, third, the legal system doesn't see any one study as definitive, just another thing to argue about. JOYCE: Meanwhile, more studies are underway, and the FDA will continue to evaluate evidence about the safety of silicone implants, and whether its decision to limit their availability was correct. In Washington, I'm Christopher Joyce. [music] EDWARDS: The time is 19 minutes past the hour. ['All Things Considered' promo] [music] [news headlines] [music] The preceding text has been professionally transcribed. However, although the text has been checked against an audio track, in order to meet rigid distribution and transmission deadlines, it may not have been proofread against tape. LANGUAGE: ENGLISH LOAD-DATE-MDC: June 16, 1994 ~EXIS~ NEXIS == TM LEXIS~ NEXIS =~ _ LEXIS" NEXIS =~_ Senrrces ot Mead Data CentraJ, Jnc.