Fw: The split vote on Silicone Breast Implants

[Guest guest]

I am still sad.....prayer is our only hope now for the FDA to come to its senses and veto this recommendation.

----- Original Message ----- From: Zuckerman

ifriends@...

Sent: Thursday, October 16, 2003 9:09 AM

Subject: The split vote on Silicone Breast Implants

Dear Friends,

It's hard to write this note.

Thanks to all the wonderful women and men who told their stories about their breast implants at the FDA's 2-day meeting this week. The testimony was very strong and we know it really influenced many of the panel members.

Many of you know that our staff worked around the clock and helped edit testimony for some patients who testified and also helped arrange for volunteers to read testimony for women who couldn't come. Beth, , , Nikki, Jill, Cathleen, Liz, and all worked so hard to help get the message out (I'm not including last names because we don't know who exactly will get this email). The heads of several organizations, authors Anne Kasper and Bruning, and two former HHS officials also provided important testimony-- their first itme testifying before the FDA: National Council of Women's Organizations, Older Women's League, National Organization for Women, Dads and Daughters, Marcy Gross, and Audrey Sheppard. National Women's Health Network and Breast Cancer Action (both of whom have experience with the FDA) also delivered wonderful testimony. The powerful testimony of all of these individuals and groups really helped get the message across that choice isn't a good thing unless you know the choice is safe.

The vote almost went the other way. Most members of the advisory panel were going to vote to reject the application because the company didn't provide any assurances of safety. Inamed panicked and come up with a list of promises to persuade the panel to vote for approval. It was enough to change a few minds, especially since there was a solid vote of the many plastic surgeons on the panel, all of whom voted to approve silicione gel implants. Most of the other doctors and scientists voted against.

Because the vote is split (6 voted against approval), it is not certain what the FDA will decide.

Please don't give up. We especially want to tell the women with implant problems that there are a lot of friends on your side and please don't be too discouraged. And we already have some ideas of how to continue to get these warnings out.

We will put up the testimony on our website. Meanwhile, I have attached mine.

And I'm happy to say that the press was very supportive of the women's stories. Below is the New York TImes article, which is more balanced than usual.

F.D.A. Panel Backs End of Ban of Silicone Breast ImplantsOctober 16, 2003 By GINA KOLATA GAITHERSBURG, Md., Oct. 15 - In a 9-to-6 vote, an advisorypanel to the Food and Drug Administration recommended onWednesday that silicone breast implants be allowed back onthe market after an 11-year hiatus. But, concerned about a dearth of data on how safe theimplants are and how well they hold up over a decade ormore, the panel said its approval was contingent on a listof conditions, like education of surgeons and patients andcontinued monitoring of women who get implants. The implantmaker, the Inamed Corporation, had volunteered most ofthose conditions in seeking the agency's approval. The Food and Drug Administration usually goes along withthe advice of its expert panels, even when the vote isdivided. Kathleen Quinn, a spokeswoman for the agency, saidit would decide in "weeks to months," but there was nospecific time line. The panel's decision worried some who said they were notconvinced the safety of silicone implants had beenestablished. Some expressed concern that the provisions formonitoring women with implants were not enough to make adifference. "This was a triumph of wishful thinking over science," saidDr. Zuckerman of the National Center for Policy andResearch for Women and Families, an educational andadvocacy group. Others said the panel's decision was the right thing to do."There are no serious health risks, and women like them andwant to use them," said Dr. Connell, an emeritusprofessor of obstetrics and gynecology at Emory University.Dr. Connell was the chairwoman of a 1992 F.D.A. panel thatrecommended a moratorium on the sale of implants while datawere gathered on their safety. Dr. Connell is now a seniorcounselor to Citizens Against Lawsuit Abuse, an advocacygroup, but said she had no connection to Inamed. She saidshe was satisfied with the data compiled since 1992. Panel members said they had agonized over their votes.Women can have saline breast implants, but many say theyfeel hard and unnatural and can suddenly deflate. Panel members said they worried about the paucity ofinformation on how likely a silicone implant was to ruptureor what sort of complications could be expected after twoyears or so. Yet the agency generally allows device makersto start selling their products after they complete 2 yearsof a 10-year study. And Inamed had worked with thegovernment to prepare the data the agency requested. "This was unbelievably difficult, much more difficult thanI had ever anticipated," said a panel member, Dr. O. , the director of the Breast Health Center inSeattle and associate professor of surgery at theUniversity of Washington. He voted in favor of approval, hesaid, because "ultimately I believe in the right to chooseand informed consent." One panel member, Dr. A. Dubler, who directs thedivision of bioethics at Montefiore Medical Center in theBronx, changed her mind hours before the vote. "I came back from lunch prepared to vote no," Dr. Dublersaid. But she reversed herself after hearing Inamed's plansto educate women and doctors, to monitor women and tosupply data on the device's safety after it is approved. If the agency follows the committee's advice, siliconebreast implants will have made a remarkable comeback aftera highly public and explosive fall from grace. The devices have been largely unavailable since 1992, whenthe Food and Drug Administration asked manufacturers towithdraw them from the market, citing concerns that data ontheir safety were lacking. In the years that followed,hundreds of thousands of women sued the implant makers,saying the devices caused ailments like autoimmune disease,neurological diseases, chronic fatigue syndrome and cancer."There used to be 10 companies making implants, said Dr. , a panel member who is a plastic surgeon atthe University of Texas M.D. Cancer Center inHouston. "The competition has been destroyed." Inamed said it hoped its studies would satisfy thegovernment that its implants could be sold. The advisorycommittee hearings were held to allow a disinterested panelof experts a chance to hear the company and those who hadstrong opinions about implants. Over a two-day period, starting at 8 a.m. on Tuesday andadjourning after midnight, then starting again at 7:30 a.m.Wednesday, the panel heard presentations of data from theagency's staff and from Inamed and heard often emotionalstatements from more than 100 people, with widely divergentviews. Many women who had had implants told the panel they weresilicone victims, with serious medical problems. Otherssaid they were delighted with their implants, includingcancer patients who pleaded with the panel to let womenhave the opportunity to choose the silicone version forreconstructive surgery. The panel also heard Inamed's assertion that it hadimproved the device in the last decade, making it with athicker shell and filling it with a more cohesive gel. Thecompany said it had seen a rupture rate of about 1 percenta year. "Although that is higher than I would like, it is not thedoomsday scenario that many people would have you believe,"said Dr. Spear, a consultant to Inamed and a plasticsurgeon at town University. He said that the most common device-related complicationthat led to additional operations was contracture, theformation of painful scar tissue that forms over animplant. Dr. Spear said that over two years, 7 percent ofwomen who had implants for augmentation and about 15percent of women who had them for breast reconstructionneeded more surgery for this reason. But, he said,government-approved saline-filled breast implants alsoelicit contracture, and at the same rate. With any plastic surgery, Dr. Spear said, it is common forpatients to have operations to improve or repair theoriginal procedures. For example, he said, 20 percent ofpatients who had nose reconstruction had additionalsurgery. "Some members expressed concern that 20 percent ofaugmentation patients and 45 percent of reconstructionpatients have re-operations," Dr. Spear said. "Re-operationand revision is part of what distinguishes plastic surgeryfrom other fields of surgery." Dr. Dubler said she still worried about the safety ofimplants over periods of longer than two years. "So I'm faced with a problem," Dr. Dubler said before shemade up her mind to vote yes. "To approve something whichdoesn't have the data to support its safety seems to me tobe irresponsible, but not to expand access seems mean." Dr. suggested that the panel's problem reflected adeeper issue. Safety, he said, is a ratio of benefit torisk, and when it comes to implants, few agree on benefits.Some who testified at the meeting felt so strongly thatbreast implants were unnecessary, and even immoral, thatnot even a perfect safety record would persuade them thatthey should be sold. Others saw such an enormous benefitthat they were willing to accept substantial risk. The risks of the device, in contrast, "are pretty clear,"Dr. said. There is a short-term risk, primarily ofrupture or contracture. As for long-term risks, of diseaseslike cancer, chronic fatigue, lupus, arthritis andneurological disorders, they have not shown up in largeepidemiological studies, he said. "What we have to avoid is getting into the business ofdeciding for people what the benefit is," Dr. said."The person who wants the surgery has to go through therisk-benefit exercise in their own mind. A large amount oflatitude has to be given to people to decide forthemselves." http://www.nytimes.com/2003/10/16/health/16IMPL.html?ex=1067272415 & ei=1 & en=8c21f46b7e0b95d0---------------------------------Get Home Delivery of The New York Times Newspaper. Imaginereading The New York Times any time & anywhere you like!Leisurely catch up on events & expand your horizons. Enjoynow for 50% off Home Delivery! 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