Fw: Update on saline implants

[Guest guest]

FYI! From Zuckerman

MM

Martha Murdock, DirectorNational Silicone Implant Foundation | Dallas Headquarters"Supporting Survivors of Medical Implant Devices"4416 Willow LaneDallas, TX 75244-7537

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

Martha Murdock

Sent: Wednesday, September 04, 2002 11:23 PM

Subject: Update on saline implants

Dear Friends,

This new article is going up on our website (www.breastimplantinfo.org), in the Recent Research section.

We are in the process of revamping our website, so I hope you'll visit and send us your suggestions. We'd like to make the website more useful to women who are considering implants, especially the growing number of young women who may not be as well informed as they should be.

We'd love to hear from you.

Best wishes,

Zuckerman, Ph.D.National Center for Policy Research (CPR) for Women & Families

July 2002 Update On Saline Breast Implants: New 5-Year Studies Available

By Zuckerman, Ph. D.

Saline breast implants were approved by the FDA in May 2000, even though members of their Advisory Panel expressed shock about the high rate of hardness, pain, additional surgery, and other local complications. The FDA required the manufacturers to keep studying their implants, and the latest results were made public at an FDA meeting on July 9, 2002. After seeing the studies, the FDA’s Advisory Panel again expressed dismay because so many women experienced serious complications, and because safety data are still lacking.

The meeting was requested by the FDA Advisory panel that had recommended FDA approval of saline implants in 2000, under the condition that the companies, Mentor and Inamed (formerly McGhan), conduct long-term safety studies. Both companies provided at least three years of data on complications in 2000 and five years of data on complications at the July 2002 meeting. However, of the more than 1200 women in the Mentor study of breast augmentation patients, only 60 (5 percent!) were analyzed at the five-year follow-up. Physicians, researchers, and the ethicist and consumer representative on the Advisory Panel said an informed choice was impossible for Mentor patients because of the low response rate.

Study Problems

A study of 60 augmentation patients is not large enough to provide useful safety data on breast implants, but the greater problem is that when 95% of the women in a study drop out, nobody knows if those who remain in the study are different than those who don’t. The concern is that women who dropped out of the study may have very different medical problems than those who participated -- whether they are healthier or more ill.

Although Mentor subsequently obtained some data for about half of the augmentation patients who were supposed to be in their study, one member of the Advisory panel criticized Mentor for its "mind boggling poor results." I think that was very kind. As a former faculty member, I can honestly say that if an undergraduate student presented these data to me, I would have flunked them.

Approximately half the breast cancer reconstruction patients in the Mentor study were analyzed after five years. Although better than the breast augmentation study, this is still considered a very poor response rate.

Health Problems, Cosmetic Problems, More Surgery, and Other Complications

The study by Inamed (formerly called McGhan) was better designed, but many of the women in the study had serious complications or needed additional surgery. For example, during the first five years of having implants, 45 percent of breast cancer reconstruction patients required additional unplanned surgery, 28 percent had their implants removed, 39 percent had breasts that did not match in appearance, 36 percent had capsular contracture (hardness), 27 percent had implants that were visible or could be felt, and 25 percent had implants that created a wrinkling appearance, 18 percent had implants that had moved to the wrong location, 18 percent had breast pain, and 8 percent had implants that leaked or deflated. The rates of 10 other complications such as infections, skin necrosis (skin death) and implants extruding through the skin ranged from 3 percent to 7 percent each.

There are other reasons to be concerned about the safety of breast implants. Four members of Congress recently asked the FDA about a criminal investigation of Mentor. The FDA says they cannot discuss any ongoing criminal investigations publicly. Two of the Congressmen also asked the FDA to provide the Advisory Board with recent studies conducted by the National Cancer Institute. One of these studies showed an increased risk of cancer for women with saline or silicone implants compared to other women, and the other showed an increase risk of death from brain cancer or lung diseases among women with saline or silicone implants, compared to other plastic surgery patients. (DANIELLE - PLEASE provide link here TO OUR PRESS RELEASE ON THIS TOPIC FROM LAST YEAR). Why didn’t the FDA provide the data to their own Advisory Panel, or at least mention the studies, since one of their own scientists helped conduct the research?

What Next?

The bottom line: more than 250,000 women underwent implant surgery last year, more than 200,000 of them to increase the size of their healthy breasts. At the same time, 60,000 women had their implants removed. The Mentor study is too poorly done to be published in a medical journal, but the Inamed study should be published and made widely available so that plastic surgeons and their patients will know that serious complications are very common. Patient advocates hope that the FDA will develop a booklet for plastic surgeons and revise their consumer publications on breast implants to include the Inamed study and the cancer studies.

What happens to women who have had breast augmentation or breast reconstruction for 15 or 20 years? Almost 40 years after silicone breast implants were invented, we still know very little about their long-term safety.

Zuckerman, Ph.D., is president of the National Center for Policy Research (CPR) for Women & Families, a nonprofit research center that provides health information about women, children, and families.

[Guest guest]

I know this already went out to the group, but I just wanted to highlight this very important statement from Dr. Zuckerman. Should this not be a screaming alarm to the medical community?????? Geeze, I cannot believe the cavalier attitude that still exists surrounding implants!!!

"One of these studies showed an increased risk of cancer for women with saline or silicone implants compared to other women, and the other showed an increase risk of death from brain cancer or lung diseases among women with saline or silicone implants, compared to other plastic surgery patients."

Dear Friends,

This new article is going up on our website (www.breastimplantinfo.org), in the Recent Research section.

We are in the process of revamping our website, so I hope you'll visit and send us your suggestions. We'd like to make the website more useful to women who are considering implants, especially the growing number of young women who may not be as well informed as they should be.

We'd love to hear from you.

Best wishes,

Zuckerman, Ph.D.PresidentNational Center for Policy Research (CPR) for Women & Families

July 2002 Update On Saline Breast Implants: New 5-Year Studies Available

By Zuckerman, Ph. D.

Saline breast implants were approved by the FDA in May 2000, even though members of their Advisory Panel expressed shock about the high rate of hardness, pain, additional surgery, and other local complications. The FDA required the manufacturers to keep studying their implants, and the latest results were made public at an FDA meeting on July 9, 2002. After seeing the studies, the FDA’s Advisory Panel again expressed dismay because so many women experienced serious complications, and because safety data are still lacking.

The meeting was requested by the FDA Advisory panel that had recommended FDA approval of saline implants in 2000, under the condition that the companies, Mentor and Inamed (formerly McGhan), conduct long-term safety studies. Both companies provided at least three years of data on complications in 2000 and five years of data on complications at the July 2002 meeting. However, of the more than 1200 women in the Mentor study of breast augmentation patients, only 60 (5 percent!) were analyzed at the five-year follow-up. Physicians, researchers, and the ethicist and consumer representative on the Advisory Panel said an informed choice was impossible for Mentor patients because of the low response rate.

Study Problems

A study of 60 augmentation patients is not large enough to provide useful safety data on breast implants, but the greater problem is that when 95% of the women in a study drop out, nobody knows if those who remain in the study are different than those who don’t. The concern is that women who dropped out of the study may have very different medical problems than those who participated -- whether they are healthier or more ill.

Although Mentor subsequently obtained some data for about half of the augmentation patients who were supposed to be in their study, one member of the Advisory panel criticized Mentor for its "mind boggling poor results." I think that was very kind. As a former faculty member, I can honestly say that if an undergraduate student presented these data to me, I would have flunked them.

Approximately half the breast cancer reconstruction patients in the Mentor study were analyzed after five years. Although better than the breast augmentation study, this is still considered a very poor response rate.

Health Problems, Cosmetic Problems, More Surgery, and Other Complications

The study by Inamed (formerly called McGhan) was better designed, but many of the women in the study had serious complications or needed additional surgery. For example, during the first five years of having implants, 45 percent of breast cancer reconstruction patients required additional unplanned surgery, 28 percent had their implants removed, 39 percent had breasts that did not match in appearance, 36 percent had capsular contracture (hardness), 27 percent had implants that were visible or could be felt, and 25 percent had implants that created a wrinkling appearance, 18 percent had implants that had moved to the wrong location, 18 percent had breast pain, and 8 percent had implants that leaked or deflated. The rates of 10 other complications such as infections, skin necrosis (skin death) and implants extruding through the skin ranged from 3 percent to 7 percent each.

There are other reasons to be concerned about the safety of breast implants. Four members of Congress recently asked the FDA about a criminal investigation of Mentor. The FDA says they cannot discuss any ongoing criminal investigations publicly. Two of the Congressmen also asked the FDA to provide the Advisory Board with recent studies conducted by the National Cancer Institute. One of these studies showed an increased risk of cancer for women with saline or silicone implants compared to other women, and the other showed an increase risk of death from brain cancer or lung diseases among women with saline or silicone implants, compared to other plastic surgery patients. (DANIELLE - PLEASE provide link here TO OUR PRESS RELEASE ON THIS TOPIC FROM LAST YEAR). Why didn’t the FDA provide the data to their own Advisory Panel, or at least mention the studies, since one of their own scientists helped conduct the research?

What Next?

The bottom line: more than 250,000 women underwent implant surgery last year, more than 200,000 of them to increase the size of their healthy breasts. At the same time, 60,000 women had their implants removed. The Mentor study is too poorly done to be published in a medical journal, but the Inamed study should be published and made widely available so that plastic surgeons and their patients will know that serious complications are very common. Patient advocates hope that the FDA will develop a booklet for plastic surgeons and revise their consumer publications on breast implants to include the Inamed study and the cancer studies.

What happens to women who have had breast augmentation or breast reconstruction for 15 or 20 years? Almost 40 years after silicone breast implants were invented, we still know very little about their long-term safety.

Zuckerman, Ph.D., is president of the National Center for Policy Research (CPR) for Women & Families, a nonprofit research center that provides health information about women, children, and families.