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Healthy Skepticism Library item: 3071

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

 

Publication type: news

Tanner L.
Implants, Mastectomies Linked to Problems
Associated Press 2005 Dec 19
http://web.archive.org/web/20070101054444/http://www.sfgate.com/cgi-bin/article.cgi?f=/n/a/2005/12/19/national/a132302S36.DTL&type=health

Keywords:
silicone breast mastectomies implants


Notes:

Diana Zuckerman’s Comments:

PR Newswire
December 19, 2005
Statement of Dr. Diana Zuckerman, Ph.D. President, National Research Center for Women & Families

WASHINGTON, Dec. 19 /PRNewswire/ — Dr. Diana Zuckerman, Ph.D. issued the following statement regarding today’s release of the article “Reconstructive Breast Implantation After Mastectomy for Breast Cancer” in the journal Archives of Surgery (December 2005):

“The study published today by researchers from the International Epidemiology Institute, and funded by Dow Corning, provides important information about the high complication rate for silicone gel breast implants used for reconstruction after breast cancer. However, the complication rate found in this study is less than half as high as those reported in other studies, because there are serious shortcomings in the study design.

“The study reported that 21% of the women needed additional surgery, 31% developed at least one serious complication, and 16% developed at least 2 serious complications. Those statistics are very worrisome, given that these women had breast implants for anywhere from 7 weeks to 4 years, with an average of only 23 months. A slightly longer-term study of Inamed silicone implants presented by FDA scientists in 2003 found that 46% of reconstruction patients needed additional surgery within the first 2-3 years. That’s more than twice as high as the rate reported in the study released today. Previous research has shown that new complications occur every year, with complications requiring additional surgery tending to increase over time.

“The authors of this study conclude that ‘reconstruction failure (loss of implant) is rare,’ which is not surprising given the short period of time that the patients had their implants. However, the failure rate is probably considerably higher than reported. This new study did not use Magnetic Resonance Imaging (MRIs) to detect rupture, and did not mention that MRIs are the primary way to accurately detect implant rupture or leakage for silicone gel breast implants. By failing to use MRIs, the authors are undercounting the number of ruptures. This also would help explain the lower rate of additional surgery. If a woman underwent a MRI and then found out her implants were ruptured, she would probably have surgery to remove them (to avoid silicone leaking into her lymph nodes or other parts of her body).

“At the April 2005 FDA advisory panel meeting, a study in which women were given MRIs in the first and third year after implantation found that 20% of the reconstruction patients had ruptured implants by the third year. Almost none of those ruptures were detected without the MRIs. Many of the women had their implants removed when they learned they were ruptured.

“Overall, the study shows that, even when complications are minimized because of shortcomings in the study design, many breast cancer patients will have complications and need additional surgery after undergoing breast reconstruction with silicone gel breast implants.”

The National Research Center for Women & Families (NRC) is a nonpartisan, nonprofit research and education organization that works to improve policies and programs that affect the health and safety of women, children, and families. http://www.center4research.org/

Diana Zuckerman, Ph.D, has post-doctoral training in epidemiology from Yale Medical School. Prior to her current position, she was a faculty member at Vassar and Yale, a researcher at Harvard, a Congressional staffer in the U.S. House of Representatives and U.S. Senate, and a senior policy advisor in the White House at the Office of Science and Technology Policy.

National Research Center for Women & Families

Web site: http://www.center4research.org/


Full text:

Associated Press
December 19, 2005
Implants, Mastectomies Linked to Problems
By LINDSEY TANNER

CHICAGO (AP) – Breast implants in women who have undergone mastectomies often result in complications that require more surgery, a study in Denmark found.

Over a period of up to four years, about one-third developed at least one potentially serious complication, including thick, tight scarring and infections, the researchers reported. Implant ruptures were rare, with only five reported among the 574 Danish women studied.

Overall, about 20 percent of the women studied required surgery to treat the problems, according to the study by Danish Cancer Society researchers and scientists at the International Epidemiology Institute in Rockville, Md.

One surgeon said in an accompanying editorial that the numbers are “alarmingly high and arguably unacceptable.”

The study appears in the December issue of Archives of Surgery. It was paid for by the institute, which receives funding from the Dow Corning Corp., a former maker of silicone breast implants.

Diana Zuckerman, president of the National Research Center for Women and Families, said the complication rate for implants in mastectomy patients is actually much higher than the study suggests.

Most participants got implants several weeks after breast removal surgery, whereas most U.S. mastectomy patients who choose implants get them when their breasts are removed, Zuckerman said. That method, involving a single round of surgery, is often easier psychologically because women wake up from their mastectomies with refashioned breasts, but it is also more stressful on the body, she said.

Also, she said the participants in the study did not undergo MRI scans, which are the best way to detect ruptures.

“This study is really missing the boat,” said Zuckerman, whose group has opposed efforts to return silicone implants to the market.

All of the women studied got implants, most of them made of silicone.

Silicone implants have been restricted in the United States for over a decade because of fears that ruptures and leakage might damage women’s health. But some mastectomy patients have continued to receive them.

The American Cancer Society estimates more than 200,000 U.S. women will be diagnosed with breast cancer this year. At least half will have mastectomies, and Zuckerman said about two-thirds of those patients choose some type of reconstructive surgery.

Many have breasts fashioned from excess flesh from their abdomens — a method that is less likely than implants to result in thick scars and generally requires fewer “revisional” operations, said Dr. Navin Singh, a Johns Hopkins University surgeon and author of the accompanying editorial.

Singh said mastectomy patients are more prone to complications than healthy women seeking implants for purely cosmetic reasons, because much of their breast tissue and surrounding skin are removed during cancer surgery, giving doctors less to work with.

Also, some mastectomy patients may undergo radiation and chemotherapy, which can increase the risk of implant complications, he said.

Meredith Cobb, a hot line counselor for the Chicago-based breast cancer advocacy group Y-ME, said her silicone implants are not symmetrical and she needs more surgery to fix them. Still, the Colorado Springs, Colo., woman, who was diagnosed with breast cancer in 2003 at 26, said her implants have helped her “feel whole again.”

“I wouldn’t give them up now,” she said. “A lot of people might not go through another surgery, but it’s something that I’m willing to do,” Cobb said.

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