From Zuckerman: New study on breast cancer patients with implants

[Guest guest]

--- Zuckerman <dz@...> wrote:

> From: " Zuckerman " <dz@...>

> <ifriends@...>

> Subject: Fw: new study on breast cancer patients

> with implants

> Date: Tue, 20 Dec 2005 09:50:15 -0500

>

> Dear Friends,

>

> A newly published study finds a high rate of

> complications within 2 years of mastectomy patients

> getting reconstruction with breast implants. As I

> point out in the AP story and our press release

> (below), the study is funded by Dow and

> underestimates complications by studying women for a

> short period of time and by not using MRIs to test

> for rupture and leakage. If they had done so, the

> rates would have been even higher.

>

> This is yet another reason why we are concerned

> about the FDA returning silicone breast implants to

> the market.

>

>

> Zuckerman, Ph.D.

> President

> National Research Center for Women & Families

> 1701 K Street, NW, Suite 700

> Washington, DC 20006

> (202) 223-4000

> www.center4research.org

>

> Remember us when you donate to United Way or CFC --

> we're # 9884

>

> 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.

>

>

>

> 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 s 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.

>

>

>

> ------

>

>

>

>

>

>

>

> PR Newswire

>

> December 19, 2005

>

> Statement of Dr. Zuckerman, Ph.D. President,

> National Research Center for Women & Families

>

>

>

> WASHINGTON, Dec. 19 /PRNewswire/ -- Dr.

> 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/

>

>

>

> 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/

>

>

>