Statement of Dr. Diana Zuckerman, Ph.D. President, National Research Center for Women & Families

19 Dec, 2005, 00:00 ET from 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.
 
 

SOURCE 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.
 
 SOURCE  National Research Center for Women & Families