Inamed Breast Implant Research Shortchanges Breast Cancer Patients

Statement by Dr. Diana Zuckerman, President, National Research Center

for Women & Families on FDA 'Approvable' Letter for Breast

Implant Manufacturer



21 Sep, 2005, 01:00 ET from National Research Center for Women & Families

    WASHINGTON, Sept. 21 /PRNewswire/ -- BACKGROUND -- Today the Food and Drug
 Administration (FDA) issued an "approvable letter" to Inamed Corporation for
 their silicone gel breast implants.  Inamed Corp. was granted this first step
 in the approval process based on a revised application that is missing most of
 its breast cancer patients. After their application was rejected by the FDA a
 few months ago, Inamed belatedly decided to eliminate a defective style of
 breast implant (Style 153) from their application for approval.
 Unfortunately, two-thirds of the breast cancer patients in their study had
 this defective style of implant, which had a tendency to break even during the
 first three years in the body.  When the company resubmitted their
 application, they removed those women from their study, apparently leaving
 fewer than 30 breast cancer patients who underwent MRIs to determine if their
 implants had ruptured or were leaking silicone.  Yet the agency had asked that
 at least 250 breast cancer survivors be studied.  In August, the Mentor
 Corporation also received an approvable letter.
 
     STATEMENT -- "It is absolutely unacceptable to approve a breast implant
 that hasn't been carefully studied to make sure it is safe for breast cancer
 patients.  Sadly, this isn't the first time -- rival implant maker Mentor's
 long-term data included zero breast cancer patients.
     "The approvable letter was sent despite FDA scientists' scathing
 criticisms of the company's data and a vote from FDA's advisory panel
 recommending that the implants not be approved.  This action by the FDA once
 again raises questions about whether the agency is making decisions based on
 scientific evidence.
     "This sounds familiar.  Just a few weeks ago, the FDA ignored their own
 scientists when they refused to approve the morning-after pill for over-the-
 counter sales.  Once again, the FDA is ignoring the concerns of their own
 scientists, this time potentially endangering breast cancer survivors.
     "Only scientific evidence and solid safety data can protect women.
 Wishful thinking should not be a basis for approval."
 
     CONTACT:  Dr. Diana Zuckerman of National Research Center for Women &
 Families, +1-202-223-4000, or dz@center4research.org.
 
 

SOURCE National Research Center for Women & Families
    WASHINGTON, Sept. 21 /PRNewswire/ -- BACKGROUND -- Today the Food and Drug
 Administration (FDA) issued an "approvable letter" to Inamed Corporation for
 their silicone gel breast implants.  Inamed Corp. was granted this first step
 in the approval process based on a revised application that is missing most of
 its breast cancer patients. After their application was rejected by the FDA a
 few months ago, Inamed belatedly decided to eliminate a defective style of
 breast implant (Style 153) from their application for approval.
 Unfortunately, two-thirds of the breast cancer patients in their study had
 this defective style of implant, which had a tendency to break even during the
 first three years in the body.  When the company resubmitted their
 application, they removed those women from their study, apparently leaving
 fewer than 30 breast cancer patients who underwent MRIs to determine if their
 implants had ruptured or were leaking silicone.  Yet the agency had asked that
 at least 250 breast cancer survivors be studied.  In August, the Mentor
 Corporation also received an approvable letter.
 
     STATEMENT -- "It is absolutely unacceptable to approve a breast implant
 that hasn't been carefully studied to make sure it is safe for breast cancer
 patients.  Sadly, this isn't the first time -- rival implant maker Mentor's
 long-term data included zero breast cancer patients.
     "The approvable letter was sent despite FDA scientists' scathing
 criticisms of the company's data and a vote from FDA's advisory panel
 recommending that the implants not be approved.  This action by the FDA once
 again raises questions about whether the agency is making decisions based on
 scientific evidence.
     "This sounds familiar.  Just a few weeks ago, the FDA ignored their own
 scientists when they refused to approve the morning-after pill for over-the-
 counter sales.  Once again, the FDA is ignoring the concerns of their own
 scientists, this time potentially endangering breast cancer survivors.
     "Only scientific evidence and solid safety data can protect women.
 Wishful thinking should not be a basis for approval."
 
     CONTACT:  Dr. Diana Zuckerman of National Research Center for Women &
 Families, +1-202-223-4000, or dz@center4research.org.
 
 SOURCE  National Research Center for Women & Families