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Myrl Jeffcoat myrlj@jps.net

3 mai, 2005 01:47

Jana Kueck Testimony - FDA Panel Hearings - April 2005

MS. KUECK: Good morning. My name is Jana Kueck, and I'm a registered nurse from Branson, Missouri and a sister of an injured breast implant consumer. I've been a registered nurse for 21 years. My background includes labor and delivery, newborn nursery, and assisting new mothers as a former breast?feeding educator. I have no financial relationship with the PMA sponsors, their products, and their competitors.

Numerous studies have found that breast?feeding provides newborns with essential nutrition and improved resistance to infections. By impeding or preventing breast?feeding, implants have become a public and pediatric health problem as they are essentially depriving newborns from these benefits.

According to the Institute of Medicine, any kind of breast surgery, including breast implant surgery, makes it three times more likely that women trying to breast?feed will have inadequate milk supply or lactation insufficiency.

In a study conducted by Marianne Neifert and colleagues of the University of Colorado at Madison, women who had breast surgery were three times more likely to have lactation insufficiency than those that did not have surgery. The doctors compared the rate of weight gain of breast?fed infants born to mothers who either did or did not have previous breast surgery. Mothers whose babies did not gain at least one ounce per day or required supplemental feedings with formula were deemed to have lactation insufficiency.

Interestingly, the women who had breast surgery through an incision in the nipple area or periareolar incision had a higher incidence of problems. Those women were more likely to suffer from insufficient milk supply.

I frequently have observed decreased milk production in mothers of breast?implanted surgery. In addition, implanted mothers' infants also had difficulty latching onto the breast due to the firmness, usually caused by capsular contracture, even a mild contracture, from the implants.

We don't know how silicone breast implants affect what is in the mother's milk, but it is certainly worthy of more study. Recent research suggesting platinum in breast milk due to the platinum used as a catalyst in silicone breast implants concerns me a great deal.

Because of what is known and what is yet not known about the risk of implants on breast?feeding, I am asking you to vote against the approval of Mentor's and Inamed's application. Voting against approval will support women's health and the health of precious newborns.

Thank You.

 


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