Study of Children Breastfed by Women with Breast Implants

[Guest guest]

Answers 01/21/1994

T94-6

Cruzan

Jan. 21, 1994 (301)

443-3285

STUDY OF CHILDREN BREASTFED BY WOMEN WITH BREAST

IMPLANTS

FDA is receiving inquiries about a preliminary

study reported in the Jan. 19 Journal of the American

Medical Association suggesting that breastfed children

of women with silicone gel breast implants may be at

risk of developing abnormal esophageal motility. This

is a reduction in the normal wave-like motion of the

esophagus that moves food toward the stomach. FDA

believes that the study is inconclusive and

preliminary, and further studies are needed before any

conclusions should be drawn from it.

Abnormal esophageal motility is seen in a number

of other disorders, but often appears in children with

systemic sclerosis, an autoimmune disease. There have

been allegations that leaking silicone could cause

autoimmune diseases.

The study evaluated 11 children between one and a

half and 13 years old with chronic gastrointestinal

problems, who had been born to women with silicone

breast implants. The problems experienced by these

children included abdominal pain with at least one of

the following: vomiting, difficulty in swallowing or

poor weight gain.

Eight of the 11 children had been breastfed, while

the remaining three children had been exclusively

bottle fed. Six of these eight breastfed children had

significantly abnormal lower esophageal motility

compared with the three bottle fed children and with

another group of children whose mothers did not have

breast implants.

Based on these results, the authors state that a

relationship may exist between breastfeeding by some

mothers with silicone implants and abnormal esophageal

motility in their children. The authors suggest this

may occur through the mother's " immunologic factors "

transmitted through the breast milk or through

substances leaking from the implant. However, they

acknowledge that further study is needed before

definite conclusions can be drawn. An editorial

published in the same issue cautions that these

results have not been confirmed.

FDA had been aware that this study was in

progress, based on information previously presented by

these authors at a scientific meeting. The agency

views this study with interest, but the limitations of

the study design including, for example, the small

size of the study and selection bias, limit

conclusions that can be drawn from it.

FDA agrees with the study's conclusion that more

research is needed. The agency is encouraged that

physicians are taking patient complaints seriously and

that they are pursuing further research.

There is no widely available, standardized test

to detect silicone in the body. Some large,

sophisticated research laboratories are able to detect

the presence of silicone or silicon (an indirect

measure of silicone) in blood, tissue and urine, but

the meaning of these test results is unknown. Even if

simple techniques to detect silicone were available,

they might not be useful in detecting a breast implant

rupture because small amounts of silicone ordinarily

" bleed, " even from intact implants. Further, since

silicone is found in food and many other products,

including commonly used medicines and cosmetics, it

would be hard to determine whether the silicone came

from the implant or another source.

The current informed consent document given to

women who enter the silicone breast implant clinical

trial stresses that only limited research has been

conducted in this area and further study is needed

(see talk paper T92-35). Women with implants

considering breastfeeding are urged to check with

their doctors or FDA's Breast Implant Information Line

at (800) 532-4440 for the most current information.