Breast implant surveillance reports to the U.S. Food and Drug Administration: maternal-child health problems.
There is continuing concern that women who receive breast implants may be at increased risk for adverse reproductive outcomes or experience problems with breastfeeding. It is unknown whether exposure to biomaterials in breast implants may have teratogenic effects or leach into breast milk causing postnatalproblems. We studied the Food and Drug Administration (FDA) experience by analyzing a case series of adverse event reports received and entered into the FDA's Manufacturer and User Facility Device Experience (MAUDE) database or the Device Experience Network (DEN) database by December 31, 2002 regarding women with breast implants. Reports were critically reviewed for lactation difficulties, reproductive problems (spontaneous abortion, delayed conception) and medical conditions among offspring, including neonatal, infant, and childhood diseases and congenital defects that were attributed to implants. We identified 339 reports that described maternal-child adverse events. Nearly half of these reports (46%) described actual problems with breastfeeding or expressed concern that implants would be unsafe or interfere with breastfeeding. Forty-four percent of reports (n=149) described either nonspecific or specific signs, symptoms, or illnesses in children. An additional 3.5% of reports (n=12) detailed a congenital anomaly believed by the reporter to be caused by breast implants.
Brown
S Lori
SL
Division of Postmarket Surveillance, Office of Surveillance and Biometrics, Center for Devices and Radiological Health Food and Drug Administration, Seattle District Office, Bothell, WA 98021-4421, USA. lori.brown@fda.hhs.gov
Todd
Joan Ferlo
JF
Cope
Judith U
JU
Sachs
Hari Cheryl
HC
D000293:Adolescent; D001942:Breast Feeding; D019928:Breast Implantation / Q000009:adverse effects*; D018427:Breast Implants / Q000009:adverse effects*; D002648:Child; D002675:Child, Preschool; D000013:Congenital Abnormalities / Q000209:etiology; D016208:Databases, Factual; D005260:Female; D006801:Humans; D007223:Infant; D007231:Infant, Newborn; D007247:Infertility, Female / Q000209:etiology; D008297:Male; D011247:Pregnancy; D011248:Pregnancy Complications / Q000209:etiology; D011297:Prenatal Exposure Delayed Effects; D012307:Risk Factors; D020034:Silicone Gels; D012965:Sodium Chloride; D014481:United States; D014486:United States Food and Drug Administration
D020034:Silicone Gels; D012965:Sodium Chloride