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Journal of Long-Term Effects of Medical Implants

ISSN Print: 1050-6934
ISSN Online: 1940-4379

Journal of Long-Term Effects of Medical Implants

DOI: 10.1615/JLongTermEffMedImplants.v16.i4.20
pages 281-290

Breast Implant Surveillance Reports to the U.S. Food and Drug Administration: Maternal-Child Health Problems

S. Lori Brown
Division of Postmarket Surveillance, Office of Surveillance and Biometrics, Epidemiology Branch, Center for Devices & Radiologic Health, Food and Drug Administration, c/o Seattle District Office, 22201 23rd Dr. SE, HFR-PA300, Bothell WA 98021-4421
Joan Ferlo Todd
Division of Postmarket Surveillance, Office of Surveillance and Biometrics, Center for Devices and Radiological Health, Food and Drug Administration, Rockville, MD
Judith U. Cope
Division of Postmarket Surveillance, Office of Surveillance and Biometrics, Center for Devices and Radiological Health, Food and Drug Administration, Rockville, MD
Hari Cheryl Sachs
Division of Pediatric Drug Development, Office of Counterterrorism and Pediatric Drug Development, Center for Drug Evaluation and Research, Food and Drug Administration, Standish Place, Rockville, MD

ABSTRACT

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 postnatal problems.
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.