Breast Implant Complications Booklet

(Note: On this webpage the FDA includes a photo of a patient who’s opted for breast implant removal without replacement. They state a risk of this decision is:

Women who do not have their implants replaced may have cosmetically undesirable dimpling, puckering, or sagging of the natural breast following implant removal.

Click Here to Read More

This is true but only if the patient opts not to have a breast lift and/or fat grafting. See sections on Breast LIfts and Fat Grafting with before and after photos.

FDA News Release

The Food and Drug Administration (FDA) is an agency within the U.S. Department of Health and Human Services. In regards to medical devices such as breast implants, it exists to protect the public health by assuring the safety and effectiveness of these products.

http://www.fda.gov/newsevents/newsroom/pressannouncements/ucm340447.htm

Breast Implants

The FDA defines breast implants as “medical devices that are implanted under the breast tissue or under the chest muscle to increase breast size (augmentation) or to rebuild breast tissue after mastectomy or other damage to the breast (reconstruction). They are also used in revision surgeries, which correct or improve the result of an original surgery.”

The purposes of the FDA website regarding breast implants are also outlined.

http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/BreastImplants/default.htm

Implant Safety and Protecting Health

The FDA gained regulatory authority over breast implants in 1976. In 1988 it re-classified breast implants, calling for submission of premarket approval applications. Up to that point, or since 1962 of the first breast implant created using silicone, devices had not been tested for safety.

Whether or not silicone implants and/or the shell can cause autoimmune disorders is still a subject of controversy. However, the FDA states there’s not sufficient evidence to conclude any connection. Other groups, including experts in the field, contend otherwise, saying there have been no long-term studies to rule out the possibility.

Included is a downloadable pdf file for both English and Spanish.

Reports of Anaplastic Large Cell Lymphoma (ALCL) in Women with Breast Implants: FDA Safety Communication

http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm240000.htm

Breast Implant Resource Groups

http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/BreastImplants/ucm063728.htm

Contraindications

http://www.accessdata.fda.gov/cdrh_docs/pdf12/P120011c.pdf

Breast implant surgery should NOT be performed in:

  • Women with active infection anywhere in their bodies
  • Women with existing cancer or pre-cancer of their breast who have not received adequate treatment for those conditions
  • Women who are pregnant or nursing

Mammographic procedure and techniques for mammography of patients with breast implants.

http://www.fda.gov/radiation-emittingproducts/mammographyqualitystandardsactandprogram/guidance/policyguidancehelpsystem/ucm050244.htm

FDA Backgrounder on Platinum in Silicone Breast Implants

http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/BreastImplants/ucm064040.htm

OTHER RESOURCES ON BREAST IMPLANT SAFETY

http://www.nap.edu/openbook.php?record_id=9618&page=20

“Mammograms and Other Breast Imaging in Women with Implants .” Information for Women about the Safety of Silicone Breast Implant. Washington, DC: The National Academies Press, 2000, pp. 21-34.

http://www.nap.edu/openbook.php?record_id=9618&page=21

National Center for Health Research

http://center4research.org/nrc-in-the-news/news-analysis-interviews-op-eds-editorials/fda-concludes-silicone-breast-implants-mostly-safe/

http://center4research.org/medical-care-for-adults/breast-implants-and-other-cosmetic-procedures/breast-implants-a-research-and-regulatory-summary/

Breast Implant Information: Sponsored by The National Research Center for Women & Families

http://www.breastimplantinfo.org/aascientific-research/