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History of Silicone gel breast implants

Specialist in silicone gel breast implants, breast augmentation, and breast implant exchange for Virginia, West Virginia, Maryland, & Washington DC

Visit our Virginia breast augmentation overview.

Breast augmentation surgery was first reported in the mid 1800s.  The earliest known breast implant surgery took place in Germany.  The fat from a benign tumor that was removed from a woman's back was then implanted in her breast.  In the following years, the medical community experimented with various breast implant materials, most frequently paraffin.  Japan was the first to use silicone as breast implant material following World War II.  Japanese doctors would inject silicone directly into women’s breasts.  This proved to be unsafe and very dangerous.

Two Houston plastic surgeons developed the silicone breast prosthesis with the Dow Corning Corporation, in the early 1960s.  Their first breast implant consisted of a silicone rubber envelope or sac filled with a thick, viscous silicone gel.  In 1962, a woman was implanted with the first self contained silicone breast implant.  In 1965, the saline-filled breast implants were introduced.

In the early 1970s, several companies began mass-producing breast implants.  More options became available, in 1974, with the introduction of inflatable breast implants.  Soon after the mid 1970s, double pocket breast implants appeared on the market; these breast implants had an inner chamber filled with silicone gel and an outer chamber filled with saline. 

An important landmark was created by the FDA, in 1976, when it passed the Medical Devices Amendment to the Federal Food, Drug and Cosmetic Act.   This amendment gave the FDA the authority to review and approve the safety and effectiveness data of new medical devices.  Since silicone gel breast implants had been on the market for almost 15 years by that time, they were ‘grandfathered.’  Also around this time, a Houston attorney won the first lawsuit against silicone breast implants.  A Cleveland woman claimed that her ruptured silicone-gel breast implants and consequent operations had caused her pain and suffering.

By the late 1980s, textured-surface breast implants were introduced on with the idea that the textured shell would alter the process of scar formation and reduce the occurrence of capsular contracture; ongoing medical studies of this textured shell have shown mixed results as to the efficacy of decreasing capsular contracture.  During the '70s and '80s, plastic surgeons continued to gain significant medical experience with breast implants and found that women are pleased with the results after breast augmentation surgery. 

In the early 1990s, breast implants became the subject of controversy as reports of women with breast implants becoming seriously ill.  The concern that silicone-gel breast implants could possibly be causing serious health issues became widely publicized. “Face to Face with Connie Chung,” broadcasts about the dangers of silicone gel breast implants.  In 1991, breast implant manufacturer, Dow Corning, lost a lawsuit based on claims that its breast implants were the cause of a woman’s autoimmune disease.

In January of 1992, the FDA issued a voluntary breast implant suspension and the agency banned the use of silicone-gel breast implants for breast augmentation.  Breast reconstruction surgery, breast lift surgery and breast implant exchange surgery became the only few surgery exceptions permitted to use silicone-gel breast implants.  The controversy arose from the breast implant manufacturers not having sufficient information to completely address some of the safety issues that had arisen.  While this debate continued, saline breast implants continued to be widely available to the general public for breast augmentation surgery.  By 1994, anatomical or tear dropped shaped breast implants were developed and was intended at create a more natural sloped breast contour.  However, this has been proven not to be necessary to achieve natural shaped breasts.

In the early 2000s, the National Academy of Sciences’ Institute of Medicine report found No Scientific Evidence of a connection between silicone-gel breast implants and connective tissue diseases.   In 2002, Mentor and Inamed (two major breast implant manufacturers) submitted their silicone-gel breast implant pre market approval requests.  Silicone-gel breast implants from Mentor were approved under regulatory conditions limiting their use to breast lifts, congenital or traumatic deformity, or a revision/ replacement, and only when certain conditions are present.  

In 2006, the Food and Drug Administration (FDA) listened to testimony from a variety of people both for and against the sale of silicone-gel breast implants.  The panel of plastic surgeons and other medical specialists then voted to lift silicone gel breast implant restrictions.  Silicone gel breast implants are now available to women for primary breast augmentation, who are at least 22 years of age.

When searching about silicone gel breast implants and minimizing risk in Northern Virginia, Maryland or Washington,DC, plastic surgeon, Dr. Michael J. Brown is an excellent choice to have this procedure from. His patients come from Loudoun, Fairfax, Reston, Herndon, Leesburg, Dulles, Ashburn, Middleburg, Great Falls, Potomac Falls, Alexandria, Vienna, Falls Church, Chevy Chase, Bethesda, Potomac, Richmond,Washington, DC to name a few areas

For an overview of silicone gel breast implants continue reading here. You can read more about silicone gel breast implant safety and on going studies.

To learn more about breast augmentation surgery, click to review more of an overview of breast augmentation. To learn about breast anatomy and breast implant positioning you may want to start here.

To see the steps of breast augmentation using 3-D illustrations, visit the breast implant surgery page. For more information click on the icon above or to see the actual breast augmentation surgery be performed on a live person, visit one of Dr. Brown's breast specific web sites.

Prior to any surgical procedure, it is imperative that you have read and understand the consent forms required for a plastic surgical procedure.

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