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Breast Implants Chronology

A chronology of major developments in breast implants:

1992: The FDA bans silicone-gel breast implants, except for patients with breast cancer and certain other conditions that could get them through specially monitored research studies. Implants filled with saline or salt water, were not restricted and were the only option left for cosmetic enlargement in the USA.

1999: The Institute of Medicine, an advisory arm of the National Academies, says there was no evidence linking breast implants to serious illnesses, but that breaking, pain and other local complications may occur.

2000: The FDA re-evaluates saline-filled implants and declares them safe enough to continue selling if women are warned about high breakage and replacement rates.

2003: Inamed Corp. asks the FDA to approve its silicone-gel implants in the USA.

2003 October, a panel of FDA scientific advisers recommends that the implants be allowed to return to the US market.

January 2004: The FDA rejects Inamed's bid to bring silicone-gel implants back to market and asks the company for more information to ensure the implants are safe.


In keeping the implants off the market for the time being, FDA took the highly unusual step of rejecting the recommendation of its own scientific advisers, who in October had reluctantly agreed the devices should return despite some lingering questions about safety and durability.

Inamed said the company would seek approval again after learning exactly what additional information the government will require as proof that silicone gel implants are safe enough to sell.

Silicone implants do not cause major disease

The Institute of Medicine, an arm of the National Academy of Sciences, recently concluded that women with silicone breasts implants are no more likely than the rest of the population to develop serious illnesses. The report said new studies have led to, among others, the following conclusions:

  • There is no evidence suggesting silicone used for breast implants is toxic to humans.
  • There is no established link between implants and unique disease syndrome. Problems ascribe to implants generally involve symptoms that are non-specific and common in the general population.
  • Although breast cancer is not higher in women who have implants, the presence of implants makes it difficult to detect cancer through mammography, especially when the implants are placed subcutaneous or above the muscle.
  • The report also notes that, in the U.S., ten million people have some type of implants, such as an artificial joint or pacemaker, which is made at least, in part, by silicone.
  • Breast-Feeding is OK. It is important to note that higher levels of silicon have been found in cows' milk and commercially available infant formula than are found in the breast milk of women with implants.
  • Breast implants do not last forever: risks of rupture accumulate over time. Many women should expect to have more than one implant.

In addition to the Institute of Medicine, many other respected medical professionals and institutions have conducted scientific studies about the safety of breast implants over the past years. The full text of the publication, "Information for Women about the Safety of Silicone Breast Implants - A Report of a Study by the Institute of Medicine," is available online at
www.nap.edu or
  http://books.nap.edu/books/0309065933/html/1.html

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