Based on anecdotal data, false claims and unfounded science, the safety of silicone-filled breast implants was questioned in the 1990s. This resulted in an epidemic of patient anxiety, unnecessary implant removals, litigation, and an almost 20-year FDA imposed moratorium on their use.
However, laboratory and clinical studies conducted by plastic surgeons, together with the industry, have since demonstrated the safety of silicone breast implants. These findings prompted the FDA to once again approve silicone implants for breast reconstruction and breast enhancement only a few years ago.
Yet on January 26, 2011, the FDA announced a possible association between breast implants and a type of cancer - anaplastic large cell lymphoma (ALCL).
ALCL is a rare cancer of the immune system, which can occur anywhere in the body. Only one in 500,000 women in the U.S. is diagnosed with ALCL every year. In a thorough review of scientific literature published from January 1997 through May 2010, the FDA identified 34 unique cases of ALCL in women with breast implants throughout the world.
According to the American Society of Plastic Surgeons, nearly four million breast implant procedures were performed in the United States from 1998 to 2009. The total number of implants worldwide is estimated to be between 5-10 million. That means that ACLC in women with breast implants is an extremely rare occurrence.
When breast implants are placed in the body, they are inserted behind the breast tissue or under the chest muscle. Over time, a fibrous scar called a capsule develops around the implant, separating it from the rest of the breast. In women with breast implants, the ALCL was generally found adjacent to the implant itself and contained within the fibrous capsule. The typical sign of this problem was swelling around the implant years after surgery, due to accumulation of fluid between the capsule and the implant.
The ALCL in patients with breast implants has demonstrated an indolent course -- or one that is relatively inactive. In most cases treatment consisted of removing the capsule and the implant. Although lymphoma in patients with implants technically fulfills the criteria for classification as ALCL, it may represent a distinct form of disease.
The FDA believes that women with breast implants may have a very small but increased risk of developing lymphoma in the scar capsule adjacent to the breast implant. Yet the FDA also states that the evidence continues to support a reasonable assurance that FDA-approved breast implants are safe and effective when used as labeled.
The FDA does not recommend removal of breast implants and women with implants should continue their normal self exam, and mammography when appropriate. They should report any changes to their plastic surgeon.
The FDA is collaborating with the American Society of Plastic Surgeons to establish a registry of patients with breast implants who have been diagnosed with ALCL. This collaboration, as well as the collection of relevant objective data will hopefully ensure that science rather than hysteria will form the basis for decision making regarding the safety and use of breast implants.