Breast Implants Aren’t For Life, FDA Warns

November 12, 2012

Breast Implants Aren’t For Life, FDA Warns

The United States Food and Drug Administration (FDA) announced that all women with silicone breast implants will need surgery within 10 years to fix complications. Silicone breast implants may cause burst open and anaplastic large-cell lymphoma, a cause a rare form of cancer. The FDA’s Center for Devices and Radiological Health claims that the longer a woman keeps her silicone implants, the higher her chances are for developing complications. Other groups are taking the FDA to task for their choice of studies, noting that a proper study of the long-term effects of silicone breast implants has yet to be done. Still, even the FDA’s warnings are not expected to slow down the demand for breast enhancement surgeries. Once Banned in USA The FDA based these announcements on several long-term studies from 1997 – 2010. Before each brand of silicone breast implant is approved by the FDA, the manufacturer is required to perform a 2 -10-year study. Currently, manufacturers do not have to perform longer studies. Silicone breast implants were banned in America from 1992 – 2006 when many women claimed the implants made them dreadfully sick. When the FDA lifted the ban in 2006, it did on the condition that silicone breast manufacturers fund and implement studies on the long-term effects of their products. At least 40,000 women were to be included for each study. But no clinical study could positively link silicone breast inserts to any illness until now.

Other Complications

Besides rupturing and possiblilty for cancer, the FDA listed many other reasons a woman may need surgery to remove or replace her silicone implants. These included excessive scarring at the surgical site; infections at the incision sites; a strangle wrinkle occurring inside of the implant to cause a deformed breast; one breast growing noticeably larger than the other and pain.

The FDA also noted that a majority of the women with silicone implants were happy with the way the implants looked and felt. However, they did not know if women who dropped out of silicone breast studies still felt happy with their implants as they were when they first received them. Silicone is often preferred by women to saline injections for breast enhancement because silicone feels more like a real breast. The FDA also reported that many women are educated on the possible risks and complications before they undergo breast enlargement surgery.

Controversial Studies

Groups like the National Research Center for Women & Families points out that the studies the FDA looked at were questionable at best. 40% of women dropped out of a major decade-long study made by the silicone breast implant manufacturer Allergan. Another three-year study by the manufacturer Mentor division of pharmaceutical giant Johnson & Johnson only ended with 21% of women it started out with.

Because of these high drop-out rates, the National Research Center for Women & Families recommends that women ignore the FDA’s new warning about silicone implants. Many of the women who chose to drop out of studies did so because of other health problems that may not have anything to do with breast implants. Out of an estimated 5 to 10 million women who received implants from 1997 – 2010, only 60 were diagnosed with anaplastic large-cell lymphoma. An estimated 3,000 Americans are diagnosed with the cancer each year.

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