About 300,000 women in the United States have their breasts surgically enlarged each year and worldwide, 5 to 10 million women have such breast implant procedures. Back in 2006, the FDA approved Allergan and Mentor silicone gel filled breast implants (as opposed to saline) for breast reconstructive surgery and for breast enlargement in women aged 22 and older. However, one in five women that receive silicone implants need to have these devices removed within 10 years due to complications, and as many as half of women who receive implants for reconstruction after breast surgery, will need them removed within the same time frame.

The FDA will take a look at improving procedure safety this week and update the medical community.

Silicone implants had been banned prior to 2006 because of concerns about possible links to several diseases, including cancer and lupus. Other common complications included hardening of the area around the implant and the need for additional surgeries and implant removal. The FDA also notes other frequent problems include implant rupture, wrinkling, breast asymmetry, scarring, pain and infection.

The FDA said it wants to find ways to improve post-approval safety studies and to identify new approaches to mandated studies and surveillance of silicone implants that are likely to yield valuable information on their safety and performance.

The FDA announced:

“This meeting is regarding the discussion of different innovative methodological approaches to the conduct of post market studies regarding silicone gel breast implants. Additionally, the panel will discuss key long-term safety issues associated with silicone gel breast implants in the real-world setting.”

Two major new studies raise questions about the long-term safety of breast implants. A team of researchers led by Louise Brinton, Ph.D., of the National Cancer Institute (NCI) recently published these studies on the long-term health effects of breast implants. One of the studies found that women with breast implants are more likely to die from brain tumors, lung cancer, other respiratory diseases, and suicide compared to other plastic surgery patients. The other study found a 21% overall increased risk of cancer for women with implants, compared to women of the same age in the general population.

These studies are the first to look at all types of cancer and all causes of death among breast implant patients. While the authors were not able to determine whether implants caused these illnesses, the results show a doubling of brain cancer and a tripling of lung cancer, emphysema, and pneumonia for women with implants. Even though these findings were described as “unexpected,” they are consistent with previous research that shows brain abnormalities and lung problems related to breast implants. There was also a four-fold increase in suicide for breast implant patients, which seems to contradict the manufacturers’ assertion that implants improve a woman’s feeling of self-worth.

Although the FDA has also recently cautioned that breast implants might be linked to a higher risk of a rare form of lymphoma called anaplastic large cell lymphoma, officials called those chances slim.

Presently, the FDA recommends that women follow-up regularly with their doctor, which includes occasional MRIs to detect potential ruptures. It is also important to pay attention to any changes and notify their health-care provider if they notice any unusual symptoms such as pain, asymmetry or swelling, and educate themselves on the signs and symptoms of complications.

Written by Sy Kraft