Where Are the Facts on Breast Implants?

Largely influenced by pop culture icons suggesting her breasts were inadequate, Denee Dimiceli felt unhappy about the size of her breasts. At age 27, she opted for breast augmentation despite her spouse’s reassurances that her breasts were fine.

Dimiceli’s decision isn’t surprising. Ads promoting breast augmentation abound. “Envision Your New Breasts!” “Fast Breast Enlargement!” promotions boast. Such ads are proliferating, and they are aimed at younger audiences, who are choosing augmentation at increasing rates.

Wendi Myers had a different experience from Dimiceli’s. She wanted to have her implants removed. Having suffered unexplained dizziness, hair loss, and fatigue, she believed her silicone implants were to blame. When Myers’s implants were removed, she was shocked by the gelatinous material that was excised.

Dimiceli and Myers are featured, along with plastic surgeons and family members, in a film by Carol Cianutti called Absolutely Safe. Cianutti’s mother suffered from the effects of silicone implants, but the film is open-minded, apolitical, and deeply important.

One reason is that breast augmentation has tripled since 1997. In 2013 alone, almost 300,000 women and teenagers had breast-enlarging surgery, using either silicone or saline implants (which are encased in silicone). Another 100,000 breast cancer patients had post-mastectomy reconstruction, often using implants. According to the 2013 Plastic Surgery Statistics Report, breast implants were the most common cosmetic surgery among women ages 20 to 29, with more than 83,600 procedures done.

But what do women know about the safety of breast implants? Not a whole lot, according to the trusted women’s health advocacy group Our Bodies Ourselves. As executive director Judy Norsigian has noted, “One of our challenges is helping the public understand that absence of evidence of harm is not the same as proof of safety. Many people assume breast implants are safe because the FDA allows them to be marketed.”

Karuna Jaggar, executive director of Breast Cancer Action, an activist watchdog organization, agrees. “There’s a shortage of information about the safety of breast implants that limits women’s ability to make truly informed decisions,” she said. “With any procedure it’s always important to balance risks and benefits, but an industry that stands to benefit all too often minimizes risk.”

The FDA did not require companies selling silicone implants to prove their implants were safe until 1991, after they had been used for nearly 30 years. And not until 2000 did the FDA require saline implant manufacturers to prove their implants were safe.

In 2011, two manufacturers were conditionally approved by the FDA to produce silicone implants in the U.S. The two companies were required to conduct 10-year studies on more than 40,000 women with implants. According to the National Center for Health Research (NCHR), a Washington, DC-based health research organization, one of the companies, Mentor, did such a poor job that consumers and public health experts called for the FDA to rescind its approval of Mentor to make silicone implants. The other company, Allergan, lost track of nearly half of their augmentation patients within the first two years.

The dropout rate of patients participating in studies raises important questions. Did patients stop seeing their doctors because the implants were removed? Were they so happy with implants and so problem-free they no longer wanted to participate in studies? Were they too sick to comply? “Patients tell [us] that plastic surgeons are enthusiastic about staying in touch with patients who are satisfied, but not with patients who have problems,” NCHR reports.

One problem with the studies was that they failed to include questions about complications with leaking implants, although women were reporting to the FDA that they suffered from joint pain, hair and memory loss, and other autoimmune symptoms.

Newer research conducted by Allergan followed 455 augmentation patients with first-time implants for at least eight years. Within four years, 24 percent had undergone further surgery to repair an implant problem. One in 10 patients had at least one implant removed. Common complications included loss of nipple sensation, breast pain, and swelling.

The authors of a comprehensive review, “Facts About Breast Implants,” posted by Our Bodies Ourselves in July, spelled out known risks and problems associated with implants. These problems can be localized within the breast and can include infection, chronic pain, numbness, or breakage and leakage. Scar tissue may form, causing breasts to become hard or tight around the implant. Studies conducted by implant manufacturers showed that within three years, approximately three out of four reconstruction (breast cancer) patients and almost half of first-time augmentation patients using either saline implants or silicone gel implants experienced at least one local complication.

Longer-term concerns are also worrisome. Bacteria or mold can grow in saline implants which researchers fear may be released into the body if an implant breaks. The effects of this on women, or nursing babies, have yet to be studied. Other complications of implant breakage—all implants eventually rupture or break—involve silicone migration to lymph nodes and other organs. Migration is still not fully understood, but it is raising increasing concern among researchers and health advocates.

Evidence is mounting that breast implants can make women sick. Some studies suggest that they may be linked to autoimmune diseases such as fibromyalgia. One study found that autoimmune symptoms, including fatigue and joint pain, improved measurably in the majority of women studied who had had their implants removed.

Another concern is that implants can interfere with detecting breast cancer. An estimated 55 percent of breast tumors remain hidden in women with implants, and FDA reports indicate that because of the frequency and fear of ruptured implants, women may forgo mammograms.

Noting that we now live in a “body-changing culture,” Marge Berer, editor of Reproductive Health Matters in the UK, wrote in a 2010 editorial, “in the past 10-15 years, there has been a seismic shift in what is considered possible and desirable to change as regards the bodies we are born with. … Surgery … has now entered the beauty industry. Women are of course the prime targets of this industry.”

It’s worrying that younger women are being targeted by this industry, especially in the absence of sound data regarding the safety of implants. All women need to know the facts about augmentation surgeries and other cosmetic procedures. As Karuna Jaggar puts it, “We must assert the precautionary principle. We can’t assume that chemicals or treatments are safe without sufficient data to be certain of that.”