What women need to know about breast implants linked to cancer

Each year, almost half a million women in the United States choose to get breast implants, either for cosmetic reasons or for reconstructive purposes following cancer treatment.

A few months back, I wrote about breast implants: what they’re made of and the risks of using them.

“Risk” is really putting it mildly. We’re talking about higher chances for developing arthritis, autoimmune disease and cancer.

Around the same time, I told you about the convoluted system of loopholes that allows manufacturers of medical devices, including implants, to throw sand over the potential risks and keep the truth to themselves.

So, why am I writing to you about this again?

Because once again, instead of forcing the hand of manufacturers who won’t deal with the dangers of their product head-on, the FDA is choosing to turn their famous blind eye to the situation.

As a result, thousands of women are developing a deadly disease…

Approve now, test later

Manufacturers of breast implants have very little motivation to be meticulous about the safety of their products.

They can get an implant onto the market after conducting some basic clinical trials, and then are required to continue further research to make absolutely certain their product is safe.

That’s kind of like letting a stranger into your house because they look OK, then once they’re inside, checking to see if they have a weapon.

In 2006, the FDA approved breast implants manufactured by Mentor LLC. In 2013, breast implants made by Sientra Inc. came to market.

As a condition of their product’s approval, the FDA required these two companies (and all manufacturers of implants) to conduct two types of long-term studies to make sure their devices are in fact effective and safe in “real life.”

“Long-term” is the problem here.

Sure, it takes time to see whether women using implants suffer any health issues. But the women then become the guinea pigs, while the manufacturer is free to drag its heels in completing these trials. After all, they’re already selling their product.

Just this year, the FDA issued warning letters to both companies for having failed to comply with these requirements. That’s seven years for Sientra and thirteen years for Monitor — years in which they’ve profited, but not protected the women using their product.

The “slap-on-the-hand” warning letter is little reason for them to jump to attention.

And now, the FDA has decided not to remove from the market a particular type of implant that is turning deadly…

A rare cancer caused by breast implants

In some women, implants may be associated with a constellation of symptoms known as “breast implant illness.” These symptoms include chronic fatigue, pain, cognitive and immune problems.

But there’s a bigger danger.

Anaplastic large-cell lymphoma (BIA-ALCL), a type of non-Hodgkin’s lymphoma, has been linked exclusively to implants that have a rough or textured surface. Surgeons often prefer these because they’re easier to place.

In March, a two-day public forum was held where researchers, patient advocates, and women who have implant-related illnesses spoke out and urged the FDA to ban the use of textured implants.

In the end, only a handful of the FDA panelists seemed to favor this. Most were more interested in exploring the medical and personal family histories that might be making women more vulnerable to this cancer and to implant-related diseases as a whole.

Can you say, “blame the victim”?

The latest FDA statement says the risk of developing BIA-ALCL in women with textured breast implants ranges from one in 3,817 to 1 in 30,000 based on studies reported in medical literature.

This type of implant is manufactured by Mentor and Sientra, who stand by their products.

But 38 countries have pulled one brand of implants, Allergan, off the market. However, all brands are still sold in the U.S.

Make an informed decision

An NBC News investigation in partnership with the International Consortium of Investigative Journalists last fall reported the cancer could be much more common than what the FDA reports — as high as one case out of every 1,000 women with breast implants, according to Australian health officials.

But the FDA said the implants available in Australia are different from those sold in the U.S., which complicates efforts to figure out the true risks.

Clearly, it’s an individual woman’s choice as to whether or not to try breast implants.

But women and patient advocates who spoke at the hearings made it clear that they were under-informed, and even misinformed, about the risks and dangers.

If you or someone you love are considering breast implants, here are some tips on how to make the most informed decision possible.

Look at the research. Here are a few places to start.

• Largest-Ever Study Shows Silicone Breast Implants Associated With Rare Diseases
• “What You Need to Know About Breast Implants” – National Center for Health Research
• Are My Breast Implants Causing My Health Problems? – National Women’s Health Network
• Women with silicone breast implants and unexplained systemic symptoms: a descriptive cohort study

All breast implants break, eventually. An FDA study in the year 2000 found that, of 344 women with a total of 687 implants, 378 of them, or 55 percent, had ruptured. A ruptured implant can cause pain, swelling, and infection.

Know the risks. The FDA lists the following as possible health risks associated with all breast implants:

• Additional surgeries
• Breast implant-associated-anaplastic large cell lymphoma
• Capsular contracture (scar tissue that squeezes the implant)
• Breast pain
• Rupture (tears or holes in the shell) and a deflated implant
• Silent (without symptoms) rupture
• Infection

Talk to your doctor. As with any major, potentially health-changing procedure, a conversation with your doctor to see what he or she knows and recommends is warranted.

Sources:

1. F.D.A. Won’t Ban Sales of Textured Breast Implants Linked to Cancer — The New York Times
2. 5 Things to Know About Breast Implants — FDA
3. Prevalence of rupture of silicone gel breast implants revealed on MR imaging in a population of women in Birmingham, Alabama — American Journal of Roentgenology
4. FDA issues warning letters to two breast implant manufacturers for failure to comply with post-approval study requirements — FDA
5. Doctors, patients warn about cancer linked to textured breast implants — Today