What’s the relationship between breast implants and cancer risk? The Food and Drug Administration (FDA) recently released a recall of a certain type of breast implant with a textured surface—BIOCELL, manufactured by Allergan. The FDA acted after reports of 573 cases of cancer and 33 deaths worldwide from a rare lymphoma were associated with these breast implants. In all, 481 of those cancer cases involve patients who, according to the FDA release, "are reported to have Allergan breast implants at the time of diagnosis."
Known as breast implant-associated anaplastic large cell lymphoma (BIA-ALCL), this cancer is a rare T-cell type of non-Hodgkin's lymphoma that is not breast cancer, but rather a cancer of the immune system. The news has many women who have had breast reconstruction after a mastectomy or cosmetic breast augmentation concerned about their health.
“Although the overall incidence of BIA-ALCL appears to be relatively low, once the evidence indicated that a specific manufacturer’s product appeared to be directly linked to significant patient harm, including death, the FDA took action to alert the firm to new evidence indicating a recall is warranted to protect women’s health,” said FDA principal deputy commissioner Amy Abernethy, MD, PhD, in a statement.
While the recall is a step in the right direction, the FDA reports that incidence of this cancer has been rising, with an increase of 116 new cases and 24 deaths so far this year alone. And that trend may continue because this cancer can develop many years after implant placement.
“Textured implants became much more commonly used about a decade ago when shaped implants came on the market,” explains Tomer Avraham, MD, a Yale Medicine plastic surgeon and expert in breast reconstruction. The textured surface helps prevent slippage. “As women have these implants over a longer period of time, the incidence may continue to rise. When I first came to know about this issue early this decade, it was a 1 in 500,000 occurrence—so, not much worse than being struck by lightning, not something worth worrying about. More recently, numbers like 1 in 30,000 have been published. Some centers have begun unofficially reporting even higher rates.”
Allergan has notified the FDA that it is now recalling these implants worldwide, so this product will no longer be in use. Also being recalled are the company’s tissue expanders, sometimes used in a first-stage operation to make room in the chest wall for the implant.
The FDA’s recall announcement can be traced, in part, to a decade’s worth of data collected from the Plastic Surgery Foundation. Yale Medicine’s John Persing, MD, chief of Plastic & Reconstructive Surgery, served as the foundation’s president and was part of an effort to develop this registry to track cases of lymphoma associated with breast implant recipients.
“It’s very gratifying to see how this effort and all the data that’s been gathered are having a positive impact on clinical practice and improving patient care,” says Dr. Persing.
What should you do if you have breast implants?
At this time, the FDA does not recommend removal of these or other types of breast implants for patients who have no symptoms due to the low risk of developing BIA-ALCL.
So, the FDA’s recent announcement should not change anything for the overwhelming majority of patients who have smooth-surfaced implants or textured implants by other manufacturers, says Henry Hsia, MD, a Yale Medicine plastic surgeon.
Dr. Hsia strongly advises, though, that no matter what kind of implant a person has, it’s important to be “breast aware” and report any persistent symptoms to your doctor. “Anyone with pain or discomfort or other concerning changes in her breasts should get in touch with her plastic surgeon,” he says. Changes include swelling, lumps, or pain—all are symptoms of BIA-ALCL to look out for.
“For years, all of our breast reconstruction patients at Yale Medicine have been counseled extensively when they come for their initial preoperative consultation visit about the BIA-ALCL risks (along with the general risks of implants such as infection), and the FDA announcement should hopefully only reinforce the counsel and advice that they originally received from their providers,” Dr. Hsia says.
Women with breast implants that are not part of the recall may wonder if there is any change to advice they’ve been given about getting mammograms. According to Anees Chagpar, MD, a Yale Medicine surgical breast oncologist, women who’ve had mastectomies and have implants for reconstruction do not need routine mammograms, as there should be minimal (if any) breast tissue remaining. Recurrences can still happen, however, and would show up like a pimple under the skin of the reconstructed breast. If patients have any concerns about the possibility of a recurrence, they should contact their doctor. “Patients who have implants for cosmetic reasons should follow the same breast cancer screening guidelines, including mammography, as anyone else,” she says, “since they still have breast tissue.”
Yale Medicine radiologists recommend that women at average risk for breast cancer who are ages 40 and older receive annual mammograms. If you are at increased risk for breast cancer due to family history or have had chest radiation for other conditions during your lifetime, talk to your health care provider about having a breast cancer screening test before age 40.
Here are some tips to keep in mind if you have implants or are considering them:
Know your implants. The implant-associated lymphoma cases reported to the FDA occurred more often in women who have textured versus smooth implants, particularly from the BIOCELL textured implants. Before getting breast implants, the FDA recommends that your health care provider talk to you about the benefits and risks of different types of implants.
Keep your serial number. Keep the manufacturer serial number information provided by your plastic surgeon at the time of reconstruction or augmentation, including the device manufacturer name, unique device identifier, and implant model name. That way if there’s ever a recall or health concern surrounding the type of implant you have, you can make an appointment with your doctor to discuss your options, if necessary.
Pay attention to symptoms. Generally speaking, don’t ignore unusual health symptoms of any kind. Make a doctor’s appointment and discuss how you’re feeling with your health care provider. Regarding this type of lymphoma specifically, the symptoms most women report include persistent swelling or pain near the breast implant, according to the FDA. Some women detect lumps, masses, excess fluid, or capsular contracture (thick scar tissue around the implant). See your doctor if you have discomfort after implantation, which should be evaluated through imaging and possibly biopsied to rule out rare incidences of BIA-ALCL.
Follow FDA advice. If your physician deems that there is BIA-ALCL, you should undergo implant removal as well as removal of the surrounding scar capsule. It may be possible to replace the device with one not associated with BIA-ALCL.
If you have questions about breast implants, contact our plastic surgeons at (203) 785-2571. For questions about the recall, contact the FDA at (800) 638-2041.