Key Points of Textured Breast Implant Recall
• On July 24, 2019, the FDA asked Allergan to recall its textured breast implants due to the risk of breast implant–associated anaplastic large-cell lymphoma (BIA-ALCL), a rare cancer that has affected over 500 women globally.
• Breast implants have an outer shell that can be either smooth or textured. Textured implants, with a rougher surface, have been specifically associated with this cancer.
• The textured implants affected by Allergan's recall account for less than 5% of all implants sold in the U.S.
• The FDA doesn't suggest that consumers remove their implants if they have no symptoms or problems with them.
• If you have implants, check your implant ID card to determine the type. Your surgeon should also have this info in your patient record.
• Learn about the risks and obtain crucial safety information. Talk to your surgeon if you have any queries, symptoms or concerns.
Allergan, one of the major producers of textured breast implants, declared on Wednesday that it will recall many of these products globally. This action was in response to the U.S. Food and Drug Administration's (FDA) request for the company to recall its Biocell textured implants due to the risk of breast implant-associated anaplastic large-cell lymphoma (BIA-ALCL), a rare cancer that has affected numerous women. The recall encompasses four textured implants under the Natrelle brand (saline-filled implants, silicone-filled implants, Inspira silicone-filled implants and 410 silicone-filled implants) as well as two textured tissue expanders (Natrelle 133 Plus Tissue Expander and Natrelle 133 Tissue Expander with Suture Tabs). Textured breast implants have a more adherent surface to keep the implant in position, contrary to smooth implants. The texture of the implant is specifically linked to this cancer.
Sharon Rovira was 43 when she received Allergan textured breast implants and 54 when diagnosed with cancer. Her chest wasn't a source of insecurity or embarrassment for most of her life. But after giving birth to and breastfeeding four children, she decided it was time for a bit of rejuvenation. She made an appointment with a plastic surgeon and shortly after, received two textured implants.
Approximately 12 years after her surgery, she noticed that her right breast was starting to accumulate fluid around the implant. Her doctor prescribed antibiotics, which eliminated the fluid; but two years later, the same breast became encapsulated, hardening when touched. Then persistent fatigue and a chronic cough emerged, and Sharon grew increasingly ill to the extent that she needed to be hospitalized. The doctors biopsied tumors found beneath her breasts and in her arm and informed her that she had Stage 3 lymphoma as a consequence of her implants. During the subsequent months, Sharon underwent eight rounds of chemotherapy, nine blood transfusions and several surgeries, leaving her asymmetrical and with a large scar around her torso. "I'll never be the same again," she says. "If I had been informed that this could happen to me or that it was even a possibility, I wouldn't have gone through with it." As of early 2024, she is in remission because, like the other 540 women worldwide who have survived BIA-ALCL, she received top-notch medical care and detected the cancer relatively early. However, 33 women haven't been so fortunate... and this preventable and treatable disease ultimately led to their deaths.
For patients like Sharon (who filed a lawsuit against Allergan last year), the pharmaceutical company's decision to recall textured breast implants brought relief. After years of speculation and research, the World Health Organization confirmed a connection between textured breast implants and ALCL in 2016. "Over the years, our comprehension of this disease has significantly advanced," says Dr. Mark Jewell, a plastic surgeon in Eugene, Oregon. "It's believed to be a form of bacterial contamination on the implant's surface during surgery, which causes chronic inflammation, a change in T-cell lymphocytes and ultimately, this breast-associated ALCL."
Related: Breast Implant Safety: FDA Announces New Policies, Won't Ban Textured Implants
"ALCL seems to have multiple contributing factors," adds Dr. Melinda Haws, a Nashville plastic surgeon. "We know there are genetic elements. We know there appear to be bacterial biofilms present in these patients. We don't have all the answers yet, but we know it occurs with textured implants – the majority of which are Allergan Biocell."
As awareness of BIA-ALCL has increased, several major markets have abandoned this implant type, and doctors worldwide have chosen smooth alternatives. According to the FDA, Allergan's textured implants make up less than 5% of all implants sold in the U.S. They were removed from the European market last December after a recall request from French authorities; from the Canadian market in May; and from the Australian market earlier this month when the government suspended sales of such implants from Allergan and Johnson & Johnson, among other manufacturers.
"What makes this an intriguing case is that you actually witness the FDA taking proactive action, which doesn't occur that often," says Michael Brady Lynch, an attorney based in Orlando, Florida, specializing in pharmaceutical and medical-device litigation. "But what's unfortunate is that Allergan could have done this on its own. It could have removed these products from the market months, if not years ago, in the interest of patient safety. But it waited until the FDA compelled it."
It's also crucial to recognize the factors, apart from the implants themselves, that are thought to contribute to the cancer.
The occurrence of BIA-ALCL can't always be prevented, but Dr. Haws believes surgeons can take precautions to ensure their operations are as clean and safe as possible. "Everything we do as plastic surgeons is influenced by technique," the Nashville doctor states. "While the breast ducts mean there's always an external path into the breast for bacteria, maintaining a meticulous surgical field minimizes any chance of bacterial contamination during surgery. Again, we don't have all the answers, but technique is always important."
Related: 4 Changes We Want to See Coming Out of the FDA’s Breast Implant Safety Hearings
Dr. Jewell agrees. "Many of us have reported outcome data with textured implants over the years, demonstrating that they could be used safely," he says, referring to a study published in the journal Plastic and Reconstructive Surgery just this month. "Basically, it was 22,000 patients, followed up for 14 years. All of us used similar techniques, and we had no BIA-ALCL. Texture has certain benefits that allow it to be useful in breast surgery, but at the same time, it can get contaminated with bacteria. As long as you take measures to reduce that risk, things seem to work well."
Members of the plastic-surgery community are also concerned that Allergan's textured-implant recall will unjustifiably scare many women. While the FDA has requested that these implants no longer be available, the agency has notably not issued an advisory warning for patients who have no symptoms or reason to believe there are any issues with their implants. Dr. Hawes, who has 12-year-old Biocell implants in her own breasts, declares that "with the risk of ALCL at 1:3200, I wouldn't have my implants removed, any more than I would have a prophylactic mastectomy for a risk of breast cancer, which is 1:8." In other words, unless you're experiencing complications, there's no need to panic.
"If you do have swelling or pain in one of your breasts, definitely go see a plastic surgeon and get it assessed, but it's very straightforward to deal with," says Dr. Jewell. "At the end of the day, I'm here for my patients, not to defend textured implants. If a patient is worried about them or wants them replaced, it's a personal choice."
But above all, Wednesday's recall announcement is just another reason for open communication between patients and their surgeons, whether about the signs and symptoms of BIA-ACLC or simply about the importance of annual mammograms and monitoring their breasts for changes. "I hope this ban makes all women pay more attention to what's happening with their breasts," says Dr. Haws, "whether they have implants or not."
