The Truth About Implants

Terry Diaz is sorry she ever got breast implants.

She had them placed in 2006 due to changes in her breasts after nursing three sons, and her surgeon told her they were safe saline implants that would last a lifetime without side effects, except for potential rupture if she was hit hard in the chest.

Two months later, Diaz began having migraines and unexplained weight gain — and that was just the start of her problems.

“Breast implant illness has cost me everything,” she told a Food and Drug Administration (FDA) public advisory committee that heard testimony in March about the dangers of breast implants and considered how to regulate the industry so that women are better protected. In addition to patients, surgeons and implant manufacturers testified.

Diaz described being “bedridden and waiting to die” and said she couldn’t climb stairs after she developed a group of autoimmune symptoms that many patients refer to as breast implant illness. “l had to close my thriving business, and I’m in the process of being accepted into Chapter 13 and home loan modification, but still may lose my home. I can no longer afford health insurance or medical care. Today, I’m no longer bedridden and about 85% better, and the only medical procedure I had was explantation of my implants. I lost 10 years of my life due to ‘safe’ implants.”

Diaz was one of many who gave emotional testimony during the two-day hearing, including others with breast implant illness and some who said their implants gave them a new kind of cancer called breast implant-associated anaplastic large cell lymphoma (BIA-ALCL). The patients called for better informed consent for women considering implants, and some asked that the type of implant most associated with these illnesses — which has a textured surface — be taken off the U.S. market.

While the FDA declined to ban any implants, it issued a call July 24 for implant maker Allergan to voluntarily recall specific models of textured implants associated with cases of the cancer, as well as two types of tissue expanders.

“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 Dr. Amy Abernethy, the FDA’s principal deputy commissioner.

As of July 24, the FDA had records of 573 cases of BIA-ALCL and 33 patient deaths from it across the globe; of these cases, 481 are associated with Allergan implants.

“FDA analysis demonstrates that the risk of BIA-ALCL with Allergan BIOCELL textured implants is approximately six times the risk of BIA-ALCL with textured implants from other manufacturers marketing in the U.S., and continued distribution of Allergan’s BIOCELL textured breast products/implants would likely cause serious, adverse health consequences and potentially death from BIA-ALCL,” the FDA wrote in a safety communication statement.

Allergan responded to the FDA’s request and has notified the agency that it is issuing a worldwide recall of its BIOCELL textured breast implant products, including: Natrelle Saline-Filled breast implants, Natrelle Silicone-Filled breast implants, Natrelle Inspira Silicone-Filled breast implants and Natrelle 410 Highly Cohesive Anatomically Shaped Silicone-Filled breast implants. The recall also includes tissue expanders used by patients prior to breast augmentation or reconstruc- tion, including: Natrelle 133 Plus Tissue Expander and Natrelle 133 Tissue Expander with Suture Tabs.

In its safety communication statement to patients who have or are considering breast implants — as well as their health care professionals — the FDA outlined the known risks of implants and what patients should know when checking for symptoms of BIA-ALCL, such as swelling and pain in their breasts. “The FDA does not recommend removal (of implants) for patients without symptoms due to potential risks, but we provide helpful information for patients and providers to consider when discussing next steps,” said Dr. Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health.

In the spring, prior to the FDA’s request for the voluntary recall, Canada, France and the Netherlands banned some textured implants as a precaution.

A PLEDGE TO INFORM

At its March hearing, the FDA promised to further study the issue of breast implant dangers while making sure that women who plan to get implants are aware of these concerns.

In a statement, the FDA pledged to better inform women and their doctors that the risk of BIA-ALCL rises when textured implants are used and that there seems to be an autoimmune syndrome tied to implants in general. The agency may call for a boxed warning and patient decision checklist to be included with product labeling and will seek to incorporate ingredient lists into implant labels, it said in the statement by Abernethy and Shuren.

The FDA also said it will continue to inform health care providers through a letter about BIA-ALCL and other breast implant risks and will educate pathologists about when to test for the cancer.

The agency plans to publicly share reports made about cases of BIA-ALCL and breast implant illness. Manufacturers used to report medical problems associated with their implants in summary form but now will file individual reports in the Manufacturer and User Facility Device Experience (MAUDE) database, where past data summarized in reports will also be made available.

Finally, the FDA will partner with registries such as PROFILE, which collects data on patients with BIA-ALCL, and the National Breast Implant Registry, which collects data on the safety and performance of implants. Both are run by the Plastic Surgery Foundation. The agency has called on organizers of such registries to encourage more health care providers to participate and contribute information about patient health history, as well as to make the data more public and transparent.

During the hearing, the committee also agreed that more research must be done regarding breast implants’ role in the development of cancer and autoimmune conditions. Dr. Josef Zundorf of the German Federal Institute for Drugs and Medical Devices testified that an international consortium will prepare research proposals on these topics to be considered in the second half of this year.

TWO KINDS OF ILLNESS

First identified about 20 years ago, BIA-ALCL is a rare type of non-Hodgkin lymphoma that arises specifically in women with implants. The FDA first warned women about BIA-ALCL in 2011.

Breast implant illness, meanwhile, involves a constellation of autoimmune issues that can include chronic fatigue, fevers, brain fog and joint pain. Either can affect women who get implants after mastectomy due to breast cancer or a predisposition to the disease.

“Four years ago, I was diagnosed with BIA-ALCL, stage 4, from six-year-old implants, and life as I knew it ceased to exist,” Terri McGregor, of Ontario, Canada, said at the meeting. McGregor said she was treated with chemotherapy, the targeted drug Adcetris (brentuximab vedotin) and a stem cell transplant — which gave her another type of cancer. “The isolation and betrayal

of our cancer is compounded by the dismissive PR campaign of industry. They stayed silent, and when our existence could no longer be denied, we were merely portrayed as anomalies.”

Textured implants, as opposed to uniformly smooth ones, have been associated with BIA-ALCL, although in some cases the type used is unknown. The disease can arise from implants filled with either saline or silicone, according to the American Society for Aesthetic Plastic Surgery.

The chances that a woman with a breast implant will develop BIA-ALCL are between 1 in 3,000 and 1 in 30,000, and the disease typically occurs about a decade after implant, said experts who testified.

There are several theories about what causes the cancer, said Raina Dauria of implant manufacturer Mentor. One is that the increased surface area on textured implants provides a foothold for bacteria introduced during surgery, which can result in long-term inflammation and eventually disease. Another theory blames particulates in the breast capsule — tissue that forms around an implant in about half of women who use them — or free silicone particles on implant surfaces. Experts testified that some women may be genetically susceptible to BIA-ALCL but added that more research is needed.

Representatives of breast implant manufacturers called BIA-ALCL a slow-growing T-cell cancer and noted that it’s usually curable through removal of implants and any affected surrounding tissue. When health insurance doesn’t cover BIA-ALCL-related expenses, “we’ve committed internal resources to assist surgeons for patients in these circumstances,” Brown said. “We give financial assistance for evaluation and any treatment associated with BIA-ALCL.”

A patient, however, accused the representatives of trivializing what she called a “manmade cancer.”

Jennifer Cook of Georgia, who received a diagnosis of BIA-ALCL in 2017, said that surgeons should be required to provide informed consent about the risk of the disease. Cook said she received her implants as part of a clinical trial and signed a consent form stating that there was no established scientific evidence linking them with cancer. Over many years, she said, no one informed her that a risk had been established, and she found out only by watching a play on the topic at the middle school where she taught.

“I was shocked and thought I would need to reprimand the students for making false statements, and then I learned the horrifying truth,” Cook said. “Shortly thereafter, I recognized that I had symptoms. I was blindsided. I was deceived, and I don’t want anyone else to go through that.”

Breast implant illness, meanwhile, seems to occur more often in women who have a personal or family history of autoimmune conditions, experts said, suggesting that more research is needed and that these women should be warned before getting implants. One expert said that this group should opt against implants.

Patients called on authorities to officially name the condition, formally tie it to breast implants and stop dismissing women who complain of symptoms. Although the syndrome is not recognized by many doctors or health insurers, Facebook has more than 170 groups and communities devoted to it; the largest includes more than 70,000 members, according to Jamee Cook, of Breast Implant Victim Advocacy.

Some members of the public, including some surgeons and a breast cancer survivor who has them, testified in favor of implants, saying that they are largely safe and give a meaningful psychological boost to women who have deformities or have undergone mastectomy and seek augmentation.

Patients, however, told horror stories of declining health, hospitalizations and lost jobs. Some suggested that the implants that sickened them also left their children — conceived or breastfed while the implants were in place — with lasting health problems.

SEEKING SAFEGUARDS

The patients who testified said that surgeons should be more upfront about potential side effects and the high likelihood that reoperation — an expense that may not be covered by health insurance — will be needed over time due to leakage, rupture, capsular contracture (a sometimes painful complication that can occur in the tissue that forms around an implant) or other health problems. Some surgeons urged the FDA to authorize high-resolution ultra- sound as a cheaper, more reliable way of checking for breast implant rupture than the only modality currently approved — MRI, which can cost women $2,600 out of pocket and is therefore inaccessible to many. They cited studies supporting the accuracy and feasibility of ultrasound for this purpose.

Patient requests also included research about the safety of implants during breastfeeding, an FDA requirement that manufacturers reveal the ingredients in their implants and the removal of textured models from the market.

In 2018, less than 10% of the breast implants used in the United States were textured, and the rest were smooth, the FDA said in its statement. Stephanie Manson Brown, a representative of implant manufacturer Allergan, noted that the opposite is true outside the United States.

Brown stated that textured implants have a role to play because they are anatomically shaped, stay in place better than smooth models (which are round) and may be associated with a lower rate of capsular contracture. One panelist questioned whether even smooth implants provide a safe option, since many surgeons — in a practice not approved by the FDA — wrap mesh around the implants to better keep them in place.

Manufacturers also discussed their efforts to track patients and their outcomes in FDA-mandated company registries. Registries have been required since 2006, when silicone gel implants were put back on the market after being removed in 1992 due to concerns that they were tied to illnesses.

Two companies, Mentor and Sientra, recently received letters from the FDA citing them for insufficient follow-up with users of their products. In addition, panelists complained that the studies the companies submitted to the FDA have different formats and timelines and can’t be compared.

Manufacturers’ representatives said that it’s challenging to collect this information because many women choose to leave the studies. Some patients countered that they had remained engaged in follow-up studies — until manufacturers canceled them.

“These post-approval studies were required by the FDA, but they’ve been flawed and incomplete and not reliable,” Jamee Cook said. “There’s been a failure to complete studies. Some women got lymphoma that would have been documented (if the studies had continued). Some women were told a study stopped or that the doctor had dropped out, or women were dropped after reporting symptoms. We’re missing data because of this.”

A national registry should track issues including patient and family health history and prior use of breast implants, said Dr. Binita Ashar of the Center for Diseases and Radiological Health. Zundorf said it would be helpful to develop a national system for classifying the surface texture of implants, making it possible to compare the findings of registries tracking BIA-ALCL across the world.