comscoreSpecial Report: Breast Implant Illness and BIA-ALCL

Special Report: Breast Implant Illness and BIA-ALCL

In this special report, we have compiled the most important information you need to know about breast implant illness (BII) and breast implant-associated anaplastic large cell lymphoma (BIA-ALCL).

2019 was a watershed year for awareness about certain risks associated with breast implants: breast implant illness (BII) and breast implant-associated anaplastic large cell lymphoma (BIA-ALCL). In this Special Report from, we have compiled the most important information you need to know about BII and BIA-ALCL, from risk factors, symptoms, and treatment, to the work of patients and advocates that led to product recalls and new safety recommendations from the FDA.

Robyn Towt was an active, energetic mom of two teenaged boys when she was diagnosed with breast cancer at the age of 44 and had a double mastectomy. At the time of her diagnosis, in 2017, she walked several miles a day for exercise and loved to go waterskiing with her sons near their home in Arizona.

She opted for breast reconstruction with smooth-surfaced, silicone gel-filled implants, but as soon as she woke up from that surgery, she says, “I knew something wasn’t right.” In the days and weeks that followed, she developed mysterious, debilitating symptoms — migraines, extreme fatigue, insomnia, rashes, dizziness, hair loss, breathing problems, and burning pain in her chest, neck, and shoulder.

“It got to the point where I couldn’t function and I was pretty much confined to lying on my couch,” says Towt. “I’ve had cancer three times in my life, and those breast implants [made me feel] worse than all of my cancers put together.” After learning from another woman in an online breast cancer support group that a reaction to her breast implants could be the cause of her symptoms, Towt decided to have her implants removed. She’d had the implants for 4 months, and all of her symptoms disappeared within a week of removing the implants.

“I was shocked by how much better I felt once the implants were out,” she says. “And I wanted to tell the world because … if this happened to me, how many other women who’ve had breast cancer is this happening to?”


Emerging risks of breast implants

Doctors often present breast reconstruction surgery as an important step that can help women move forward and feel more comfortable with their appearance after a mastectomy. And for many, it does — more than 60% of women choose to have some kind of reconstruction after mastectomy, and most report they are satisfied with the results. 1

Like any surgery, breast reconstruction procedures carry risks, and reconstruction with implants — the most common type of breast reconstruction — carries risks that some women who’ve undergone the procedure say they weren’t adequately warned about.

The FDA has long advised women considering breast implants that they shouldn’t expect them to last a lifetime, and should assume they’ll need additional surgeries at some point because of well-known complications like capsular contracture (tightening of the capsule of scar tissue around the implant) and implant rupture. But there are also two serious risks that recently started to receive more attention from health authorities, doctors, and the media because of new research and because women who were affected are speaking out.

One is the condition Towt developed — breast implant illness (BII) — a cluster of symptoms such as fatigue, memory loss, and joint pain that can occur after getting breast implants and that frequently improve after the removal of the implants (explantation). Many of the symptoms of BII are the same as those of autoimmune and connective tissue disorders, such as lupus and rheumatoid arthritis. However, only some people who have BII get diagnosed with a specific autoimmune or connective tissue disorder. BII isn’t well understood and isn’t officially recognized as a medical condition, but some experts say it’s likely to be related to an autoimmune reaction to the implants.

The other serious risk is a rare form of T-cell lymphoma (cancer of the immune system) called breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) that develops in the scar tissue and fluid surrounding an implant. So far, all the confirmed cases of BIA-ALCL have been in women who had breast implants with a textured surface or whose implant surface type was not known. BIA-ALCL is curable in most patients if it’s diagnosed early and treated appropriately, but at least 33 women have died from the illness as of July 2019. 2 Some patient activists call BIA-ALCL a “man-made cancer” because it’s linked to a specific medical device and was identified for the first time in 1997.

“Breast implant safety has become a very heated topic with a lot of unknowns and a lot at stake,” says Sophie Bartsich, M.D., FACS, a plastic surgeon and assistant clinical professor of surgery at NewYork-Presbyterian/Weill Cornell Medical Center. “It is good that there is more discussion happening, because people need to know about BII and BIA-ALCL, the differences between them, and the risk factors for each condition. Right now there is a lot of confusion and fear.”


Breast implant safety: A decades-long debate

Since the 1960s, implants have been used to restore the look and shape of the breasts after a mastectomy (reconstruction) and for cosmetic breast enlargement (augmentation). They’ve grown in popularity in recent years despite the fact that for decades there have been heated debates over their safety. In 2018, more than 101,000 breast reconstruction procedures were performed in the U.S., and 82% of them used implants. In addition, more than 313,000 breast implant surgeries were performed for cosmetic augmentation. 3

Some breast cancer patients — more than 18,000 in 2018 — chose reconstruction using their own tissue (autologous reconstruction) rather than implants. 3 Women who opt for autologous surgery tend to have higher long-term satisfaction with their reconstruction. But autologous surgery is less common because fewer plastic surgeons have experience with it, it’s a more complex surgery with a longer recovery time, and some women aren’t candidates, usually because they don’t have enough extra tissue.

Plastic surgeons are supposed to carefully go over the risks and benefits of a reconstruction procedure, and the alternative treatment options, with a patient before the surgery takes place. Recently, a number of women who got breast reconstruction with implants have raised concerns about whether they received enough information from their doctors about newly emerging risks before they agreed to the surgery.

Those who had breast cancer and later found out that their implants triggered a second illness say that the news can be devastating and can cause them to lose faith in the medical system.

“It was a shock, and it is much harder to deal with than the original [breast cancer] diagnosis,” says Lory D’Addario, from Connecticut, who developed BIA-ALCL in 2017, 2 years after she had a double mastectomy and breast reconstruction. “You realize that this is something you put in your body to help you get your life back to normal only to find out you’ve developed a second cancer from an implant.”

Additionally, because BIA-ALCL is a relatively rare condition and both BIA-ALCL and BII are not always recognized by doctors, some women who developed BII or BIA-ALCL had difficulty getting the correct diagnosis and proper care.

Roxane Vermeland, from Illinois, had an experience that she has since found is not unusual among women who have serious health problems related to their implants. She learned that her symptoms could be linked to BIA-ALCL not from her doctors, but by doing her own research online.

In 2018, she had significant swelling and pain around her left implant. She read that those are potential symptoms of BIA-ALCL on Facebook and asked her plastic surgeon if she could get tested for it. “He said to me, BIA-ALCL is so rare that you don’t need to be tested,” Vermeland recalls. “I had to insist and to advocate for myself.” The test came back positive.


Main risk factors for BIA-ALCL and breast implant illness

Breast implants have a silicone outer shell that can be either smooth or textured, and the main known risk factor for BIA-ALCL is having a textured implant.

The risk factors for BII aren’t as clear but are likely to include having a personal or family history of autoimmune conditions, allergies, and conditions such as irritable bowel syndrome, migraines, chronic fatigue, or fibromyalgia.

Both smooth and textured implants are filled with either silicone gel or saline (salt water). Silicone gel-filled implants are the most common — in 2018, 88% of breast implants sold in the U.S. were silicone gel-filled. 3 Much of the attention and research related to the question of whether breast implants can cause autoimmune symptoms or other health problems has centered on silicone gel-filled implants in particular.

While more research is needed on whether implant fill type is linked to a higher risk of BII or BIA-ALCL, it’s important to know that both conditions have occurred in women who got silicone gel-filled or saline-filled implants for reconstruction or for cosmetic augmentation. A history of breast cancer also doesn’t, in itself, appear to increase the risk for BII or BIA-ALCL.

Learn more about each condition, including specific risk factors and possible causes, number of cases, diagnosis, treatment, and more:

Note: There is some confusion over the terms breast implant illness (BII) and breast implant-associated anaplastic large cell lymphoma (BIA-ALCL). BII is not BIA-ALCL. They are completely separate conditions.


The FDA takes a new look at breast implant safety

Because of new data that showed the majority of cases of BIA-ALCL and deaths due to BIA-ALCL are linked with textured breast implants manufactured by Allergan, the FDA requested a global recall of Allergan Biocell textured implants and tissue expanders in July 2019. By that time, 38 other countries had already banned Allergan Biocell implants.

The recall was perhaps the biggest news in years on the regulation of breast implants, and the FDA has said that it intends to do more going forward to better understand BIA-ALCL and BII and communicate with the public and healthcare professionals about breast implant risks.

“Something is shifting. Compared to a couple of years ago, the FDA is being more open-minded about addressing implant safety,” says Diana Zuckerman, Ph.D., president of the National Center for Health Research and a researcher who has studied breast implant safety issues. “For decades, the FDA insisted there was no evidence that breast implants caused any systemic illness. Then the clear evidence on BIA-ALCL had a big impact. And I think the FDA has become more concerned about BII because more plastic surgeons are publicly saying that they believe BII is a real illness and that they’ve seen their patients get better after having their implants removed.”

These are some of the other steps the FDA took recently:

  • Holding a public meeting about the risks of breast implants. In March 2019, the FDA’s General and Plastic Surgery Devices Panel held a 2-day public meeting to hear presentations from researchers, doctors, advocates, patients, and industry representatives about BIA-ALCL, BII, using registries to collect data on breast implants, and other topics related to improving breast implant safety. More than 40 breast implant recipients spoke at the meeting, many of them sharing stories of how implant-related illnesses impacted their lives. They also asked the FDA to take action to remove potentially unsafe devices from the market, hold implant makers accountable for failing to conduct adequate safety studies, and require that all patients considering implant surgery are given the information they need about risks to make an informed decision.  (Links to the webcasts of the meeting can be found here and you can also read transcripts from the first day and the second day of the meeting.)

  • Starting to acknowledge BII and potential safety issues with silicone more than in the past . In the spring of 2019, the FDA updated the information about risks and complications of breast implants on its website to include an acknowledgement that some patients report experiencing breast implant illness (BII) symptoms and released a statement saying that they’re working on better characterizing the condition and its risk factors. The agency also announced that it is undertaking new efforts to evaluate the safety of specific materials in medical devices, including silicone. “We believe the current evidence, although limited, suggests some individuals may be predisposed to develop an immune/inflammatory reaction when exposed to select materials [in implantable or insertable medical devices],” the agency said.

  • Sending warning letters to implant manufacturers . In March 2019, the FDA sent warning letters to two breast implant manufacturers, Mentor and Sientra, because the companies had not conducted the long-term safety studies that were required as part of the implants’ FDA approval. The FDA said that the manufacturers had failed to enroll enough women, follow them annually for 10 years, and collect enough data on specific complications. The warnings applied to Sientra Opus silicone gel-filled breast implants and Mentor MemoryShape and MemoryGel silicone gel-filled breast implants. The implants could be taken off the market if the research isn’t properly done.

  • Releasing previously hidden data on adverse events related to breast implants.
    In June 2019, the FDA published online millions of reports of malfunctions, injuries, and other problems with medical devices (including tens of thousands related to breast implants, such as cases of implant rupture) that were not released to the public from 1999 to 2019. During that time, the FDA had allowed some manufacturers to submit reports that only FDA employees could see and that weren’t included in the Manufacturer and User Facility Device Experience (MAUDE) database (which the public can access).


How we got here: a brief history of breast implant regulation

To understand why there are still unresolved questions about the safety of breast implants nearly 60 years after they were first sold in the U.S., it helps to know a little history.

1960s-1980s: Little research and regulation
When breast implants were first introduced in the early 1960s, there was little-to-no research on their safety and no requirement that medical devices go through an approval process. The FDA didn’t have the authority to regulate medical devices until 1976, and the implants that were already on the market were “grandfathered” in.

Meanwhile, reports linking silicone gel-filled breast implants and autoimmune symptoms began to appear in medical literature in the 1970s and 1980s.

1980s-1990s: Lawsuits and FDA ban on silicone gel-filled implants
Thousands of women won lawsuits against Dow Corning and other implant manufacturers beginning in the 1980s and throughout the 1990s, based on claims that they had developed health problems because they had silicone gel-filled breast implants.

In 1992, the FDA restricted the use of silicone gel-filled breast implants in response to public concerns about health risks, including cancer, connective tissue diseases, and autoimmune disorders. Saline-filled implants remained on the market, and silicone gel-filled implants could still be used for breast reconstruction, correction of congenital deformities, or replacement of existing implants. Women who received silicone gel-filled implants for these purposes had to be enrolled in clinical trials to collect data about device performance and safety.

Congress asked for a study of the safety of silicone gel-filled breast implants and, in 1999, the Institute of Medicine released a 400-page report prepared by an independent committee of scientists. The committee reviewed the existing literature and concluded that there was no clear link between silicone gel-filled implants and connective tissue disease, autoimmune disease, or cancer.

2000s: FDA reverses silicone implant ban
The FDA lifted the ban on silicone gel-filled implants in 2006, approving silicone gel-filled implants from two manufacturers, Allergan and Mentor (the Allergan Natrelle and the Mentor MemoryGel). Three other silicone gel-filled implants have been approved since then.

2010s: Old concerns re-emerge
In order to have their breast implants approved, Allergan and Mentor were required by the FDA to conduct large studies to monitor long-term safety and risks. The manufacturers were supposed to have researchers follow 40,000 women for 10 years after the implants were approved. More than 40,000 women were enrolled by each company, but by 2011 it became clear that they didn’t do enough to make sure patients continued to participate in the studies, and many were no longer followed by researchers.

“It’s not the data collection that we were hoping for, because it still leaves a lot of questions,” says Frank J. DellaCroce, MD, FACS, plastic surgeon and founding partner of the Center for Restorative Breast Surgery and the St. Charles Surgical Hospital in New Orleans. “The disappointing news is that it isn’t well compiled, a lot of it was self-reported by patients, and a lot of the patients dropped out at between 2 and 7 years.”

In 2019, the FDA sent warning letters to two manufacturers of silicone gel-filled implants, Mentor and Sientra, for failing to comply with the FDA’s study requirements.

Some experts say that currently, there still isn’t enough good-quality research on long-term safety outcomes and on rare health problems linked with breast implants. “What we’re largely missing is studies that are well-designed, long-term (10 years or longer), and that include large numbers of women with breast implants,” Zuckerman says.

Even though there are significant flaws in the data from the large post-approval studies conducted by Allergan and Mentor, it reflects the outcomes of nearly 100,000 patients with breast implants. The size of the database allowed a team of investigators to evaluate the risk of rare adverse outcomes. In September 2018, researchers from the University of Texas MD Anderson Cancer Center in Houston published a study in the Annals of Surgery 4 that looked at the data from the large post-approval studies that started in 2007 and found that compared to women in the general population, women with silicone gel-filled implants were:

  • 8 times more likely to be diagnosed with Sjögren syndrome, an autoimmune disorder characterized by dry eyes and a dry mouth

  • 7 times more likely to be diagnosed with scleroderma, a group of autoimmune diseases that cause the skin and connective tissues to become hard and tighten

  • nearly 6 times more likely to be diagnosed with rheumatoid arthritis

But importantly, while this study showed an association between silicone gel-filled breast implants and an increased risk of certain health conditions, it did not show that implants cause these conditions.

“That slight statistical association [with Sjögren syndrome, scleroderma, and rheumatoid arthritis] has not been seen in very small studies of several hundred or several thousand patients, but it was confirmed by other studies that looked at tens of thousands or 100,000 patients — you see the slight statistical association when you look at large numbers of patients with silicone gel-filled breast implants,” says Mark Clemens, MD, FACS, senior author of the study in the Annals of Surgery and associate professor of plastic surgery at the University of Texas M.D. Anderson Cancer Center. “Now researchers need to study the patients that manifest these symptoms to understand the nature of that association and try to figure out what’s going on,” he says.


Questions about the materials in implants

A key question that needs further investigation is whether some people may be predisposed to having a reaction to the materials in breast implants, causing inflammation and autoimmune problems. While the exact cause of BII and BIA-ALCL isn’t known, some researchers have theorized that an inflammatory reaction could play a role in both conditions.

It’s clear that women who’ve had breast implants with a textured surface have a greater risk of developing BIA-ALCL compared to women who have only ever had implants with a smooth surface. But researchers don’t know why. Some have theorized that the rough surface of textured implants might cause chronic inflammation that can lead to lymphoma. Others have proposed that the rough surface and greater surface area traps more bacteria, creating a biofilm that causes inflammation and leads to lymphoma.

Another issue that needs to be better understood is whether materials from implants that spread into the body or just come into contact with surrounding body tissues cause BII or other health problems in some individuals. Studies have shown that substances from breast implants (such as very small amounts of silicone and platinum) can “bleed” through an intact shell and into the surrounding tissue. Substances from an implant can also spread within the capsule of scar tissue surrounding the implant or to other parts of the body because an implant has ruptured. The longer a breast implant is in place, the more likely it is to rupture. The risk of rupture is very low at first and starts to increase about 4 to 6 years after implantation. 5

Some doctors consider saline-filled implants to be a safer choice for women who are concerned about the potential health risks of breast implants. If a saline-filled implant ruptures or its valve fails, it’s fairly easy to detect the leak because the breast will quickly appear deflated. Also, the saline (salt water) that leaks out will be absorbed by the body.

By comparison, if a silicone gel-filled implant ruptures, the gel leaks out slowly because it’s thicker. It may take a woman much longer to realize that her silicone gel-filled implant has leaked, or she may not realize it at all. And unlike saline, the leaked silicone is not absorbed by the body.

However, it's important to know that all women with breast implants are exposed to silicone to some degree, because both silicone and saline implants have a silicone shell.

Whether the silicone or other chemicals in breast implants can be harmful to health is still controversial. Studies in laboratory animals have shown that the silicone in breast implants can cause immune reactions.

Dr. DellaCroce points out that what we know about the condition capsular contracture (tightening of the capsule of scar tissue around a breast implant) suggests that the body may react to silicone.

“We know that if you have a silicone gel-filled implant that ‘bleeds’ or ruptures, that increases your chances of developing capsular contracture. And we know that capsular contracture is related to inflammation,” he says. “This suggests an inflammatory reaction to silicone exposure may occur.”

It’s also possible that certain individuals are genetically predisposed to having an inflammatory reaction to the materials in breast implants. Scientists are currently investigating genes that may play a role in the development of capsular contracture, BII, and BIA-ALCL.

“Although we don’t have concrete scientific evidence of this yet, I think that we are going to find out that there is a small percentage of people who do not tolerate silicone — they react to it and their bodies just don’t like it,” says Dr. Bartsich. “We need a test to identify who is at risk, and we don’t have that yet.”


Finding community online

With all the controversy and lack of clarity about breast implant risks, it’s no surprise that women who suspect their implants are making them sick have banded together for support. During the past few years, thousands joined online communities related to BII and BIA-ALCL. The largest and most active community, the Breast Implant Illness and Healing by Nicole Facebook group, currently has more than 100,000 members, and there are dozens of other groups.

“Several hundred women arrive each day to our forum with the same story of symptoms, the same loss of health,” said Nicole Daruda, the founder of Breast Implant Illness and Healing by Nicole, in a speech at the March 2019 FDA meeting on implant safety. “We have all been repeatedly told our breast implants were safe or are safe and our symptoms are not from our implants, by both plastic surgeons and by family doctors who are misinformed.”

Women turn to the online communities to find information about their symptoms, possible treatments, and recommendations for helpful doctors. The online groups have also helped to bring together those who want to use their voices for change. Several women we spoke with said that participating in the online communities led them to become activists. Now they’re raising awareness of implant safety issues by working directly with the FDA and plastic surgery societies, appearing in the media, starting online petitions and campaigns, and more.

Christy Avila from San Jose, CA, was diagnosed with stage III breast cancer, had a double mastectomy and reconstruction with implants, and then developed BII and got her implants removed. She spoke about these experiences at the March FDA meeting. After joining other online support groups, she started a Facebook group called Fierce, Flat, Forward for women who’ve had breast cancer and wound up “going flat” (going without reconstruction after a mastectomy) or are considering it. “I’m blown away by how fast the group is growing,” she says. Avila and other “flat” advocates want women to know that they don’t have to choose reconstruction after a mastectomy or when they need a reoperation because they’re having problems with their implants. “I’ve heard from a lot of women who were made to feel like they had to get reconstruction. It's often packaged as just part of breast cancer treatment,” she says.

Zuckerman credits the social media groups and patient activists with pushing the FDA and plastic surgeons to re-examine the safety of implants and with assisting many individual women who felt they had nowhere else to turn.

“I have no doubt that a lot of women who got their implants out and are feeling better now would never have done that if it weren’t for the Facebook groups and websites,” she says. “It’s so unfair that women had to get the information from strangers online instead of their doctors, but it’s also been so helpful to so many women.”

If you’re considering breast implant surgery — or any other kind of medical procedure — your surgeon is supposed to make sure that you understand the risks, benefits, and alternative treatment options so you can make an informed decision. State and federal laws specify some of what is supposed to happen as part of this process, which is known as informed consent.

Ideally, informed consent involves having an open discussion with your surgeon, being able to ask questions, and receiving written information about risks that’s easy to understand. This should take place before you’ve paid a nonrefundable deposit for the procedure. If you decide to move forward with the surgery, you sign an informed consent form, acknowledging that you’ve been given the information you need and that you’re agreeing to the surgery.

However, not all plastic surgeons handle informed consent in the same way. Some devote more time to discussing potential risks with patients and give patients more information about risks than others. Sometimes the risk of conditions like BIA-ALCL and BII doesn’t get discussed at all.

When Lory D’Addario got reconstruction with Mentor textured implants in 2015, the link between breast implants and BIA-ALCL had already been identified. The FDA, the National Comprehensive Cancer Network, and the American Society of Plastic Surgeons had been publishing information about BIA-ALCL for a few years. However, D’Addario says her plastic surgeon did not mention this risk.

“BIA-ALCL was never brought up before my surgery. If I had known it was a possibility, I know I would have said ‘forget it.’ I never would have taken a chance and gotten implants,” she says.

Many other women have reported that they felt their surgeons downplayed the risks of breast implants and that they weren’t given written information that described the risks in an up-to-date and easy-to-understand way.

“We are told very briefly about the inherent risks to surgery, not to the implants,” said Holly Davis, from Charleston, SC, at the March FDA meeting. She had a prophylactic mastectomy and reconstruction with implants and then had BII.

After the March meeting, the Breast Implant Working Group, a team that includes Zuckerman, two plastic surgeons, and three patient advocates, drafted a Breast Implant Patient Informed Consent Checklist and Black Box Warning. They asked the FDA to require plastic surgeons to go over a document similar to this one with all patients who are considering breast implant surgery, including those who are considering surgeries to exchange their current implants with new ones. In drafting the document, the working group aimed to provide balanced information about both rare and more common risks associated with implants, some of which may be missing from the informed consent and patient information materials that plastic surgeons currently use.

In October 2019, the FDA responded by releasing a draft of recommendations to breast implant manufacturers for new breast implant labeling, including a boxed warning and a patient decision checklist that would be included at the end of a patient informational booklet or brochure. Once finalized, the labeling might also appear on the FDA’s website and on the websites of the breast implant manufacturers. In the meantime, breast implant safety advocates are trying to spread the word about the proposed new labeling so that patients will read it and ask their doctors about it.


What’s next?

It’s clear that awareness of implant safety issues is growing to some extent among doctors, patients, and the general public. But long-time observers question whether manufacturers and regulators will take enough of the steps that are needed to prevent future harm to patients. They point out that earlier attempts have been made to address public concerns about safety, such as the 14-year ban on silicone implants, and that both new and old safety problems haven’t been resolved.

“I am concerned that the present strategy of relying on the breast implant manufacturers to right the ship will produce more of what we have now: inadequate information about breast implant safety,” says Dr. DellaCroce. “In the meantime, the best we can do as ambassadors for our patients is to inform them of what we know, and maybe more importantly what we don’t know, to help them make the best decision for their long-term well being.”

Some patient activists want all healthcare professionals in various specialties to learn more about the risks of breast implants, so that the women who develop problems with their implants can get better care.

For example, Gretchen Goodell Bridge, a women’s health nurse practitioner from Arizona who had BII, spoke at the March FDA meeting about the need to educate all healthcare providers about the autoimmune symptoms that can be linked with breast implants.

“When a woman develops BII symptoms, she may wind up going to a dermatologist because her hair is falling out, a cardiologist because she has heart palpitations, and a rheumatologist because she has aching joints,” says Goodell Bridge. “That’s why we need to reach out to all healthcare providers, and not just plastic surgeons, to let them know about the symptoms that can be associated with having breast implants. Doctors should ask about whether a patient has breast implants on the intake form, just like they ask if the patient is a smoker.”

Like Goodell Bridge, many patient activists and their allies are committed to continuing to push for change and are feeling encouraged by recent events.

“I’m disappointed in the system, but we have to force change, and we are doing that,” says Raylene Hollrah, from Missouri, who had BIA-ALCL and is now part of the Breast Implant Working Group. “The first big step for us was getting the Allergan Biocell implants off the market, and now we need to improve informed consent and implant labeling. We have a long road ahead, but we’re not going anywhere.”

Stay tuned as continues to cover this unfolding story.

  1. Santosa KB et al. Long-term Patient-Reported Outcomes in Postmastectomy Breast Reconstruction. JAMA Surg. 2018 Oct; 153(10): 891–899. Available at:

  2. FDA. Medical Device Reports of Breast Implant-Associated Anaplastic Large Cell Lymphoma. July 2019. Available at:

  3. American Society of Plastic Surgeons. 2018 Plastic Surgery Statistics. Available at

  4. Coroneos CJ et al. US FDA Breast Implant Postapproval Studies: Long-term Outcomes in 99,993 Patients. Ann Surg. Jan. 2019; 269(1): 30–36. Available at:

  5. FDA Executive Summary: Breast Implant Special Topics. March 2019. Available at:


— Last updated on June 29, 2022, 3:16 PM

Center for Restorative Breast Surgery

This information made possible in part through the generous support of

Reviewed by 9 medical advisers
Sophie Bartsich, MD, FACS
New York-Presbyterian/Weill Cornell Medical Center, New York, NY
Mark Clemens, MD, FACS
University of Texas MD Anderson Cancer Center, Houston, TX
Frank J. DellaCroce, MD, FACS
St. Charles Surgical Hospital and Center for Restorative Breast Surgery, New Orleans, LA
Lu-Jean Feng, MD
Lu-Jean Feng Clinic, Pepper Pike, OH
Neal Handel, MD, FACS
David Geffen School of Medicine at UCLA, Los Angeles, CA
Matthew G. Stanwix, MD, FACS
Jan Willem Cohen Tervaert, MD, PhD
University of Alberta, Alberta, Canada
Robert Whitfield, MD, FACS
Austin, TX
Diana Zuckerman, PhD
National Center for Health Research, Washington, DC
Learn more about our advisory board