PHOENIX (3TV/CBS 5) -- A new study may be a game changer in the debate: Is breast implant illness real? Plastic surgeon Dr. Lu-Jean Feng designed the study involving 750 women with a diverse mix of breast implants, including silicone and saline, with shells that were either smooth or textured.
Every patient underwent a total capsulectomy. It's a surgical procedure which removes the breast implant and all surrounding scar tissue, known as the capsules.
Prior to surgery to remove the implants, patients rated the severity of 11 symptoms commonly associated with breast implant illness, on a scale from 0 to 5.
Symptoms rated in study:
- numbness and tingling in the extremities
- joint and/or muscle pain
- hair loss
- memory loss/cognitive problems
- dry eyes and/or blurred vision
- chronic fatigue
- breast pain
- rashes and/or hives
- food sensitivity/intolerance
- flu-like symptoms and/or low-grade fever
- difficulty breathing
Ten days after their implants were removed, the women rated their symptoms again and repeated the survey multiple times over the next year. The data was then analyzed by a team at Case Western University led by Dr. Corinne Wee and published in the Annals of Plastic Surgery.
After years of seeing her patients' health improve following the removal of their breast implants, Dr. Feng says the results still came as a surprise. "I didn't think it would be this good," says Dr. Feng. When averaged out among the group, almost every symptom improved. Most symptoms drop to ratings considered 'none' or 'mild'.
"For each one of these symptoms, there is a statistical difference so it's not by chance anymore that they improve," says Dr. Feng.
Researchers found health improvements happened quickly. If a woman saw improvements within the first ten days after surgery, the benefits were still present a year later. The most significant improvements happened in women who were obese or had some type of hardening of the scar tissue around the implant and who made lifestyle changes such as eating a healthy diet and exercise.
CBS 5 Investigates looks into breast implants making women sick. A full report tonight at 10pm.
Removal of saline and silicone implants resulted in similar levels of improvements. The study notes "silicone is actually present in the shells of many saline implants."
During years of investigations, numerous women have shared first-hand accounts with CBS 5 Investigates, saying when doctors failed to diagnose the cause of their symptoms, they were led to believe their symptoms were psychosomatic or the result of aging.
Dr. Feng says her study debunks the theory that breast implant illness is something women are imagining. "It is not in their heads," says Dr. Feng. "This is my life's work mainly because it's such a simple solution. You take out the implant and all the surrounding scar tissue that houses the inflammatory reaction and the implant derived material, and the patient gets better."
DIFFERENT THAN PREVIOUS STUDIES
For breast implants illness advocates, Dr. Feng’s study provides scientific evidence to back up claims made by tens of thousands of women.
Dr. Diana Zuckerman is President of the National Center for Health Research in Washington DC. An expert on national health policy, Dr. Zuckerman has worked for decades to get stronger warnings on the risks of breast implants. "This study absolutely confirms that there are women getting sick from their breast implants, and when their implants are taken out, they get well," says Dr. Zuckerman.
In analyzing decades of previous studies, Dr. Zuckerman says major studies sponsored or conducted by breast implant manufacturers have a created a misleading perception surrounding the safety of implants.
Dr. Zuckerman says many studies funded by breast implant manufacturers have been small or short-term. The FDA required Allergan and Mentor to each conduct a study of 40,000 women for 10 years after they got implants. She says the studies were not completed as designed.
Thousands of women dropped out of the studies after just a couple years. In some cases, she says, women were kicked out of studies if they got sick. She also points out it can take sometimes 5-10 years or longer for symptoms to develop, which means many women drop out of studies before they start to experience problems.
As an example, Dr. Zuckerman cites the 10 year post-approval study by breast implant manufacturer Mentor on its MemoryGel CPG Breast Implants.
She says seven years into the study, 80% percent of the 41,000 women were no longer participating in the study.
Mentor provided CBS 5 Investigates with final data from its post-approval study showing that of the 41,452 women enrolled in the study only 6,063 completed the study.
WARNING LETTERS TO IMPLANT MANUFACTURERS
In the past year and a half, the FDA issued warning letters to breast implant manufacturers for not complying with safety study requirements.
In March 2019, the FDA sent a warning letter to both Mentor and Sientra regarding serious problems in their post approval studies. The FDA noted Mentor failed to enroll enough patients in the study on Memory Shape breast implants. They also cited poor follow-up rates and a lack of patient diversity.
Sientra's study on Silicone Gel Breast implants was found to have serious deficiencies including not enough participants and insufficient follow up rates with patients.
In May of 2020, the FDA issued a warning letter to Allergan citing the company failed to comply with study requirements on long-term safety and risks of two breast implant models. The models were voluntarily recalled because of an increased risk of cancer.
BIA-ALCL is a type of non-Hodgkin's lymphoma that forms in the scar tissue around an implant.
In August 2020, the FDA updated the number of known cases of BIA-ALCL to 733 with 36 deaths worldwide. Those numbers represent an increase of 160 new cases with 3 additional deaths.
A previous CBS 5 Investigation focused on a why doctors may be missing the symptoms of the rare cancer.
The warning letters gave manufacturers 15 days to detail how the violations would be corrected, but months later, the FDA refuses to provide details on if or how the studies have been fixed.
Mentor was the only manufacturer to respond to questions, stating they had "aligned on a solution" with the FDA that allows them to meet the study requirements. The implant manufacturer would not provide further details.
Mentor was also the only manufacturer to provide a comment on Dr. Feng's study:
“While BII is not a medical diagnosis, and the current body of scientific evidence does not support claims that breast implants cause systemic illness, the FDA, industry and medical and plastic surgery societies are taking steps to better characterize the set of symptoms and their risk factors. We support these efforts and have been partnering with researchers, surgeons and health authorities around the world, listening to patients, and diligently reviewing our long-term implant safety and complaint data to better understand any possible connection between the symptoms women are experiencing and breast implants. Mentor is aware of the recent retrospective study in APS regarding BII. As noted by the authors, the study has several limitations and additional long-term prospective studies with objective measures of symptoms are needed."
LACK OF SCIENCE VS. REAL WORLD EXPERIENCES
The medical community, breast implant manufacturers, CDC and FDA routinely cite a lack of scientific evidence establishing a link between health problems and breast implants.
In the past few years, tens of thousands of women have come forward claiming their breast implants made them sick. Much of the awareness is brought about by social media, not doctors.
The largest Facebook group dedicated to breast implant illness, "Breast Implant Illness and Healing by Nicole" now has more than 125,000 members, with hundreds of women joining daily.
Under pressure from the growing social media movement, the FDA held a public meeting on the safety of breast implants. At the end of 2019 the FDA added "breast implant illness" on its website under "Risks and Complications of Breast Implants."
FDA RECOMMENDS NEW WARNINGS FOR BREAST IMPLANTS
On September 29, 2020 the FDA took their strongest steps to date to increase awareness on the risks of breast implants.
The agency is recommending labeling for breast implants include a box warning, the strongest warning by the FDA that a product carries the risk of serious injury or death.
While the FDA did not mandate manufactures include the warning, they recommended the following information be included: breast implants are not lifetime devices; are associated with the cancer of the immune system BIA-ALCL; patients have died from BIA-ALCL; patients have reported systemic symptoms such as joint pain, muscle aches, confusion, chronic fatigue, auto immune disease; and that some patients recover from the symptoms after implants are removed.
The recommendations are carefully worded to acknowledge recovery from systemic symptoms may happen after implants are removed. However, the FDA stopped short of saying the implants cause the symptoms.
The FDA is also recommending a checklist for women to be given when considering breast implants. The checklist would outline when implants should not be used; risks of implant surgery, cancer, systemic symptoms, rupture and complications; updated screening and follow up tests, implants are not lifetime devices and alternatives to implants.
The FDA says the labeling recommendations are intended to enhance but not replace discussions between patients and their physicians.
There are countless cases of women who say the symptoms associated with breast implant illness damaged or destroyed not just their health, but their lives, relationships and careers. Some can't take care of their families. Some can't work. Many can't afford the cost of surgery to have their implants removed.
CBS 5 Investigates has spoken with women who say they spent several years along with tens of thousands of dollars on medical tests, trying to diagnose the source of their unexplained health issues. They say doctors discounted any possible connection to their breast implants.
Surgery to remove implants and surrounding tissue can cost anywhere from $3,000 to more than $10,000. The price tag surges higher depending on the surgeon, facilities and additional procedures, such as lifts to improve the appearance of the breast.
CDC SHUTS DOWN INSURANCE COVERAGE EFFORTS
Efforts to make breast implant illness an official diagnosis covered by insurance came to a sudden stop earlier this year.
Dr. Zuckerman was among the advocates invited to speak at the CDC’s March meeting on ICD-10 codes. The codes are used to diagnose medial conditions and show insurance companies why treatment is necessary. Without the codes, insurance companies will not cover the cost of treatment.
Dr. Zuckerman planned to attend the meeting and built a presentation. She says without explanation, she was notified the agency would not be exploring the option of ICD-10 codes for breast implant illness. "I was not given a reason why, other than it was considered too controversial," says Dr. Zuckerman.
After months of requests to the CDC asking for an explanation as to why the topic was dropped from their agenda, the agency sent an email to CBS 5 Investigates stating, “There is no definitive evidence that breast implant cause the systemic symptoms."
The agency also provided a list of ICD-10 codes providers can use for treatment and billing covering conditions ranging from breast deformity to atrophy.
However, the current ICD codes do not cover the symptoms commonly associated with breast implant illness such as fatigue, rash, joint pain and cognitive issues.
Efforts have not stopped to get ICD-10 codes for breast implant illness. Congressman Lloyd Doggett of Texas and Congresswoman Rosa DeLauro of Connecticut sent a letter to CDC Director Dr. Robert Redfield asking for clarification on why the topic was dropped.
Their letter references a growing body of research that thousands of women have been seriously harmed by breast implants and that "women continue to be denied health insurance coverage for medically necessary implant removal."
Representatives Dogget and DeLauro point out women who elected to undergo breast implant surgery were "unaware of the potentially serious risks."
Social media may once again hold the key to pressuring the government to take action. The nonprofit BISA, Breast Implant Safety Alliance, is circulating a petition calling for the "FDA & CDC to develop a medical code for sick women suffering from breast implants."
The petition has nearly 11,000 signatures.
Robyn Towt is Secretary and Legislative Liaison for BISA. A breast cancer survivor, Towt says she was pressured to get breast implants after a double mastectomy. She says she immediately started suffering symptoms of breast implant illness that improved once she had her implants removed.
Towt says, despite e-mails and phone calls, the CDC is refusing speak with breast implant illness advocates.
The agency sent Towt an e-mail calling the need for a code for the treatment of breast implant illness "premature". The e-mail went on to say that although some women say they experienced improvement after removing their implants, the evidence is that implants caused the symptoms is insufficient.
Towt believes the CDC ignoring the experiences of women and evidence gathered by advocates and only paying attention to studies presented to them by implant manufacturers and plastic surgeons. "There are dozens, even hundreds of studies that show silicone toxicity. I think probably the biggest problem is the disconnect of which studies and science they're actually choosing to listen to," says Towt.
Dr. Feng’s study was published after the CDC made the decision to drop the breast implant illness from their agenda. Breast Implant illness advocates hope the CDC will take the new study under consideration and issue the ICD codes to help sick women get their implants removed and their health back.
Q & A WITH DR. LU-JEAN FENG
Q: What was your motivation for doing this study?
A: My motivation is that I've seen many patients with significant, unbelievable improvement after total capsulectomy (surgical removal of scar tissue around a breast implant). I wanted to establish that is a diagnosis, there is an entity called breast implant illness and it's not related to autoimmune disease or other known inflammatory diseases.
In the past it's been called many different names; human adjuvant disease, silicone tolerant disease, ASIA syndrome.
It's very unique because patients with breast implant illness respond dramatically to total capsulectomy. That is the reason we're doing this study. Unless we can follow the patients and really document what has happened to their symptoms after explantation (removal of implants), unless we follow it in a more precise quantitative manner, we will never know.
Q: How was the study designed?
A: We use a symptomatic survey tool. I came up with the eleven most common symptoms that characterize the illness and that I thought patients would find improvement after explantation.
The disease is not organ based. It's not breast pain, a neurological illness or joint pain. It's a combination because it really is a cellular effect. It's affected by the different chemicals that come from the silicone or saline implant so it would be fatigue, brain fog, dry eyes, blurry vision , dry skin, rash or hives, joint or muscle pain. For neurological issues will be will be numbness and tingling. There's also food intolerance, bloating, irritable bowel certain symptoms. There's difficulty breathing as well. People can't take a deep breath. Flu like symptoms, low grade fevers.
Q: How were the women monitored?
A: We started collecting data from 2017 and 2018. We had the patient fill out a survey right before explantation rating the severity of their symptoms from minimal, mild, moderate, moderately severe to severe. Severe would be more intense symptoms, more frequent symptoms. The rating goes from zero to five.
We would then have them fill the survey out again after the surgery. Some would fill it out at less than 10 days then six weeks, three to four months, six months and a year.
What we found was that if you experienced improvement by day 10, it usually sustains itself at three to four months and beyond. Not everyone followed up at one year, but for the onset we were able to follow for the year, they sustained the improvement. We also found that people need to have good diet and good lifestyle choices. When they combine implant removal with a more plant based diet, low sugar, no grains and more anti-inflammatory diet, they improve even to a much greater degree.
Q: There were 750 women in the study. How significant were the improvements?
A: There is a statistically significant difference so it's not by chance anymore that the women improved. We were able to show a statistically significant difference.
To give you an example, for 'fatigue' people in general registered a 3.5 score, somewhere between moderately-severe. Afterwards they register 1.3 which is mild-moderate.
Q: So women who suffered from severe fatigue had mild fatigue after?
A. Yes, that's correct in general, that's like an average score. So we have patients that maybe improve from 5 to 2 or patients that may improve from 4 to zero. If you average them all up, that's the average score.
Q: Were you surprised by the results?
A: Yes, I actually was. I didn't think it would be this good. I did not analyze the data. All the other authors are from Case Western Reserve plastic surgery division. The Plastic Surgery Resident Corinne Wee, MD led the study and recruited a group to participate in the collection and analysis of the data. That took a lot of effort. A lot of hours of going through charts and recording these different scores. A medical statistician then did the statistical testing. They were also able to compare which patients had the most improvement.
We also found that the patients who are obese have the most improvement. Patients who had contracture or tightening of the scar tissue also saw the biggest difference.
Q: What is the reaction from the medical community, when you discuss breast implant illness as a real medical condition?
A: Up until this paper, it's been really doubted. Some of the other specialties like functional medicine would acknowledge it that that could exist. People who study toxins or more alternative medicine would acknowledge it. Hopefully these type of papers makes it into the mainstream medical literature to educate other surgeons and other medical practitioners that breast implant illness does exist. It should be in the back of their mind when they see patients with this combination of symptoms to maybe ask, 'Do you have fatigue?' because in a lot of these patients the symptoms may mimic hypothyroidism, but their lab values are normal. It's obviously not hypothyroidism. It can mimic Lyme disease. It could mimic mold toxin illness. It could mimic many other conditions. It could mimic autoimmune disease, but they may not have all the criteria for the autoimmune disease. They should think about the breast implants because once you remove the capsule and the implants they get better.
It would be nice if women are not left not knowing what they have and continue to be in a state of terrible quality of life.
Q: What does this do to the argument from a lot of plastic surgeons that breast implant illness is just in women's heads?
A: It totally debunks it. It is not in their heads. There is something about these implants that produce toxins in certain individuals. They don't handle these toxins well or they don't detox well or they have more of an inflammatory response to them or some other genetic factor that could trigger all these symptoms. Whether doctors listen to the to the data or not, that's up to them but I'm sure there will be other medical practitioners who read the paper will have that in the back of their mind so that they can help patients.
Q: What else should people know about this study?
A: I think our next frontier is going to be the genetics of breast implant illness because not everybody gets it and some people get it a little bit later after having implants. Others get it sooner. I'm pretty sure the manifestation of illness is highly correlated to the genetics.
This study seems to be a game changer providing scientific evidence that breast implant illness exists.
I'll be continuing to work towards further characterizing and defining this illness.
That really is my life's work mainly because it's such a simple solution. You take out the implant and all the surrounding scar tissue that houses the inflammatory reaction and the implant derived material and the patient gets better. That's better than a drug or a number of drugs to try to treat the individual symptoms. It's better to get down to the root cause and have all the symptoms disappear.
Q: Any push back on the study?
A: I think the push back is more from my own colleagues who do a lot of breast implants because this will affect their business. If patients know that breast implant illness exists, they wouldn't get the implants.
Kris Pickel is a nine time Emmy Award-winning reporter. Her investigations on breast implants earned a regional Investigative Emmy and national Emmy nomination. Click here to see more of her investigation on breast implants.