Told their problems are in their heads.
When thousands of people with similar symptoms report getting sick, there is typically an interest or effort to pinpoint the source.
An interesting phenomenon is being reported across the country: Women who believe their breast implants are making them ill say they are struggling to get doctors to listen to them.
More than 32,000 women have joined the Facebook group Breast Implant Illness and Healing by Nicole. It's a closed group that includes thousands of women who believe breast implants made them sick.
In posts, women share stories of symptoms including memory issues, fatigue, allergies, pain and the list goes on.
[VIDEO: Breast Implant Illness: A search for answers] Part 2
Some women report symptoms so severe they say they can barely function. Some have lost jobs and relationships. There are also daily posts from women who claim their health improved after their implants were removed.
For the last year, reporter Kris Pickel with CBS 5 has been investigating claims that breast implants make women sick. The investigation into what has become known as "Breast Implant Illness" began after former Playboy Playmate Karen McDougal talked to Pickel about having her breast implants removed.
Now, almost a year after having her implants removed, McDougal said she has gone from feeling like she could die any day to being "98 percent better."
As part of this ongoing investigation, Pickel followed three women through having their implants removed, including McDougal's sister Tina. The surgery is known as “explanting." The stories of the three women mirror many stories from women who believe they suffer from Breast Implant Illness.
Their stories: 3 women have their breast implants removed
Tina McBain (left), Melissa Harmon (middle) and Karen all opted to have their implants removed.
Tina McBain is a mother of five who said her exhaustion was so severe that she, at one point, slept for three days with her children unable to wake her.
Melissa Harmon said she was in so much pain she hadn't been able to work in more than two years.
Karen said she was an avid runner, but pain and exhaustion left her with so little energy she basically worked and slept.
None of the women wanted to have their implants removed but desperation to feel better drove them to take the step. All three women said doctors told them their problems were in their heads. They came to their decisions to explant based largely on information they found online in social media groups.
Prior to having their implants removed, the women listed the symptoms they believe were caused by their implants. The highlighted symptoms are the ones they say got better or disappeared after having their implants removed.
The FDA said implants have a "reasonable assurance of safety."
- FDA: Breast Implant Complications
- FDA: Risks of Breast Implants
- FDA: Breast Implants Linked to Lymphoma
[MORE: Breast implant resources]
Previous studies on breast implants
A previous CBS 5 investigation by Pickel found numerous studies on breast implants contain "insufficient evidence" to determine if implants are linked to a wider range of illnesses. The studies don't contain enough evidence to establish links to various illnesses, however, the studies do not rule out the possibility.
A study in the Netherlands Journal of Medicine tracked women with unexplained illnesses who had their implants removed. A majority reported improvements in their health.
If breast implants make women sick, then how?
CBS 5 is focusing on the question: If breast implants make women sick, how? The search for answers took Pickel to Canada to interview Dr. Pierre Blais.
Blais is an organic chemist who said he left his position as a senior scientific adviser with Canada's equivalent of the U.S. Food and Drug Administration over his concerns the government was failing to protect women from the potential dangers of breast implants.
Blais had a rocky relationship with the Department of National Health and Welfare of Canada. In 1989, after raising questions about the safety of breast implants, Blais was fired, later rehired, then left the agency.
Blais has testified before U.S. Congressional committees on the safety and effectiveness of implants. He now runs Innoval Failure Analysis, an independent consulting firm that analyzes failures in medical devices including breast implants. Over the decades Blais said he has studied around 20,000 tissue samples and implants.
The findings are sometimes controversial. Blais testifies as an expert witness, which critics say makes him biased against implants because he's paid for testimony. In some cases, his testimony has not been allowed for assorted reasons, including that he is not a medical doctor.
Defective implants are not always the problem, according to Blais, who said implants trigger reactions in a woman's body. Blais said the reactions are the body's attempt to protect itself from a foreign object, but the body's attempt to protect itself can create problems.
While implants come with warnings, Blais' research covered several issues women said they were not warned about.
We reached out to the FDA and implant makers Mentor, Allergan and Sientra for comment. Allergan did not return our calls or emails. Mentor responded they have no comment. Sientra and the FDA answered some of our questions.
The research of Dr. Pierre Blais
“We find microorganisms as a rule. We look upon implants that are still sterile after three to four years as an unusual," said Blais.
Blais said his research shows implants are “prone to contamination." Papers he has published list mold, bacteria and yeast tied to a lengthy list of potential problems, including allergic reactions, infections, pneumonia, meningitis, arthritis, immunity issues, skin and blood infections, and the list goes on.
Blaise said tests done after explanting tissue or implants may not show the presence of the microorganisms because most are slow-growing and take weeks to grow in a culture. These more extensive tests are expensive and not routine.
[PUBLISHED RESEARCH BY BLAIS: Guidelines on Microbiological Evaluation of Saline-Containing Implants and Capsular Tissue]
Breast implant manufacturers and the FDA lists infections as a possible risk but do not go into extensive detail.
“Occurs when wounds are contaminated with microorganisms, such as bacteria or fungi. Most infections resulting from surgery appear within a few days to a week, but infection is possible any time after surgery. If an infection does not respond to antibiotics, the implant may need to be removed.”
Capsules form around every implant and are composed of scar tissue. It is a natural process and the body's way of protecting itself from a foreign object.
Blais said over time the capsules become thicker creating an impermeable barrier, keeping the implants in a stagnant situation. This can cause a multitude of problems including conditions for microorganisms to breed.
Blais said there is a continuous buildup of tissue on the outside of the capsule while the inside, the area closest to the implant, after time starts to break down and rot.
Cracks can eventually form in the capsule leaking what was inside the capsule into the woman's system.
The capsule changes continuously and it changes for the worst.
~ Dr. Pierre Blais
Information on capsules is limited.
The FDA and implant manufacturers list capsular contracture as a risk.
Under Complications, the FDA describes capsular contracture as a “[t]ightening of the tissue capsule around an implant, resulting in firmness or hardening of the breast and squeezing of the implant if severe.”
Calcification or mineralization
Blais said as implants get older, inside the capsules start to form hard bone-like materials -- calcification or mineralization as rotting tissue releases minerals.
Under the microscope, Blais said the formations look like broken light bulbs shards. He called this “the end of the game,” saying the materials are abrasive and can wear away at both the capsule and the implant.
Blais said during this phase the pH balance goes up increasing the acidity or alkalinity in the area between the implant and capsule. He said the higher pH balance rots the silicone shells.
It should be noted that all breast implants are made with silicone shells. Even saline implants have silicone shells.
Funny thing. Silicone shells are not resistant to alkaline, so the shell begins to rot and it changes in shape. You can see it. It’s not rocket science.
~ Dr. Pierre Blais
WARNING: GRAPHIC VIDEO
The following video was made by Dr. Victor Urzola in Costa Rica. The graphic video shows the examination of capsules that had just been removed from a patient. We showed the video to Blais, who said it’s an example a capsule rotting on the inside.
[APP USERS: Click here to watch the YouTube Video]
A representative from implant maker Sientra sent CBS 5 an 80-page educational brochure listing potential problems.
Alkalinity is not discussed, however, implant makers like Sientra warn patients that implants are not lifetime devices and may require replacement.
It’s not uncommon to see saline implants with various types of growth inside. Blais said in his lab he has been able to re-create that valves in many saline implants do not permanently seal.
He compares the valves to acting like a piston, allowing saline out and body fluid back in. The back-and-forth leads to contamination.
You get bugs in and you get bugs out.
~ Dr. Pierre Blais
Breast implants are medical devices regulated by the FDA. Pickel asked the FDA to comment on Blais’ faulty valve claims and included pictures sent to her by women across the country showing values that appear to be discolored or clogged. A representative from the FDA responded, saying they will look into the information.
According to Blais, if a surgeon has done a good job, an implant should not initially cause problems. However, as the capsule locks into the surrounding tissue, the area around it may contract. This can lead to a variety of issues.
Blood vessels can start to contract, close or disappear altogether.
He said sometimes veins start to appear near the surface of the skin.
Another problem can occur when pressure is put on blood vessels that feed the heart. Blais said women sometimes experience intermittent chest pains but EKGs and ECGs are normal. Even the simple act of breathing can be affected as the capsule attaches to the chest wall. As a woman breathes, her ribs separate a little bit from one another. The muscle in between the ribs is the intercostal muscle.
Blais said over a period of years, the buildup of scar tissue can lock the ribs and prevent the chest from expanding. This forces the woman to breathe using her stomach.
Blais said in some autopsies now being done on women who have had had implants for 20 to 30 years, structures have formed from scar tissue inside the chest that no longer look human.
We're seeing breast implant users 20 to 30 years in for the first time. They're not pretty to look at. The chest no longer looks human.
~ Dr. Pierre Blais
We reached out to Dr. David Rankin, who is the chief of plastic surgery at St. Mary's Medical Center in Florida. McDougal and her sister, Tina, both traveled from Arizona to Florida to have their surgeries performed by Rankin. He performs both implants and explants and points out that most women with implants have no problems.
However, he feels there is a percentage of women who “react” to having a foreign body in their systems.
We asked Dr. Rankin for his perspective on the potential for breathing problems.
“When placed under the muscle, scar tissue usually always attaches to the rib periosteum (this is basically the chest wall and ribs) which is a normal finding in women with breast implants. Again, it usually causes no problem or discomfort. When capsular contracture occurs (hardening of the scar tissue or capsule), women may experience pain and palpability of the capsules and an abnormal shape to the breast. Many of my explant patients do claim to be able to breathe easier once the capsule is fully removed.” -Dr Rankin
Implant removal procedure called En Bloc
Blais is among the experts who recommend removing implants with the capsule intact. The procedure is called an En Bloc.
Blais said if the capsule is left inside, even if it is broken up, it can create health issues, including an abscess where the area refills with body fluids. Typically, when implants are removed, the capsule is left inside the woman’s body.
Rankin said many patients come to him specifically to have their capsules removed but it is not considered standard care.
“The general thought for years has been that normal soft capsules and even more thickened capsules did not pose risks. However, for the patients that are experiencing systemic illnesses, I feel it is better to fully remove the capsules. The true answer at this time is that we don't have a scientifically based and proven answer on this. Further study is definitely important.” -Dr. Rankin
Breast augmentation is a billion dollar a year industry
There are millions of women with breast implants. In studies, most women do not report negative side effects, but the implant industry may start tracking problems.
The National Breast Implant Registry (NBIR) is a new database rolling out this year by The Plastic Surgery Foundation to collect information on implant procedures and devices. Surgeons will be encouraged to enter information that can help identify trends and identify potential complications.
While the database may provide long-term information, if surgeons participate, there still does not appear to be any studies planned specifically targeting women with unexplained illness and implants.
All three women we followed in this investigation say they were told by numerous doctors that their implants could not be the source of their illnesses but when their implants were removed, they say their health improved significantly.