It wasn’t a decision Karen McDougal took lightly.
As a former Playboy Playmate of the Year, her career is built on beauty and fitness, but McDougal says her health deteriorated to the point she felt like she was going to die.
In January, McDougal made the decision to explant -- have her breast implants removed.
McDougal says she battled health problems – issues she now believes stemmed from her implants -- for more than a decade. Her health issues began eight years after she got her implants. McDougal said she would get sick for six to eight weeks at a time, get better for a month or two and then get sick again.
It became a running joke among McDougal’s family and friends that she was the “healthiest sick person.”
For a decade, doctors failed to diagnose the cause of her sickness. She said one doctor told her she was suffering from depression. Another told her that her implants looked great there was no need to replace them.
It’s emotional for McDougal to discuss getting to her lowest point when she truly thought she might die.
“I couldn't get out of bed,” she explained. “The noise sensitivity was so bad. I couldn't even tolerate my own voice because it hurt me so bad. The migraines were excruciating. I literally thought I was dying. All I could do was lie in bed.”
Thinking about what being sick did to her life makes McDougal want to cry – even now.
“Actually took my life away. I have a lot of family and friends who didn't know what I was going through,” she said. “So, you still laugh in the beginning, ‘Oh, you're always sick.’ ‘Oh, you're always this, you're always that.’ ‘You just don’t want to go out.’ ‘You're being lazy.’ So for awhile, it was kind of a joke but then, when they really saw me, and those who truly know me said. ‘You really are sick. What is going on with you? Is it really your breast implants?””
I couldn't get out of bed. The noise sensitivity was so bad. I couldn't even tolerate my own voice because it hurt me so bad. The migraines were excruciating. I literally thought I was dying.
~ Karen McDougal
Last October, McDougal thought her life was over.
“I laid in my bed and cried and I prayed every night,” she recalled. “Honestly, this was my prayer: ‘God don't take me tonight. Give me one more day. I have a life to live. Give me one more day.’ I have those days back now.”
McDougal believes information she found online saved her life.
After a friend told her his wife had been sick with similar symptoms and had her implants removed, McDougal started doing research. She found Facebook pages and websites with information on what women are calling “Breast Implant Illness.”
Nicole Daruda started a website called HealingBreastImplantIllness.com and Facebook group called Breast Implant Illness and Healing with Nicole after suffering major health issues she believes were caused by her implants.
In a phone interview, Daruda told me women are requesting to join the closed Facebook group at a rate of 100 per day.
The group is private because of the personal nature of the posts. Women share stories, photos, symptoms, advice, details of health problems and results of explanting.
[GRAPHIC IMAGE: Apparently intact implant with capsule]
In a matter of days, dozens of women reached out with their stories and pictures.
On the website, women share symptoms, including, but not limited to:
There are a number of ongoing themes in the posts.
CBS 5 heard from several women who say their doctors told them their symptoms couldn’t be caused by their implants. One woman sent us the email from her plastic surgeon warning her against medical opinions considering implants as a source.
In 2011, the FDA issued a report on the safety of silicone gel-filled breast implants, finding “reasonable assurance of safety and effectiveness when used as labeled. Despite frequent local complications and adverse outcomes, the benefits and risks of breast implants are sufficiently well understood for women to make informed decisions about their use.”
When asked for a statement on possible links to breast implant illness the FDA sent CBS 5 this statement:
“With the exception of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL), we do not have evidence linking breast implants to a wider range of illnesses. “
The FDA provided also provided a 2015 study from Tufts University.
For this investigation, I read through multiple studies, including the one provided by the FDA, which compiles data from more than 100 studies.
The 2015 Tufts study, which is 390 pages, examined possible links between breast implants and almost 90 conditions.
For almost every condition, disease and symptom, evidence was deemed “inadequate” or “insufficient” to determine if an association exists.
This study, like many, doesn’t say implants cause health problems, but it’s important to note that it doesn’t completely rule out the possibility either.
Studies often cite inadequate participation of women by the end of the study. It’s a problem that has been a part of research since implants were first introduced.
I talked to Dr. Diana Zuckerman, the president of the National Center for Health Research in Washington, D.C. She has a long history on breast implant safety.
“From 1983 to 1993, Dr. Zuckerman worked as a Congressional staffer in the U.S. Congress, working for the House subcommittee that has oversight jurisdiction over the U.S. Department of Health and Human Services, including the FDA,” according to her biography on BreastImplantInfo.org. “She was responsible for more than a dozen Congressional investigations and hearings on a wide range of health issues, including the first Congressional hearings on breast implants. It was Dr. Zuckerman’s congressional investigation of breast implants that first raised questions about the lack of safety data, which led to the FDA requiring safety studies of silicone gel implants in 1991. When the companies did not provide evidence that implants are safe, the FDA restricted their availability in 1992.”
Zuckerman said many studies over the years have been funded by organizations representing plastic surgeons and implant makers, all of which have a financial interest in making implants look safe.
She says the companies and organizations sometimes help shape studies with results that are not scientifically valid.
Zuckerman also said some studies might have been manipulated in a number of ways.
One very effective way to have studies proving that a product is safe is to just get rid of the patients in the study who aren't feeling well -- just stop talking to them and stop asking them how they are.
~ Dr. Diana Zuckerman
“I’ve spoken with some of the women in some of the studies who said as soon as they started complaining to their plastic surgeon about how sick they were feeling, suddenly they stopped hearing from the plastic surgeon about coming in to continue the study,” she said. “Suddenly, they weren't in the study anymore. One very effective way to have studies proving that a product is safe is to just get rid of the patients in the study who aren't feeling well -- just stop talking to them and stop asking them how they are.”
Zuckerman said there are additional problems with some studies, including basing data on hospital records when most symptoms of chronic illnesses, such as fatigue and hair loss, do not require hospital stays. Also, many studies are done over short periods of time, between two and five years after the implant surgery, when illness may not start showing until several years later.
Zuckerman says if a woman decides to have her implants removed, there is a specific procedure. The implants must be removed with the scar tissue that forms around each implant, the capsule, still in place.
[WATCH: About explanting]
For this investigation, I asked the American Board of Plastic Surgery to connect me with a plastic surgeon who could speak about breast implant safety.
Mahabir says in his field, it would be unusual to work with a woman who believes her implants made her sick.
“The point I want to make, first and foremost, is that implants are safe,” Mahabir said in no uncertain terms.
He said studies have shown implants are safe.
When it comes to testing to see if an implant could be the source of a health issue, Mahabir said the only test available would be an MRI, which can only determine if an implant has ruptured. Without tests to determine if implants are the source of an illness, explanting is often a last resort after women go through extensive medical testing.
The point I want to make, first and foremost, is that implants are safe.
~ Dr. Raman Mahabir
During this investigation, CBS 5 was not able to find any databases tracking the number of women, outside of studies, who have reported to their doctors illnesses possibly connected to their implants, concerns some women say are often ignored by their doctors.
The FDA has an online form where women can report problems -- Manufacturer and Facility User Device Experience (MAUDE)
CBS 5 asked the FDA for numbers on how many women have reported symptoms possibly related to breast implant illness. The agency referred us to its database where individual reports could be looked up.
Its own study on safety identified a number of issues with having individuals file complaints.
“It is difficult to know whether or not the implant caused or contributed to the adverse event based solely on information provided in a report. Establishing a cause and effect relationship is especially difficult if the device is not examined or if the analysis was inadequate.” ("FDA Update on the Safety of Silicone Gel-Fill Breast Implants." FDA.gov. U.S. Food and Drug Administration, June 2011. Web. Page 25)
McDougal has been criticized for publicly connecting her implants to her illness.
She received a message from a representative of an implant maker, saying there was “no science to prove a connection,” and called her irresponsible for using her celebrity platform.
McDougal was disappointed following an appearance on the television program “The Doctors,” which airs weekdays on our sister station 3TV. She said she felt they didn’t give her the opportunity to share her story while the show’s plastic surgeon defended the safety of implants.
An overwhelming message from women who believe their implants made them sick is that they are frustrated.
In 2015, more than 40,000 women had their implants removed for a wide range of reasons.
McDougal says what women need is information so they can make an informed decision. She’s now committed to bringing whatever attention she can to the issue.
“Don’t hide things because it's a multi-multimillion dollar business. Tell us what the risks are and let us make an informed decision.”
[GRAPH: Cosmetic breast surgeries in 2015]
Copyright 2017 KPHO/KTVK (KPHO Broadcasting Corporation). All rights reserved.
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