Laurie McGinley, The Washington Post: October 23, 2019.
Mary Kekatos, Daily Mail: December 19, 2018.
A fitness blogger said she had her breast implants removed because the silicone was ‘poisoning’ her.
However, over the next seven years, the Florida mother-of-two struggled with extreme fatigue, facial rashes, chest pain, brain fog and even hair loss.
After undergoing multiple blood tests, diagnostic tests and X-rays that came back negative, Cooper was convinced her symptoms were related to what described as ‘breast implant illness’.
Cooper decided to get implants in October 2011, after she lost around 45 pounds and was left with ‘non-existent’ breasts.
‘I’d recently gone through a pretty hefty loss from 150 pounds to 105 pounds and I didn’t feel confident,’ she told DailyMail.com.
‘My husband at the time saw I was unhappy and suggested I should get implants to jazz up our sex life.’
The most popular implants approved by the US Food and Drug Administration (FDA) are silicone implants and implants filled with a saline solution.
Silicone implants use shells filled with a plastic gel while saline implants use silicone shells filled with a sterile saline solution.
For breast reconstruction, the rebuilding of a breast, both implants are approved for women of all ages.
For breast augmentation, meant to increase the size or change the shape of a breast, saline implants are approved for women aged 18 or older and silicone implants are approved for women aged 22 or older.
Cooper opted to get 400 cc silicone gel implants, which were inserted through her armpits without leaving any scars and left her with a 32DDD/34DD cup size.
When she woke up after surgery, Cooper said it felt like ‘an elephant sitting on my chest’.
Cooper said she didn’t experience any other symptoms until about a year after surgery.
First there was the fatigue that left her sleeping sometimes between 12 and 14 hours per day.
Then, she started losing her hair in clumps after her first son was born in 2014 – three years out from her cosmetic surgery.
‘I was told postpartum hair loss is normal but temporary,’ Cooper said.
‘It didn’t go away. I was checked for hormone imbalance and hyperthyroidism but was told I was fine.’
In addition, she experienced rashes on her face and back, a 20-pound weight gain and constant joint inflammation.
‘I just chalked it up to aging but, at the same time, I’m 29 I shouldn’t be having this problem.’
Over the summer, in an unrelated Instagram post, she revealed to her followers that she’d had a breast augmentation.
‘They started pointing out breast implant illness to me,’ she said. ‘And I started thinking: “Maybe this is it.” Because all these blood tests, diagnostic tests were coming back negative.
The FDA does not recognizes breast implant illness as a diagnosis but, on its website, urges doctors to not dismiss patient concerns until ‘much larger and longer’ studies are conducted.
Recently, a number of women who’ve undergone breast augmentations have come forward complaining of symptoms similar to Cooper’s.
In the early 1990s, the FDA prohibited silicone implants after several health concerns were raised about their association to a risk of cancer, connective tissue disease and autoimmune diseases.
No research established a definitive link between silicone implants and these conditions.
After silicone implants from two manufacturers were approved in 2006, the FDA conducted many post-approval studies, but no researchers had analyzed the database.
Cooper first visited her original surgeon, who told her there was little evidence to support BII and that her concerns were in her head.
‘He told me I would be disproportionate if he took them out,’ she said.
She decided to call Dr Jae Chun, a cosmetic surgeon in Newport Beach, California, who specializes in breast explants.
‘We made a phone consultation and from the moment he said hello, he answered all my questions,’ she said.
Two weeks ago, Cooper traveled from her home in Destin to Dr Chun’s office for the surgery, which cost $7,600 – $2,100 more than her augmentation cost in 2011.
‘I’d forgotten what it was like to take deep breath because I no longer have this feeling of an elephant sitting on my chest,’ she said.
In September, the largest study of breast implant outcomes to date was released by the University of Texas MD Anderson Cancer Center in Houston.
Looking at FDA post-approval studies, the team found that silicone implants can increase a woman’s risk of arthritis, stillbirth and even skin cancer,
The authors noted that although certain risks were more common in women with silicone implants, ‘absolute rates of these adverse outcomes were low’.
‘To reduce their chances of getting ill, women should not consider breast implants if they have a family history or personal history of autoimmune disease or connective tissue disease,’ Dr Diana Zuckerman, President of the National Center for Health Research, told DailyMail.com.
‘We believe that could be one of the causes behind why some women get sick after getting breast implants, although it is definitely not the only reason.’
Doctors in general believe that autoimmune diseases are generally underdiagnosed.
Cooper, who is now a 32C, said she wishes she’d asked more questions before her augmentation and encourages other women to do so before getting implants.
‘Be your own health advocate. If you feel something is wrong, it probably is,’ she said.
Diana Zuckerman, PhD, Cancer Prevention & Treatment Fund
In 2013, a study showed that a rare cancer of the immune system, ALCL, which had previously been linked to saline breast implants and silicone breast implants, was caused by breast implants and could be fatal. The latest research indicates that this cancer is sometimes cured by removing the breast implants, but at other times also requires radiation and chemotherapy; in some cases, the patients died despite treatment. Although the FDA had reported in 2011 that ALCL might be caused by breast implants, the agency didn’t update its website when the 2013 study was published. It took the FDA more than 3 more years to revise articles on its website indicating that breast implants caused ALCL ( to conclude that breast implants could cause ALCL. The FDA reported that they have received 359 reports of ALCL among women with breast implants through February 2017. It’s likely there are still numerous unreported cases; for example, Australia’s medical agency estimates that one in 1,000women with breast implants develops ALCL. There is no reason to think American women would be less likely to develop ALCL, and that would result in several thousand U.S. women developing ALCL
This is just the latest bad news for women with breast implants, and for the government agencies that have allowed them on the market with inadequate studies or warnings. For example, in 2011, tens of thousands of defective breast implants made by PIP were recalled in Europe. An article in the December 2012 issue of the British medical journal Reproductive Health Matters explains how these developments illustrate the strengths and weaknesses of the safeguards intended to protect patients in different countries from unsafe breast implants and other medical devices. In the U.S., breast implants are regulated as high-risk medical devices that must be proven reasonably safe and effective in clinical trials and subject to government inspection before they can be sold. This standard is higher than the FDA requires for hip joints, numerous cardiac devices, and many other medical implants. In contrast, clinical trials and inspections have not been required for breast implants or other implanted devices in Europe. As a result of these differing standards, the PIP breast implants that were recalled across Europe had already been removed from the U.S. market years earlier. The FDA was justifiably proud that they had done a better job of protecting breast cancer patients and cosmetic augmentation patients than the EU regulatory system. Nevertheless, the FDA track record on breast implants shows how limited those safeguards can be. The FDA required two breast implant companies to conduct enormous 10-year studies of breast implants, but has done little to ensure that the studies are providing useful information to patients.
The authors conclude that neither the European Union nor the U.S. has used their regulatory authority to ensure the long-term safety of breast implants. However, in 2012 the EU announced regulatory changes that could improve that situation. In addition, the CEO of PIP was sentenced to 4 years in prison by a French Court, and in January 2017, a French court demanded that the German regulatory company that had certified PIP implants as safe pay $60 million euros to women harmed by PIP implants. This is only 3,000 euros each to 20,000 women, however.
Meanwhile, the FDA shows no indication that they will improve their safeguards on breast implants or other medical implants; in fact, those safeguards have weakened since 2012.
For more information about ALCL caused by breast implants, see:
Miranda RN, Aladily TN, Prince HM, et al: Breast implant–associated anaplastic large-cell lymphoma: Long-term follow-up of 60 patients. J Clin Oncol 32:114-120, 2014.
Mazzucco, AE. Next Steps for Breast Implant-Associated Anaplastic Large-Cell Lymphoma. J Clin Oncol, 2014. Early Release publication. June 16, 2014.