Breast Implants and Illness: Confusion and Controversy

Despite not being officially recognized diagnostically, a quick search under “breast implant illness” in the National Institutes of Health National Library of Medicine PubMed database yields 126 peer-reviewed scientific journal entries, including studies and other forms of biomedical literature.

Breast implant illness symptoms can include autoimmune disorders such as rheumatoid arthritis and Sjogren's syndrome as well as nonspecific disorders such as fatigue, malaise, depression, chills, skin rashes, and fibromyalgia—among many others. 

As of September 2019 the FDA had received 64,580 adverse event reports regarding breast implants from patients and 446,084 adverse event reports from manufacturers as reported by Phoenix News | AZFamily.com. (These adverse event reports are not, however, specific to breast implant illness.)

In October 2019, the FDA recommended that black box warnings and other precautionary measures be taken to improve communication with patients regarding the “benefits and risks of breast implants.” Black box warnings are the agency’s strongest form of warning for consumers and are reserved for products with severe and life-altering side effects. Often black box warnings are the last regulatory measure that still allows a product to remain on the market.

In July 2019, breast implant manufacturer Allergan announced a worldwide voluntary recall of certain textured breast implants in response to an FDA request to recall the implants from the U.S. market.

In 1998, breast implant manufacturer Dow Corning agreed to pay $3.2 billion to settle claims from 170,000 women who alleged that breast implants made them ill, according to The Washington Post.

Why Are Diagnostic Codes So Important? 

Used around the world, ICD (International Classification of Diseases) codes are assigned to more than 70,000 diseases in order to help patients, health care professionals, and insurance providers identify conditions and the appropriate treatment and coverage. These codes help to maintain a uniform standard of care for all patients and are added to medical records. 

The World Health Organization manages the ICD, which is now in its 10th version (ICD-10) and receives annual updates between revisions. For example, new codes were added this year to track COVID-19 infections, exposures and screenings. In the U.S., ICD codes are overseen by the National Center for Health Statistics and Medicare and Medicaid services. 

Another important function of ICD codes is tracking. Understanding the scope of a condition is much less complicated when a universal code exists to identify it. Codes are used in clinical trials, gathering global health statistics-gathering efforts, and reporting causes of death. 

The CDC Responds: No Definitive Evidence for Breast Implant Illness

The ICD-10 Coordination and Maintenance Committee, composed of representatives of several federal health agencies, meets twice a year to review ICD code proposals. The Breast Implant Safety Alliance submitted proposals in both 2019 and 2020 and both times the proposals were deferred to a future meeting. After submitting a third time for the September 2020 committee meeting, BISA’s proposal was denied via email by a CDC representative. A new proposal, the representative stated, would not be warranted.

“Currently there is no specific criteria and the uncertainty still remains regarding the degree, if any, of association or causality, although some women say they experienced relief or improvement after removal, the level of evidence for causality is insufficient,” CDC Program Specialist Traci Ramirez emailed Towt on June 4 and Towt shared the exchange with MedTruth.

In light of the longstanding concerns over breast implant illness, Towt is shocked by this decision. 

Medtruth contacted Ramirez, who declined an interview but responded with an email containing the exact same statement she’d sent to BISA. 

“This topic was deferred until there is a definitive diagnosis. Currently the literature states that the term breast implant illness is an umbrella term that encompasses the manifestations, complications of breast implants,” Ramirez wrote in both emails.

Ramirez’s emails listed ICD codes already in existence that can be used for diagnosing breast implant-related issues like presence of breast implant, displacement of breast implant, deformity of reconstructed breast, and history of breast cancer, after issuing the following caveats: 

• “There is no definitive evidence that breast implant cause(d) the systemic symptoms.  
• Breast implant illness is a diagnosis of exclusion, after all symptoms have been worked up and ruled out.”  

Towt said that BISA’s detailed proposals included multiple medical studies linking breast implants to illness and cancer, as well as statements from physicians, including plastic surgeons, naturopathic doctors and nurse practitioners testifying to the reality and severity of this condition after treating patients with breast implant illness.

“Why won’t they give us a chance to (even) present our case?” Towt wonders.

The Call for a Standard of Care

BISA President and Founder Maria Gmitro believes a diagnostic code would enable all medical professionals, not just plastic surgeons, to better understand the symptoms of breast implant illness and develop a standard of care. This is crucial, as the majority of women experiencing symptoms typically don’t visit their plastic surgeon first. Instead they often seek to remedy a specific symptom by seeing a physician or specialist who might not be familiar with breast implant illness. A code could help health care providers connect the dots.

“It really is an injustice that you have women suffering, and it makes no sense that you can’t get them the help they need,” Gmitro told MedTruth.

Gmitro points to another struggle involving a harmful medical device targeting women, Essure. The Essure method of permanent birth control was taken off the market early this year thanks, in part, to a campaign led by health advocates and patients that revealed Essure’s serious dangers. Gmitro said that BISA’s been working closely with Essure patient safety advocates to shape  BISA’s own campaign for increased breast implant safety.

Rachel Brummert, FDA special government employee and consumer representative, sees similarities between these patient safety campaigns and her own personal advocacy. After becoming disabled from taking the fluoroquinolone antibiotic Levaquin in 2006, Brummert and a group of patient advocates urged the CDC and FDA to address Levaquin’s adverse side effects. This push led to the development of an ICD code for fluoroquinolone-associated disability in 2016.

When it comes to developing an ICD code for breast implant illness, Brummert doesn’t understand the delay. She was present as a consumer representative at the FDA’s 2019 breast implant hearing and feels these agencies aren’t taking patients seriously.

“I am with the FDA, but I also am a patient advocate and I think something’s going on here,” Brummert told MedTruth. “There is plenty of evidence as to the constellation of symptoms that would constitute breast implant illness. It’s there, they can’t speculate.”

“For the FDA, I would think that they would want as much information as possible. Then there’s at least the optics of wanting to help people. This is blatant ‘We know what we’re doing, and you don’t,” Brummert said regarding the FDA’s decline of BISA’s proposal. 

Issues with Insurance Coverage for Breast Implant Removal Surgery

According to the National Center for Health Research, insurance providers are legally required under the Women’s Health and Cancer Rights Act of 1998 to cover breast implant removal (explant) surgery after a mastectomy if the patient’s doctor believes the removal is “medically necessary.”

However, if the patient underwent augmentation of healthy breasts, some health insurance companies will only cover removal surgery if they believe it’s medically necessary — and patients, doctors and insurance companies don’t always agree on what this means. To insurers, “medically necessary” means the patient has experienced rupture, capsular contracture, persistent infection, chronic pain, or a diagnosis of breast implant-associated anaplastic large-cell lymphoma, according to the National Center for Health Research

Breast implant-associated anaplastic large-cell lymphoma, or BIA-ALCL,is a rare type of cancer linked specifically to textured breast implants.

While some insurers may cover costs associated with a condition arising from an elective procedure such as breast implants, most insurers will not unless they’re compelled to, illustrating the important role an ICD code can play in patients’ access to recovery.

An ICD code specific to breast implant illness would help patients file claims with their insurers to help cover the cost of removal surgery, which costs an average of  $2,641 — not including cost of operating room facilities, anesthesia or other related expenses — according to the American Society of Plastic Surgeons. A 2015 Health.com report estimates the cost of removal surgery at $4,000 and the cost of repeated MRI rupture screenings at $8,000 each time. 

Breast Implant Illness vs. BIA-ALCL

While BISA’s petition aims at providing clarity, one area still causing confusion around breast implant illness is that it’s often tied to BIA-ALCL. Anaplastic large-cell lymphoma has its own ICD code. 

Former FDA Analyst and Device Events Founder and CEO Madris Tomes believes this association muddies the waters for patients suffering from  breast implant illness. Without a code, patients still experiencing symptoms are often left behind when BIA-ALCL is ruled out as a diagnosis.

“There needs to be a separate ICD code to help explain what’s happening to the patients that don’t have lymphoma but definitely have many of the other symptoms that are included with breast implant illness,” Tomes told MedTruth.

Tomes said the next step will be getting in front of the right people who can enact change.