Defining Breast Implant Illness: Patient-Reported Outcomes after Breast Explantation

Presented by Corinne Wee, MD

On Friday, Sept. 20, Corinne Wee, MD, started her presentation by referring to known complications of breast implants. Dr. Wee, a third-year plastic surgery resident at University Hospitals Cleveland Medical Center, outlined the standard preoperative counseling, which includes informing patients of complications like bleeding, poor scarring and wrinkling of skin over the implant.

She also referenced the largest research study of breast implant outcomes, conducted by MD Anderson, which found silicone implants are associated with higher rates of Sjögren's syndrome, scleroderma, rheumatoid arthritis and more.

Standard Preoperative Complication Counseling

  • Bleeding
  • Hematoma
  • Infection
  • Altered nipple sensation
  • Poor scarring
  • Poor position of implant
  • Capsular contracture
  • Seroma
  • Persistent pain
  • Risk of revision
  • Wrinkling of skin over implant

The research presented by Dr. Wee, which is spearheaded by senior author Dr. Feng at the Lu-Jean Feng Clinic in Cleveland, Ohio, focuses on the complications that aren’t as frequently discussed.

Breast implant illness, described as a constellation of symptoms, is a controversial topic, Dr. Wee said. Dr. Wee, who became involved with data collection in 2018, was part of the independent team of collaborators at University Hospitals. The purpose of the study was to evaluate the prevalence of symptoms for women seeking explant, identify how the symptoms changed before and after total capsulectomy, and better understand which patients would benefit most from explant.

During a retrospective study beginning in 2017, the researchers gathered data from 741 patients and examined 11 common symptoms of breast implant illness using a patient assessment. Participants rated each symptom from zero (absent) to five (severe) before and after total capsulectomy performed by Dr. Feng at The Lu-Jean Feng Clinic. 

Patient Symptoms and Severity 

  • Numbness and/or tingling in the extremities 
  • Joint and 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 

The study revealed  improvement in certain combinations of symptoms upon complete removal of breast implants and scar capsules surrounding the implants, according to an email from Dr. Feng. 

“In other words, simply removing the implants and not the capsules did not produce the same significant improvement in health,” Dr. Feng wrote. 

Patient symptom severity saw a statistically significant improvement: on a scale of 0 (all symptoms absent) to 55 (all symptoms severe), the severity score dropped from an average of 26.4 to an average of 9.0. Patients were followed for 200 days, and the results indicated a dramatic improvement maintained over time, Dr. Feng wrote.  Patient factors, such as body mass index, could affect the level of improvement. 

The patient population came from every state in the U.S. and more than 39 countries around the world. However, the study does not represent the population of all implant recipients. The frequency of breast implant illness cannot be estimated in any unbiased population, Dr. Feng wrote. 

When the floor was opened for questions, there were doubts about the research. A surgeon in the audience asked about population controls, sham symptoms and the cause and effect placebo. In response, Dr. Wee acknowledged the study has not yet been validated. 

The researchers will follow patients for a longer term. Additionally, researchers will be pinpointing specific symptoms and working on an additional study focusing on difficulty breathing.

A Focus on Facts: What the Science Tells Us About BIA-ALCL & BII

Moderated by Jeffery Janis, MD

Hundreds of plastic surgeons filled the ballroom on Saturday, Sept. 21 for a long-awaited panel on BIA-ALCL. The panel, moderated by Jeffrey Janis, MD, included eight speakers from different backgrounds.

MD, FDA

MD

Former Paramedic, BIVA Founder

MD, FACS

MD

MD

MD, MHS, FACS, FRCSC

MD

The Food and Drug Administration (FDA)

The BIA-ALCL panel began with video clips recorded at the U.S. FDA Advisory Committee Hearing on Breast Implants, which took place in March 2019. The video featured testimony from Terri McGregor, a breast implant safety advocate, who was present at the conference. She spoke of her agonizing experience with BIA-ALCL, referred to other harmed patients and asked the FDA to withdraw all textured implants from the market.

Dr. Binita Ashar, director of the F.D.A.’s Office of Surgical and Infection Control Devices, spoke after the video, presenting on the history of breast implant regulation. She described a long and complicated regulatory record,acknowledging difficulties with post-approval studies and an uptick in adverse events from 2011 to 2019. 

In her statement, Dr. Ashar said the FDA’s goal is to work collaboratively with surgeons, patients and manufacturers to better understand breast implant complications. She said the agency is currently learning how to test for BIA-ALCL.

The Plastic Surgery Foundation (PSF)

Andrea Pusic, MD, president of the Plastic Surgery Foundation (PSF), presented on the importance of submitting information to the registry on breast implant illness. The American Society of Plastic Surgeons (ASPS) has created a task force on Women’s Health and Breast Devices, asking surgeons to contribute to the National Breast Implant Registry (NBIR) to improve post-market surveillance in tracking all operations and reoperations in the U.S.

“This work is moving forward very rapidly,” Pusic said. 

In 2020, the goal is to devise  additional research grants to fund  breast implant safety studies. Pusic is working on coverage and care for adverse effects, and she requested for NBIR membership to double following the event.

Breast Implant Victim Advocacy (BIVA)

Jamee Cook, a former paramedic and a patient advocate who founded BIVA, spoke of her experience with an undefined illness. After removing her breast implants, she went from suffering and symptomatic to finding relief that made her certain the implants were the culprit. She founded BIVA on Facebook in 2016 to create a community of women who could share similar experiences.

As a Facebook page for patient support, BIVA grew to 8,000 members. Cook has a direct line to thousands of patients, and she’s calling for a rational discussion focused on finding common ground and moving forward. 

“There is crucial data that is missing from study information,” Cook said.

Audience Questions & Answers

The  moderator opened the floor for questions, and plastic surgeons, implant manufacturers and advocates took to the microphones. The audience response was mixed, but concerns for patient safety were present. Potential conflicts of interest may have also played a role.

“What should we tell our patients?” An anonymous surgeon asked the panel. 

“Exposure to any textured implant is a risk,” Dr. Scot Glasbeg, former president of ASPS, said. “I can’t say that it’s zero.”

“What about smooth implants?” Another surgeon asked. 

“It’s ill-advised to inform patients that they are risk-free with smooth implants, as we just don’t know,” Dr. Ashar said.

A mention of patient hysteria turned the conversation, exploring the concept that patients may seek unnecessary explant. On the topic of not informing smooth implant patients of a potential risk, a woman raised her hand and objected.

“To withhold that information is irresponsible and unethical,” said Karuna Jagger, executive director of Breast Cancer Action, a grassroots education and activism organization for getting real about breast cancer.  “I would urge you to disclose all possible risks to patients.”

“These patients are real,” Cook said.

“The only way we can learn more is to get data,” Dr. Glasberg said. The call to action stands.

Breast Implant Safety Takeaways

Breast implants are not lifetime devices. Breast implants, regardless of texture grading and saline or silicone gel, age over time. Aging affects the implant and increases the risk of a gel bleed, which occurs when microscopic gel from inside the implant leaks into the body. 

Breast implant illness and BIA-ALCL are two separate diseases. There are potentially tens of thousands of cases of undiagnosed breast implant illness, an unofficial condition made up of various symptoms. Currently, there are 573 confirmed cases of BIA-ALCL, which is a man-made lymphatic cancer. 

Complications for patients with aesthetic and reconstructive breast implants differ. Textured implants may be more common in reconstruction patients who have injured tissue from a mastectomy. Additionally, patients who received breast implants for reconstruction may be more likely to have surgical mesh. 

Textured breast implants and smooth breast implants come with distinct challenges. The texturing on breast implants can flake off and create a thicker capsule or a double capsule around the implant. There have been no cases of BIA-ALCL linked to smooth implants. 

Footnotes

‘US FDA Breast Implant Postapproval Studies: Long-term Outcomes in 99,993 Patients.’ January 2019. Department of Plastic Surgery, MD Anderson Cancer Center, Houston, TX