Approximately 219,000 women had their breast implants removed in 2021 and about a third chose not to have them replaced, according to industry estimates.
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Because implants are not meant to last a lifetime, they may often require replacement; about every 10 to 15 years, according to many reports. However, the latest data suggests more and more women are choosing not to replace their implants following removal. The number is up 47% in 2021 over 2020 compared to a 32% increase in those who removed and replaced their implants that year.
These national statistics come as no surprise to Martin Newman, MD, Department Chair of Plastic and Reconstructive Surgery at Cleveland Clinic Florida.
“I’ve seen a substantial increase in implant removal in recent years, with and without replacement and for a variety of reasons,” he says. “From capsular contracture, rupture and malposition to aging, changes in weight, changes in styles, and pregnancies. Many factors motivate patients and for some that includes the fear of breast implant illness.”
Breast implant illness (BII) is a collection of symptoms that occur in people with breast implants. More than 100 symptoms have been associated with BII, including fatigue, joint pain, brain fog, rash and many others. They can occur with any type of breast implant, both shortly after implantation and even years later.
In October 2021, the U.S. Food and Drug Administration (FDA) issued guidelines requiring breast implant manufacturers to include box warnings on packaging to inform patients about the risk of systemic symptoms as well as in a patient decision checklist.
“There isn’t an official medical diagnosis for BII, and there is much we don’t know about the condition,” admits Dr. Newman. “This information gap is part of the reason I’m having so many conversations about implant removal with both patients and colleagues.”
In addition to BII, breast implants also have been associated with certain forms of cancer in a small number of patients, creating added concern about implant safety. Breast implant-associated anaplastic large-cell lymphoma (BIA-ALCL), for example, is a rare immune system cancer that develops in the fibrous periprosthetic capsule adjacent to breast implants. It is largely associated with textured breast implants but has also been reported with smooth implants.
“Breast swelling is a classic presentation of this cancer, though other symptoms may include pain, lumps, rashes and breast asymmetry,” says Dr. Newman. “It’s important to understand, however, it is not a breast cancer.”
In July 2019, one implant manufacturer issued a voluntary recall of its textured breast implants and tissue expanders as a result of the complication. While the recall letter called for any product on the shelf to be returned, it did not specify removal of those already implanted.
“I definitely saw an increase in patients who wanted to remove their textured implants on the heels of the recall though the FDA does not recommend having implants removed unless patients are experiencing symptoms,” says Dr. Newman. “I’ve also seen ALCL in my practice and engaged the national registry responsible for tracking cases.”
The PROFILE Registry (Patient Registry and Outcomes for Breast Implants and Anaplastic Large Cell Lymphoma Etiology and Epidemiology) was established in 2011 and expanded in March of this year to also include patients who have a suspected or confirmed case of breast-implant associated squamous cell carcinoma (BIA-SCC) or any lymphoma or other cancer found in the capsule surrounding a breast implant.
“Like ALCL, BIA-SCC appears to emanate from the breast implant capsule and can spread to lymph nodes, local tissues and distant sites,” explains Dr. Newman. “It has been associated with both smooth and textured implants.”
According to the American Society of Plastic Surgeons, 80% of the 19 reported BIA-SCC cases presented with spread beyond the capsule compared to just 28% of the 1,400 BIA-ALCL cases reported worldwide.
With greater public awareness of breast implant illness and implant-associated cancers, Dr. Newman worries some patients may seek breast implant removal based on misinformation and fear. He also hears concerns from colleagues in primary care who are encountering patients with generalized symptoms who leap to conclusions before being evaluated.
“When patients come to me requesting implant removal, my first step is to define their concern,” he says. “Are they experiencing symptoms, is it anxiety about the potential for harm, or is it simply a personal preference? How they respond will guide the conversation.”
Dr. Newman notes even among patients with breast implants who are not seeking removal, there is a near universal question: “When do I need to change my breast implants?”
“Unfortunately, there is no hard, fast answer to this question as every patient is unique,” he explains. “I will say, if there is ever a question about breast implant integrity, it can be easily assessed with imaging and should be performed according to FDA guidelines or if symptoms arise.”
For patients with self-reported BII symptoms, Dr. Newman says, “First and foremost, they should be up to date on their mammograms.”
Once a patient is cleared from a breast cancer diagnosis, then it’s necessary to rule out other potential underlying causes. “Breast implant illness is a diagnosis of exclusion because many systemic symptoms may be similar to other conditions, including autoimmune diseases, fibromyalgia, hypothyroidism, and even menopause,” he explains.
This may entail referral to an appropriate specialist depending on the patient’s symptoms, whether they be in neurology, dermatology, rheumatology, endocrinology, or other specialty. “If no underlying conditions are found, patients can then be referred to a board-certified plastic surgeon,” advises Dr. Newman, noting some patients actually experience immediate symptom improvement following implant removal.
Meanwhile, patients with late-onset, peri-implant changes, including delayed seroma, unilateral swelling and pain, should undergo image-guided fine needle aspiration (FNA) of periprosthetic fluid and cytology testing as well as imaging studies, according to ASPS/PSF recommendations. Though Dr. Newman notes that sometimes it is not possible to sample the fluid in this manner.
If diagnosed with BIA-ALCL or BIA-SCC, the patient should be referred to a plastic surgeon familiar with the diagnosis and treatment of these diseases.
Once a patient is ready to move forward with breast implant removal, there are three main options: definitive removal; removal and replacement; or definitive removal followed by a breast lift (mastopexy). Some patients elect to combine two of these options – replacement and breast lift.
“There are some patients who will choose to simply have their implants removed with no further intervention,” says Dr. Newman. “In my experience, however, the most popular option in our patient population is to follow implant removal with a breast lift to remove excess skin and reshape the breast tissue for better cosmesis.”
Removal followed by replacement is also commonly seen in patients with “older,” textured or ruptured breast implants, according to Dr. Newman.
“Among my patients who have had breast reconstruction following breast cancer, some also choose to remove their implants completely and have natural tissue reconstruction,” he says. “While others with large implants want a smaller implant and a modified lift for a more natural look.”
Most importantly, says Dr. Newman, it is imperative that any patient considering breast implants for the first time or looking to replace their existing implants should be fully informed of the benefits and risks of implants and provided the FDA-required educational materials to make an informed decision.
