Capsular Inflammation Linked to Silicone and Textured Implants 

Louise Gagnon

September 17, 2021

A recently published study in Plastic and Reconstructive Surgery Global Open suggests that patients who presented with breast implant illness (BII) — a term first coined in social media to refer to systemic symptoms developing after breast augmentation surgery — showed capsular inflammation that was significantly linked to silicone implants and textured implants.

"This has become a hot topic in plastic surgery over the last 2 years," said Jacob Katsnelson, MD, the paper's leading author and a fifth-year surgery resident at Abington Memorial Hospital, Abington, Pennsylvania, in an interview with Medscape Medical News. "No one has been able to show a clear association between a specific type of implant and development of the symptoms or a specific explanation for why an implant would cause symptoms like this."

Katsnelson noted that BII is discussed on social media channels, with one Facebook group called Healing Breast Implant Illness having more than 100,000 followers. The most common symptoms reported by women who self-diagnose BII include generalized pain, fatigue, cognitive "fogginess," migraines, headaches, anxiety, arthritis, vision changes, dyspnea, hair loss, weight gain, back pain, rashes, generalized gastrointestinal issues, and depression, said Katsnelson, noting women attribute the symptoms to their breast implants.

Of the 248 women included in the retrospective study, 111 capsules (23%) showed inflammatory changes on permanent pathology. Investigators found that capsular inflammation was independently linked to silicone compared to saline implants (right odds ratio, 2.18; 95% CI, 1.16 - 4.11; P = .016; left OR, 2.35; 95% CI, 1.08 - 5.12; P = .03). They also found an independent link between capsular inflammation and textured compared with smooth implants (right OR, 2.18; 95% CI, 1.16 - 4.11; P = .016; left OR, 2.25; 95% CI, 1.17 – 4.31; P = .01).

"The majority of patients did not have inflammatory changes [of capsules] on pathology," said Katsnelson, noting less than one quarter of study patients had such changes. "The data on inflammation suggests a proportion of patients had an association with a type of implant in terms of their symptoms, but the jury is still out as to what the underlying pathophysiology is [of BII]."

In terms of complications in removal of the implants, 6 of 248 (2.4%) patients had a major complication defined as pneumothorax, hematoma requiring evacuation, or deep vein thrombosis. 8 of 248 patients had minor complications such as seroma, liquefied hematoma, or wound infection. Of 228 patients, 206 (90.4%) reported high satisfaction with the outcome of the procedure. Fourteen patients had positive cultures, with the most common organism being Staphlyococcus.

As these data are retrospective, Katsnelson plans to conduct a prospective investigation to determine what symptoms patients present with and to see if they have resolution of their symptoms after removal of implants.

William P. Adams Jr, MD, president of the Aesthetic Society and a plastic surgeon practicing in Dallas, Texas, was critical of the research, pointing out BII is not a recognized medical condition. "Breast implant illness is a term of social media," said Adams. "It's not a defined disease. Although we recognize patients have symptoms, we don't have any science to say that breast implant illness is something that's directly caused by breast implants."

Adams stressed that Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL) is a defined entity whereas BII is an ill-defined, unknown entity.

The results of the study should be called into question, according to Adams. "You can make no significant conclusions based on the findings of the study," he said, noting a weakness of the study is that there was no control group for comparison.

The study findings with respect to inflammation are not novel and not suggestive of illness, explained Adams. "Inflammation is a normal response in capsular development. How capsules develop is a typical wound-healing inflammatory process."

In terms of the culture results of the study, Adams said it is expected that bacteria would be found with certain implants.

And he added that if patients report symptom improvement following breast implant removal, this could be also attributed to a placebo effect. "The reason that they get better is not necessarily because of the implant no longer being present," he said.

More rigorous study, funded by The Aesthetic Surgery Education and Research Foundation, is on the way and is needed to understand the systemic symptoms that patients are reporting; the role of implants and capsules with respect to the symptoms; and if management that includes implant removal and capsulectomy leads to symptom improvement, according to Adams.

Katsnelson and Adams have disclosed no relevant financial relationships.

Plast Reconstr Surg Glob Open. Published online September 7, 2021. Full text

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