Our study reports that 96% of patients who underwent bilateral implant removal and total capsulectomies for BII-related symptoms reported improved or complete resolution of symptoms. The advantage of a total capsulectomy is that it prevents substances within the capsule such as silicone or biofilm from escaping into the body. By removing the scar tissue capsules and using drains, the risk that fluid will collect in the surgical site is reduced. Additionally, the implant should not be allowed to come into contact with normal tissue because it is still within the capsule during total capsulectomy. This prevents the recurrence of BII or other infection.
In our study the reconstruction was staged, allowing the breast to rest and contract and also allowing time for the return of culture results to institute appropriate treatment. Additionally, this gives patients more time to make an informed decision on reconstructive options. As the breast contracts and the inflammation decreases, the reconstruction becomes easier. On the other hand, some patients choose to undergo no further surgery. Nonetheless, there are reconstructive options such as mastopexy, breast reduction, fat grafting, or even a combination of fat grafting and mastopexy.
After surgical treatment, some of our BII patients wanted to replace their implants with new implants of a different type. This approach may improve BII symptoms but carries a greater risk that symptoms will return. This may be due to these patients being predisposed to reacting to breast implants and/or the biofilm. Both silicone and saline breast implant types are made from similar materials, and any foreign body can attract a biofilm or be contaminated. Biofilm formation around an implant can cause infections, capsular contracture, and other systemic symptoms.
A possible solution for future prevention of biofilms is to use multipurpose disinfection solution (MPS), similarly to the way contact lenses are cleaned. Fears et al. found that their novel MPS was rapid and effective at killing Acanthamoeba species in contact lens disinfection systems. Additionally, implant pocket irrigation seems to be an ideal way to prevent biofilms. In a survey assessing practices at preventing breast implant contamination, it was found that plastic surgeons used betadine (44%) and clorpactin (14%) to irrigate the breast pocket prior to inserting the implant. Another possible solution for biofilm prevention is to use antimicrobial solutions such as 10% povidone-iodine instead of saline.[8,9] Jewell et al. found that povidone-iodine was effective in killing gram-negative and gram-positive bacteria associated with biofilms that have been linked to capsular contracture.[8,9] Saline was not effective and may only be used for removing nonbacterial components such as fluids or blood.[8,9]
Use of a Keller funnel is suggestd to decrease the rate of capsular contracture. The Keller funnel is used to mechanically decrease bacterial contamination by limiting the implant's contact with the skin and ducts. In the same survey that was sent in Gowda et al.'s study, 69% of surgeons reported using a Keller funnel during breast reconstruction with breast implants. In a study conducted by Newman et al., when a Keller funnel was used, there was an 87% rate reduction in capsular contracture in patients having periareolar breast augmentation.
Propionibacterium acnes was the most common organism in our pathologic reports on patients' specimens. It is currently being studied to be associated with "rheumatological disorders, thyroid disease, sarcoidosis, endophthalmitis, and prostate disease."[11–13]Propionibacterium acnes has been found in the lymph nodes of patients suffering atherosclerosis, sarcoidosis, and discitis associated with sciatica. It is shown in both SAPHO (synovitis, acne, pustulosis, hyperostosis, and osteitis) syndrome and CREST (calcinosis, Raynaud's phenomenon, esophageal dysmotility, sclerodactyly, and telangiectasia) disease. Per-oral clarithromycin treatment of P. acnes in the lymph nodes of a sarcoidosis patient yielded disease resolution. This study raises the exciting prospect of possibly antibiotic treatment of BII or prevention with altered antibiotic prophylaxis regimes.
Earlier studies for infective etiology explored the possibility of commensal contaminants being a cause for disease.[15–17] Agents including anaerobic bacteria, fungi, and atypical organisms such as acid-fast bacilli were explored. These studies demonstrated colonization of implants and capsular tissue with S. epidermidis. Other organisms, such as Escherichia coli and P. acnes, were also noted.[15,17] The development of bacterial infection in the setting of the implant capsule may be supported by the finding that natural killer cell function is suppressed in the presence of a breast implant but is then reversed upon explantation.
How do we Diagnose BII and who may be at Risk?
There are no diagnostic tests or criteria for BII. Elevation in sedimentation rate and C-reactive protein are nonspecific markers found in some cases. Plastic surgeons who treat BII patients remark that it is common for those who seek treatment to have multiple symptoms that are interfering with their ability to function.[5,19–21] The common BII symptoms seen in this study were also seen in other similar studies. These symptoms included fatigue, cognitive problems, arthralgia, and ocular problems.[5,22] Many have gone to a number of other doctors before realizing that their symptoms may be connected to their implants. Alternative medicine physicians are treating an increasing number of these patients with nontraditional methods. Unfortunately, there is some charlatanism encountered by these patients.
We recommend that plastic surgeons rule out other causes of BII symptoms that are not related to the breast implants. This involves looking at test results (for inflammatory conditions) and determining whether any symptoms improved when the patient received treatment for other conditions. A patient may have BII and a diagnosed autoimmune disease. It is important to remember there is also a psychological component to this disease as well as a psychosocial aspect.[5,19–21]
Additionally, it can be particularly helpful after implant removal surgery for BII patients to eat a healthy diet, participate in regular exercise, and decrease stress. These steps will promote healing and decrease the inflammation in the body that can be associated with BII.[20,21]
BII may be caused by family genetics as well. For example, patients who have a personal or family history of autoimmune conditions, allergies, and irritable bowel syndrome may be susceptible to BII.[16,23] More importantly, there is no evidence that having a history of breast cancer or any other cancer makes a patient more likely to develop BII.[16,23–26] These findings tend to support these conclusions.
What Causes BII?
There is a lack of research on why some women with breast implants develop BII. One leading theory is that some people are predisposed to having an immune reaction to the breast implant material. This inflammation leads to symptoms such as joint and muscle pain, rashes, and gastrointestinal problems. Studies have shown that substances from breast implants (such as very small amounts of silicone and platinum) can "bleed" through an intact shell and into the surrounding tissue.[5,19–21] Substances from an implant can also spread within the capsule of scar tissue surrounding the implant or to other parts of the body due to a ruptured implant. There is a direct correlation between the duration of a breast implant in place and the likelihood of rupturing.
All women with breast implants are exposed to silicone due to the silicone shell. Based on our findings, biofilm contamination also plays a major role and may even be more prevalent than silicone sickness. It is possible that both contamination and silicone exposure in some people cause symptoms and disease.[5,21]
Studies have shown that BII symptoms may be secondary to chemical toxicity associated with implant materials and catalysts. Assertions have been raised about purported heavy metals, pathological organic compounds, and toxicity associated with industrial silicone in poly implant prothese devices.[12,27] Platinum is used as a cross-linking catalyst of silicone elastomers and present in silicone implant shells in microgram quantities. Neurotoxicity is not demonstrated in elemental platinum but rather in platinum-based chemotherapeutic agents. Lykissa et al claimed that the compound hexachloroplatinate was found in implants; however, repeated studies have failed to replicate this. Brook found that the quantity of platinum in implants is in the parts-per-million range, in the unoxidized form, making biologically reactivity unlikely. At the FDA's General and Plastic Surgery Devices Advisory Panel public meeting on breast implants in March 2019, an overview was given of scientific evidence that the silicone in breast implants can activate the immune system, resulting in inflammation and autoimmune problems.[5,20] Currently, the idea that the silicone in medical devices can affect the immune system is not widely accepted in medicine. The FDA announced in March 2019 that it is undertaking new efforts to evaluate the safety of medical device materials, including silicone. Other implants that are coated with silicone, such as pacemakers, may also develop biofilms. Further studies should be conducted to elicit the outcomes of silicone-containing implants and medical devices implanted in humans.
Emerging Research on BII
For the most part, the existing scientific literature does not show a definite connection between breast implants and autoimmune or connective tissue diseases and does not show that breast implants cause these conditions. A study conducted at University of Texas MD Anderson Cancer Center analyzed medical records of 100,000 women who had implants and were enrolled in long-term safety studies required by the FDA. The researchers found that women with silicone gel–filled implants were 6 to 8 times more likely to be diagnosed with Sjögren syndrome, scleroderma, and rheumatoid arthritis. However, there were some limitations in the study where some of the diseases were reported by patients. Outcomes were collected under more than 1 protocol, and a significant number of patients dropped out before the studies ended.
In addition, a team of researchers examined the electronic health records of 123,255 Israeli women (24,651 had silicone gel–filled breast implants and the rest did not have breast implants). The records contained up to 20 years of data. The researchers found that the women with silicone gel–filled breast implants were significantly more likely to be diagnosed with autoimmune or rheumatic disorders, such as Sjögren syndrome, systemic sclerosis, and sarcoidosis, compared with women without breast implants of a similar age and socioeconomic status.
Finally, there have been studies that show a substantial number of BII patients do not experience symptom improvement after explantation. More studies are needed to prove these associated theories.
What Should Patients do if They Think They Have BII?
A patient that is considering getting breast implants for the first time or replacing ones that they already have should discuss with their plastic surgeon the possibility of having a potential risk factor for BII. Prior to every breast implant placed, patients should have a thorough informed consent discussion with the plastic surgeon. An autologous reconstruction is recommended for patients who have risk factors.
Patients should consider replacing breast implants every 10–15 years; if patients start to develop symptoms of BII, they should not have implants replaced once the old implants are removed.
If a patient thinks they have BII, they should seek out a board-certified plastic surgeon who has experience treating BII patients and is not dismissive about the symptoms the patient is experiencing. It should not be assumed that the surgeon who placed the implants is the surgeon that should remove them.
Private health insurance plans cover surgery to remove breast implants in women who have had a mastectomy and breast reconstruction. Because BII has no diagnosis code, plastic surgeons should record patient symptoms such as breast pain, rupture of implant, and shortness of breath to show the insurance company that surgery is necessary. This prevents paying out of pocket for implant removal.
Although this study adds some validity to the concept of BII, further studies should be conducted through the Plastic Surgery Foundation's National Breast Implant Registry (NBIR).
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