H Jae Chun MD

PART2

This is where the wild west of data manipulation can take place.
If you wanted to show how "safe "these implants are, one can claim only 81 patients with surgically confirmed rupture out of 1008 patients and thus the rupture rate of 0.8% at 10 years.
If you wanted to exaggerate the rupture risk, one can claim 120 patients with abnormal MRI(equals "rupture" in this study) out of 467 patients(46% of 1008 patients with available data) and thus the rupture rate of 26% at 10 years.

So the rupture rate can vary between 0.8% -26% at 10 years depending on how the data is manipulated.

Typically most surgeons based on other studies claim around 10-15% at 10 years.

In my practice, I know the age, brand, and the rupture status of every implant I take out.
My own data of patients with silicone implants up to 13 years old showed a patient rupture rate of 11% with no difference between Mentor and Allergan.

A recent 2022 article published by Dr Salzman demonstrated a 7.2% rupture rate at 10 years using High-Resolution Ultrasound.

So in conclusion, almost all the available data suggests around 7-15 % rupture rate at 10 years with most of the ruptures taking place between 7-10 years.
This emphasizes the need for constant MRI/US evaluation and the need to remove silicone implants before they get "too old"/rupture.

My data and all the other published data suggest the 24% rupture rate quoted in this article is an outlier.

PART 1

I like to thank .muller1010 for bringing this article to my attention. I missed this article.

But a couple of clarifications are necessary. This was not the Core Study but rather a final follow-up of Mentor's silicone gel Core study data.
There never was a "Siltex Core Study" as .muller1010 referred to, since the term Siltex refers to Mentor textured implants but this core study was about both smooth and textured gel implants.

As usual, the devil is in the details. This article clearly demonstrates how a study data can be manipulated to support whatever claims desired.
Let me explain by first summarizing the study for everyone.

In the publication of the original Mentor Core study, the rupture rate at 3 years(that's all the data they had) was 1.4%.
BTW, this 3-year data, which in my opinion, was inadequately short was used to convince the FDA to approve silicone gel implants in 2006.
The article she refers to was published by Dr Caplin in 2021 and reported on the 10-year follow-up data of the original Core Study patients.

The Core Study enrolled 1008 patients and followed them for 10 years but they only had follow-up data on 46% of the originally enrolled patients.
At some point, all patients were asked to get an MRI evaluation but not every patient complied, and remember 54% of patients were lost to follow-up.
Of the unknown number of patients that had MRI, 120 patients(representing 145 implants) showed "rupture".
But this article included any suspicious finding as a "rupture" even if one of the two involved radiologists disagreed.
ONLY 81 out of these 120 patients chose to have their ruptured implant removed.
This is highly unusual as most patients with MRI diagnosis of rupture want their implants removed ASAP so could this indicate some degree of uncertainty about the MRI diagnosis?
But these patients who did not have their "ruptured" implant removed were also counted in the "rupture"

This article was just published in PRS which is the official journal of the American Society of Plastic Surgeons.
It is a report out of Japan with 3 patients with breast implants presenting with what we(supposedly uneducated social media crowd and me, a charlatan) have long known as BII but the “experts” like to assign all kinds of other acronyms. 2/3 patients had their implants and capsules removed after not responding to medications initially and improved dramatically. Again we have seen this time and again but for some reason these cases are viewed as unusual cases deserving of case reports. The third patient never received surgery and did poorly. The authors concluded that proper surgery should be considered in these cases. Again to us in BII community, an old news. The most significant aspect of this article was that it was published in PRS, the official journal of the American Society of Plastic Surgeons. Slowly the truth is seeping into the main stream Plastic Surgery.

https://doi.org/10.1093/asj/sjae113

This article was accepted for publication in ASJ which is the official cosmetic surgery journal of the Aesthetic Society. Reviewing cases of 614 Israeli women over 10 years, the authors found the presence of silicone in the axillary lymph nodes in 13.6% of women with silicone breast implants. The incidence rose with older(more likely to be ruptured) implants. Also curiously with Mentor and PIP implants. Typically polyurethane coated implants can cause silicone migration into lymph nodes. It was not mentioned whether these 2 brands in Israel carried polyurethane models. Although seen with 59.4% of ruptured implants, intact silicone implants were still associated with 17.7% incidence which is deeply concerning.

For years, so many women complaining of silicone migration into areas away from breasts were labeled as “crazy”. Even now most plastic surgeons will dismiss the possibility of silicone migration as “nonsense” promoted only by “self-serving, snake oil selling, unethical, and incompetent” few plastic surgeons who can’t do anything else and “crazy and hysterical” BII patients manipulated by social media nonsense.

And yet, here it is. An article about to be published in their official journal, clearly showing what we in BiI community have known for years.

Truth always emerges, eventually.

As many of you know, I am currently out on medical leave. I have heard all the crazy rumors. I am reminded of a lyrical verse “talk is cheap when the story is good”. Nothing salacious or serious but just lot of wear and tear issues from doing so many surgeries over my 35-year surgical career.

Many have inquired about what I am doing currently other than resting and rehabbing. Whether I am still involved with the BII movement and advocating the correct explant surgery. The answer is a resounding “yes”.

I have taken this opportunity to increase awareness within the plastic surgery community about misperceptions about BII and explant surgery that are so pervasive and blatant. Many patients have asked why I don’t spend more time educating other plastic surgeons on how to correctly perform this surgery. The reality is that most plastic surgeons are highly trained and skilled, more than capable of performing these surgeries. It’s not “ don’t know how to” but rather “don’t want to “ issue because of these misperceptions. If these misperceptions are not called out and corrected, there will be no progress in my opinion.

So I will be speaking this weekend at the Los Angeles Society of Plastic Surgery and also in December at the Florida Plastic Surgery Society. Some in the audience will be curious, some are hoping for a crash and burn while others will consider a waste of time on “lot of nonsense “. But as I always say, Rome wasn’t built overnight.

En-bloc total capsulectomy and removal of intact submuscular textured Allergan saline implants. 6/14/2023.

En-bloc total capsulectomy and removal of intact submuscular silicone implants. 6/14/2023. Focal area of thickened capsule, corresponding to the area of previous surgical deep incision. This happens occasionally.

Total capsulectomy and removal of intact submuscular silicone implants. Extremely challenging case due to very friable and stuck capsules extending all the way up to clavicle. 6/13/2023.

En-bloc total capsulectomy and removal of intact submuscular silicone implants used to reconstruct after mastectomy. Also removed previously placed dermal matrix product which can be clearly seen on the inner capsular lining. There was also a right breast mass which will probably turn out to be a lymph node filled with tattoo ink. Submitted for pathology. 6/13/2023.

Total capsulectomy and removal of intact subglandular silicone implants. She had her initial breast augmentation in 1995 with saline implants in the submuscular position. In 1997, these were replaced with subglandular saline implants(pocket change). More recently replaced with silicone implants. So these residual submuscular capsules were only 2 years old when the pocket changed occurred 25 years ago. Even after 25 years, these thin capsules are still there. Yet, many PS still claim old capsules go away/dissolve with time.
Time and again I encounter and remove these residual capsules that were “supposed “ to dissolve. 6/8/2023.

Total capsulectomy and removal of intact submuscular saline implants. Thin capsules with early calcifications on the right implant. 6/8/2023.

En-bloc total capsulectomy and removal of intact silicone implants. Also removed previously placed Alloderm (cadaver skin). 6/7/2023.

Total capsulectomy and removal of intact submuscular silicone implants with thin capsules. 6/6/2023.

En-bloc total capsulectomy and removal of intact submuscular silicone implants. 6/6/2023.

Total capsulectomy and removal of intact submuscular silicone implants. 6/1/2023.

Total capsulectomy and removal of intact submuscular saline implants. 5/31/2023.

En-bloc total capsulectomy and removal of intact submuscular silicone implants. 5/31/2023.

En-bloc total capsulectomy and removal of intact submuscular textured saline implants. 5/30/2023.

En-bloc total capsulectomy and removal of intact submuscular saline implants. 5/30/2023.

Total capsulectomy and removal of intact textured Allergan silicone implants. 5/25/2023.

Total capsulectomy and removal of intact submuscular silicone implants. These were previously placed through armpit incisions which usually means capsules extending into the armpits. Also very thin and had to be peeled off of the Thoracoacromial blood vessels. Difficult case. 5/25/2023.

Total capsulectomy and removal of intact submuscular saline implants. Very thin capsules. 5/24/2023.

En-bloc total capsulectomy and removal of intact submuscular saline implants. 5/24/2023.

En-bloc total capsulectomy and removal of bilaterally ruptured 12 years old Mentor submuscular silicone implants.Probably more recent ruptures as there weren’t that much free silicone gel on the implant surfaces. En-bloc removed ruptured silicone implants without spilling free silicone gel. There was no indication that these were ruptured other than the age of implants at 12 years. Once again demonstrating that en-bloc whenever possible often saves the day. 5/23/2023.

En-bloc total capsulectomy and removal of intact submuscular silicone implants with severe capsular contracture causing hardness, deformity and pain. Abnormal bunched up shape of implant capsule complex is caused by thick capsule squeezing the underlying implant. 5/23/2023.

En-bloc total capsulectomy and removal of ruptured(right implant)13 years old Allergan submuscular silicone implants. Detected by preop MRI. En-bloc prevented free silicone gel spillage. 5/17/2023.

En-bloc total capsulectomy and removal of ruptured 35 years old submuscular silicone implants. Thin capsules stuck to the rib cage and extending very high up near clavicles made this an extremely challenging case because it had to be done en-bloc in order to prevent free silicone gel spillage. There’s a Facebook live video at H Jae Chun MD. 5/17/2023.

En-bloc total capsulectomy and removal of intact submuscular saline implants. 5/16/2023. Thin capsules.

Removal of bilateral residual capsules after incomplete capsulectomy in 2019 due to BII. Also had fat injection at that time. Persistent BII symptoms and an ultrasound showing a right breast mass led to this surgery. Right breast mass represents fat injected inadvertently into the right residual capsule. Since there is no blood flow inside the capsule, fat died(fat necrosis) and turned into yellow paste. Another case demonstrating that old capsules never dissolve and disappear. There’s a Facebook live video at H Jae Chun MD page. 5/16/2023.