Saturday, 30 September 2017

#ClinicSpeak & #ResearchSpeak: breast implants not associated with multiple sclerosis

Silicone breast implants not associated with a higher incidence of autoimmunity. #ClinicSpeak #ResearchSpeak

Summary: A large study in over 55,000 women undergoing breast augmentation with saline and silicone implants demonstrates that breast implants are not associated with a higher risk of developing MS. 

Theoretical ClinicSpeak scenario: A patient with MS asked me to write a letter to her plastic surgeon about her planned breast augmentation surgery. Her surgeon was reluctant to do the surgery on the off chance that it would make her MS worse. I dutifully wrote the letter stating that to the best of my knowledge I was not aware of any reason why she shouldn't undergo the surgery because of her MS. 


Interestingly, a few years ago there was a crisis about the possibility of silicone breast implants triggering, or causing, autoimmunity. This was thought to relate to ruptured silicone implants. Therefore the large study below is reassuring that both silicone and saline breast implants are not associated with a higher incidence of multiple sclerosis if anything the risk was lower. 


Singh et al. Five-Year Safety Data for More than 55,000 Subjects following Breast Implantation: Comparison of Rare Adverse Event Rates with Silicone Implants versus National Norms and Saline Implants. Plast Reconstr Surg. 2017 Oct;140(4):666-679. 


BACKGROUND: The U.S. Food and Drug Administration has required postapproval studies of silicone breast implants to evaluate the incidence of rare adverse events over 10 years after implantation.

METHODS: The Breast Implant Follow-Up Study is a large 10-year study (>1000 U.S. sites) evaluating long-term safety following primary augmentation, revision-augmentation, primary reconstruction, or revision-reconstruction with Natrelle round silicone breast implants compared with national norms and outcomes with saline implants. Targeted adverse events in subjects followed for 5 to 8 years included connective tissue diseases, neurologic diseases, cancer, and suicide.

RESULTS: The safety population comprised 55,279 women (primary augmentation, n = 42,873; revision-augmentation, n = 6837; primary reconstruction, n = 4828; and revision-reconstruction, n = 741). No targeted adverse events occurred at significantly greater rates in silicone implant groups versus national norms across all indications. The standardized incidence rate (observed/national norm) for all indications combined was 1.4 for cervical/vulvar cancer, 0.8 for brain cancer, 0.3 for multiple sclerosis, and 0.1 for lupus/lupus-like syndrome. Silicone implants did not significantly increase the risk for any targeted adverse events compared with saline implants. The risk of death was similar with silicone versus saline implants across all indications. The suicide rate (10.6 events per 100,000 person-years) was not significantly higher than the national norm. No implant-related deaths occurred.


CONCLUSIONS: Results from 5 to 8 years of follow-up for a large number of subjects confirmed the safety of Natrelle round silicone implants, with no increased risk of systemic disease or suicide versus national norms or saline implants.

13 comments:

  1. Why is the patients confidential data being written on here for this is not good that you have no confidentiality towards .

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    Replies
    1. What is confidential here? How do you identify the person....a boob inspection? Furthermore it could be a transexual, so does have to be a biological woman. Also the story line could be made up to make a point
      the post is aimed to pass on the information in an ms relevant manner.

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    2. MD is right this post does not refer to a specific patient, but a general scenario. When I was at school we called it poetic license; i.e. the freedom to depart from the facts of a matter when writing in order to create an effect.

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  2. https://www.scie.org.uk/care-act-2014/safeguarding-adults/sharing-information/what-does-the-law-say.asp

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  3. Yo, yo, yo, homies!

    I'm b-b-b-ack. I have been UK bound for a month having been resident in Saudi Arabia this summer. I met an Arab dude with MS out there. All that sunshine yet he still got ill. I was about to navigate him to this blog but didn't wanna waste his time. Jesus, imagine if he'd have clicked this post? He'd get locked up.

    I was browsing old posts and saw that Don Giovannoni is haemorrhaging readership, and now he is enrolling in creative writing lessons to improve cyber footfall. Don't bother, mate. This blog is incapable of change. Its layout is old and dull. It is as if 2005 never ended. Get the painters and decorators in, son. Spruce the joint up.

    Also, feel free to welcome me home. I missed you all.

    ReplyDelete
    Replies
    1. We're so excited that you're back.... and from such a nice place too

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    2. Oh welcome back Dre, particularly after iaino well and truly owned you after your last visit on the Brexit/MS piece. I'm still smiling ;-)

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  4. But the question is does having breast implants in any way contribute to increased MS activity? Rather than developing MS.

    I wonder if the stress of any major operation or risk of infection might be something to consider?

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  5. Am trying to up my comments game, all day I have been holding off! Someone else do a boob joke please!

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  6. "a boob inspection? "LOLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLLL

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  7. What about butt, or penis, augmentation?

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    Replies
    1. Same principle; unlikely to impact on MS. But male sexual dysfunction is very common in MS and a penis implant is unlikely to correct the problem.

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