People have been calling my office a lot recently, concerned about their implants, and “all the stuff they are reading in the news.” Bear with me for this long blog, and I am happy to see you anytime if you want to come in for check up, but please read away.
BREATHE.
For my patients none of this is new, almost none of you have textured implants (I use them as rarely as I see double rainbows, and if you have a textured implant it is because you have the style 410 shaped implant and you would know that), and implant related inflammation isn’t so common (particularly since 2011 when I discovered biofilm and really changed a bunch of things I did for breast augmentation.) If you are not my patient, I don’t know about other doctors out there. I am a board certified plastic surgeon, I really read a ton and use science to guide my advice and techniques, I operate in a certified center, I did a breast fellowship, and other things. So I am not talking to the world population of breast implant patients, because I don’t know what your doctors do.
Implants have been in the news recently.
- FDA announcement March 19, 2019 “FDA issues warning letters to two breast implant manufacturers for failure to comply with post-approval study requirements” The FDA issued warning letters to Mentor Worldwide LLC of Irvine, California, and Sientra, Inc. of Santa Barbara, California. Every manufacturer of approved silicone gel-filled breast implants is required to conduct post-approval studies to further evaluate safety and effectiveness of the products and to answer additional scientific questions about the long-term safety and potential risks of breast implants that their premarket clinical trials were not designed to answer.
“Post-approval requirements are critical to ensuring the safety and effectiveness of the medical products we regulate and we’ll continue to hold manufacturers accountable when they fail to fulfill these obligations,” said FDA Commissioner Scott Gottlieb, M.D. “We’re issuing these warning letters based on the manufacturers’ low recruitment, poor data, and low follow-up rates in their required post-approval studies. We expect these manufacturers to meet the pre-specified study requirements in order to ensure the collection of long-term data that can be used to inform long-term patient safety. Post-approval studies, along with other surveillance tools such as adverse event reports, registries, and scientific literature, allow the FDA to help ensure the safety of medical devices and protect patients.” - The New York Times on March 25, 2019 had a big article “Women at Breast Implant Hearing call for disclosure of safety risks.” The implants that some patients and advocates want removed from the market have a textured or slightly roughened surface and have been associated with anaplastic large cell lymphoma, a cancer of the immune system. Dozens of other countries have already banned one type of textured implants, made by Allergan. They also discussed an association with “breast implant illness.” You can see the article HERE.
- The New York Times on March 26, 2019 had an article on “Reports of Breast Implant Illnesses Prompt Federal Review.” “The agency also issued a statement on Friday that applied to a broad array of medical devices, acknowledging that implanted devices may make some people sick. “A growing body of evidence suggests that a small number of patients may have biological responses to certain types of materials in implantable or insertable devices,” the agency said. Those effects can include “inflammatory reactions and tissue changes causing pain and other symptoms that may interfere with their quality of life.” To read the article click HERE.
To my patients,
NONE OF THIS IS NEW NEWS.
Regarding ALCL, the lymphoma associated with textured implants, I RARELY use textured implants. The only textured implants I have used are the style 410, and those are for the rare patient who requires it for a specific reason, and I for sure have a long discussion about issues with textured implants. If you have a round implant, saline or gel, you have smooth. ALCL is not a new phenomenon and it is rare. It is one reason when looking at the pros and cons of smooth vs. textured implants to pick the smooth implant.
Other things to note re ALCL:
- ALCL has ONLY been described in textured implants.
- ALCL is rare.
- 1 : 30,000. This is the risk of ALCL for women with textured implants. (no cases reported in patients with smooth implants)
- 126. This is the number of confirmed patients with breast implant associated ALCL.
- 550,000. This is how many breast implants are placed each year. (!!)
- ALCL is not a new phenomenon. You can see my original blog on it in 2011. See all my blogs on ALCL HERE.
- 93% of ALCL patients were disease free when checked at a 3 year follow up.
- Nine. The number of deaths, and none of these patients were treated with complete excision surgery and targeted therapy.
If you do have ALCL, the most common presentation is a seroma (a collection of fluid around the implant.) If your breast suddenly appears larger to you, that is a sign to come on in.
Regarding Breast implant Illness, also called implant induced inflammation, I think this is a complex issue. The two big reasons for it would be BIOFILM and Autoimmune Syndrome Induced by Adjuvants (ASIA).
Biofilm:
- I am a HUGE believer in biofilm, and I think many people who felt sick from implants and subsequently get better with the breast implant removal had a low grade colonization of bacteria by biofilm. If you have a capsular contracture, that is likely a sign of biofilm (and inflammation).
- For this reason, when I put in new implants, I use the inframammary incision, and I do a ton of things to avoid bacteria, including using a Keller funnel. Please read my numerous blogs – I have over 30 blogs on biofilm alone- on the subject HERE. Pre surgery preps, incision site, implant placement, antibiotics before during and after, no touch technique.
- For my patients, I throw the kitchen sink at biofilm. It is rare for me to see capsular contractures. But it can happen.
ASIA. Autoimmune Syndrome Induced by Adjuvants, (here the Adjuvant is a breast implant.)
- In this scenario, your body is hyperaware, and when you get a foreign body placed (and this could be any foreign body- a silicone breast implant, a knee replacement- anything), your body has a huge reaction to it.
- This is NOT common. When you look at the literature, you will see case reports, or a series of handfuls of patients. Again, over 500,000 implants are placed each year. To look at some of the studies, you can read the original scientific articles HERE on PubMed.
- BUT, if you feel bad after you have implants and just can’t quite figure out why, taking them out is an option. If you have ASIA syndrome, this will fix it. I have had patients who come in to remove implants because they have general health issues and they just don’t know why, so taking the implants out is their last step. Some get better and some do not. Again, this is a small number of people. The majority of my patients with Rheumatoid Arthritis who remove their implants still have Rheumatoid Arthritis after. If you read the literature on ASIA, it indicates about 50% of people who have unexplained stuff get better with removing the implant.
- For my patients, please read the stuff above on biofilm. I think the vast majority of patients who feel bad with implants have issues with the implant (capsular contracture, ruptured implant, etc) or have biofilm. Since 2011, (when I found out about biofilm), I changed tons of things in my protocol to avoid these issues.