This blog covers more than just the FDA mandates; rather, it helps patients and everyone involved think about how their life will be positively impacted by breast implants while considering the realities of lifetime risks and monitoring. We speak to the importance of good surgeon-patient communication as well as why this may be a good time for women to update their implants.
There’s a lot of “hype” out there right now with regard to breast implants, and it’s hard for the public to know what’s real and what’s not. As a board-certified plastic surgeon with over 25 years of experience, I feel that breast implants aren’t going away anytime soon. This writing is meant to put things into perspective so that you can understand the latest information about breast implants and breast implant surgery. I highlight five main points in this blog including:
- The FDA mandate invoked upon implant manufacturers
- The surgeons’ responsibilities when recommending breast implants
- The Breast Implant Patient Decision Checklist
- How this information affects you, the patient
- What life is like after breast implants
First, in order to standardize the documentation of accurate information being shared with patients, the informed decision process has become regulated by the FDA. The FDA requires each of the breast implant manufacturers to provide physicians with an informational brochure that includes a patient decision checklist. This checklist will be reviewed and signed by both patient and surgeon and in turn re-submitted back to each implant company. The FDA is NOT deeming breast implants unsafe but rather increasing the transparency of the information. Breast augmentation today is very safe for most patients, even more so since the recall of Allergan Natrelle BIOCELL textured Gummy Bear breast implants on July 24, 2019. Although the FDA recognizes that implants in existence today have a proven track record, they want to hold surgeons and manufacturing companies accountable. Full disclosure with a systematic approach is at the heart of this endeavor. A black box warning is now issued with every breast implant sold in the U.S.
Secondly, surgeons are the vessel through which all of this information passes to patients. It’s critical that surgeons and their staff are up to date, educated and able to help patients navigate the risks and benefits of breast implant surgery. This requires excellent communication during and after the consultation process. Once patients have had time to process the verbal and written information, It’s the surgeon’s job to help patients keep things in perspective and explain anything that may be confusing. Whether you are considering having breast implants inserted, replaced or removed, it’s important to comprehend the latest science, data and statistics so that you can make the right choice for yourself. I have worked with Mentor, Allergan and Sientra.
All three implant companies have subtle differences among them. I can share my experiences with all three, and as your surgeon I am more than happy to answer any questions that you may have.
Thirdly, not only does each breast implant company (Mentor, Allergan, Sientra…) have its own Patient Educational Brochure, but the FDA now MANDATES that an Implant Black Box Warning accompany the sale of each implant which requires a patient decision checklist be reviewed and signed by each patient and their surgeon. This checklist highlights the possible negative side effects of breast implants, the materials used in breast implants, and how to keep an eye out for potential implant problems down the road. This checklist offers a condensed, easy to read, informative overview of warnings, risks and surveillance recommendations while emphasizing that breast implants are not considered lifetime devices. Included in this list are some of the clinical findings individuals have reported as a result of their implants, such as feeling “sick” because of breast implant illness (BII). Science has proven that some patients very rarely may develop lymphoma originating from the implant, called breast implant associated Anaplastic Large Cell Lymphoma (bia-ALCL). Bia-ALCL is most common in Allergan BIOCELL Natrelle, a highly cohesive and textured “Gummy Bear” implant which prompted the FDA to issue a recall. These materials are meant to provide a comprehensive summary of what a patient should be aware of as well as open healthy conversations and discussion. I compiled a condensed version of the patient decision checklist to give you a reassuring overview of what it entails:
- Prior to surgery, surgeon and patient must rule out certain medical conditions such as infection, untreated cancer, pregnancy/nursing.
- Surgery risks are higher if the patient: smokes, has diabetes, uses immunosuppressive medications or steroids, has experienced chemo or radiation therapy, or possesses a blood clotting or blood flow abnormality.
- More research is needed to better understand risks associated with autoimmune disease, mental illness and prior breast tissue manipulation.
- Possible side effects caused by implant surgery include: pain, numbness, shape and position changes of the breast, infection, swelling, fluid collection (seroma), bleeding, tissue loss, inability to breastfeed, anesthesia complications, nerve or muscle damage, and difficulty imaging breast tissue.
- Breast Implant Associated Anaplastic Large Cell Lymphoma (BIA-ALCL), although rare, can occur with as high as 1 in 3800 patients, can take several years to show up and is more common with textured devices.
- Breast Implant Illness (BII) has been reported in some women with implants. Their symptoms may include: nausea, fatigue, brain fog, joint pain, rash, or memory loss.
- Implants are NOT lifetime devices and each implant company includes a lifetime warranty with its purchase. There are differences in warranties amongst the companies so please discuss thoroughly with your surgeon. See comparative breast implant warranty summary for patients.
- Scar tissue can occur around an implant which may cause tightness or distortion of the implant, known as capsular contracture, and although rare it may necessitate further surgery.
- It is likely that additional surgery on the breast may be needed or wanted in a patient’s lifetime to change the size, position or type of implant or simply to remove their implants due to a variety of reasons including weight fluctuations, pregnancy or aesthetic ideals.
- There are alternatives to implants such as fat grafting or lifting the breast which should be considered.
- The FDA recommends monitoring the breast implant integrity with MRI or ultrasound 5-6 years after surgery and every 2-3 years thereafter.
- Patients receive an implant identification tracking card, a Patient Educational Brochure and a Patient Decision Checklist, and links to additional safety information which can be found on the manufacturer’s website.
“Dr. Gurley has found most of her patients continue to move forward with breast implant surgery to enhance their body after reviewing the patient decision checklist. They feel well informed and are willing to accept these risks and recommendations. “
Fourthly, what does all of this implant “buzz” mean to you, the prospective patient? It is important that the decision for breast implants be made very thoughtfully with your plastic surgeon, who can put all the information into perspective for you. Your surgeon can help you understand which implant options can help you get the look you want. Breast implants have been around for a long time. The tried-and-true smooth-round breast implant has minimal documented risks. Acknowledging the importance of breast and implant monitoring will optimize your health and safety after augmentation. Ruptures and other complications are very rare and early diagnosis is key. Your surgeon will always be on top of the latest science and clinical data so keep in touch with your surgeon’s practice. Our goal is for our patients to feel confident while having the peace of mind that they made the right choice. I believe all these things are possible when patients do their due diligence to find a reputable practice with a Board-Certified Plastic Surgeon.
My personal thoughts on how to keep the augmented breast look beautiful overtime is shared here. This is critical for getting the best outcome from your surgery and to keep you loving your breasts.
- Proper patient follow up is necessary to keep an eye on implants and to educate patients to report any changes that they see including movement, positioning, change in shape or size, pain, redness or asymmetry.
- Patients should be re-assured that it is OK to have a revision procedure if something doesn’t look or feel right and it is very likely that it CAN be fixed. If the breasts are firm, asymmetric, distorted, too large, sore, or swollen, it’s imperative to be examined by a plastic surgeon well-versed in implants and revision surgery. There are so many options for improvement both for beauty as well as comfort, safety and longevity.
- Find a surgeon who is adept at performing breast implant revision surgery as it can be more challenging than the initial implant placement. Revision surgery, in and of itself, does not guarantee a good result. A better predictor of great outcomes after revision surgery is the experience of the surgeon. Find an experienced plastic surgeon with the visual acuity and years of successful corrective breast surgery that is necessary to have an abundance of beautiful before and after website photos in order to be better assured that you are in the right hands.
Finally, years after augmentation, you may find your aesthetic eye or your body has changed, and you may no longer want your implants. It’s perfectly OK to have your implants removed so that you can have the size you want. Just because you have implants does not mean you have to keep them. A knowledgeable plastic surgeon will remove the implants while making sure your breast looks as beautiful as it can. Here are some reasons why you may want to consider breast implant removal:
- You may have older implants and risks could escalate with age of implant.
- You may not need or want the volume anymore due to body changes, esthetic preference or weight gain.
- Your breast size may have increased over the years leaving you with a larger breast than you currently want.
- The natural breast may have “fallen off” the implant giving the breast a strange unattractive appearance. This can be helped with implant removal, breast lift and so many more options!
- We now have many methods to correct most deformities that could be caused by implant removal, and often these maneuvers make the breast look even more beautiful than it was before!
Some great resources to help you better understand the ruling of the FDA can be found here:
The top implant vendor websites better explain company specific safety information:
Patient Decision Checklist:
Two articles highlighting information about the rare disease associated with breast implants bia-ALCL can be found here:
Please don’t hesitate to call our office with additional questions or concerns regarding breast implants and the FDA’s newest guidelines.
No one will know… Everyone will notice.™
Judy Gurley, M.D., F.A.C.S.
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