Fri, 31 Mar 2017 14:54:43 +0000
Behaviors have consequences.
Getting breast implants is one of those behaviors that carry medical consequences, specifically a heightened risk of developing a rare type of non-Hodgkin’s lymphoma called anaplastic large cell lymphoma (ALCL) — a blood cancer that affects the immune system and typically appears in the skin, lymph nodes, or bodily organs.
Nine people in the U.S. have died from this rare cancer associated with breast implants.
It was in 2011 that the FDA first identified a possible association between breast implants and the development of anaplastic large cell lymphoma (ALCL), a rare type of non-Hodgkin’s lymphoma. But at that time, the FDA knew of few cases of this disease, and so the FDA decided to gather more information before sounding an alert about women with breast implants’ heightened risk for ALCL.
Meanwhile, the World Health Organization (WHO) concurrently determined that a rare T-cell lymphoma called breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) indeed can develop following breast implants.
And so, the FDA, with concurrence from WHO and with the collection of more data in collaboration with the American Society of Plastic Surgeons (ASPS) and the Plastic Surgery Foundation (PSF), now is prepared to issue a formal warning, although the exact number of cases remains difficult to determine due to significant limitations in world-wide reporting and lack of global implant sales data.
Here are the FDA’s findings and recommendations about Breast Implant-Associated (BIA) anaplastic large cell lymphoma (ALCL):
(1) Women with breast implants have an increased, albeit “very low” risk of developing ALCL compared to women who do not have breast implants:
- This is the FDA’s conclusion from reviewing a “significant body of medical literature” published since 2011. That literature includes case histories and comprehensive reviews of the natural history and long-term outcomes of the disease.
- The Australian Therapeutic Goods Administration (TGA) estimated the risk of developing BIA-ALCL to be between 1-in-1000 and 1-in-10,000 women with breast implants.
(2) BIA-ALCL occurs more frequently following implantation of breast implants with textured surfaces rather than those with smooth surfaces:
- As of February 1, 2017, the FDA has received a total of 359 medical device reports (MDRs) of BIA-ALCL, including nine deaths. There are 231 reports that included information on the implant surface. Of these, 203 were reported to be textured implants and 28 reported to be smooth implants. In addition, 312 of the 359 reports included information on implant fill types. Of these, 186 reported implants filled with silicone gel and 126 reported implants filled with saline.
- The Australian Therapeutic Goods Administration reported a detailed analysis of the 46 confirmed cases of BIA-ALCL in Australia, including 3 deaths. None of the cases occurred in women with smooth implants.
- Many plastic surgeons prefer textured breast implants because they attach to the tissue surrounding the site of implant.
- Nobody knows at present why and how textured breast implants cause ALCL. The French National Agency for Medicines and Health Products Safety (ANSM) had asked manufacturers of textured breast implants to perform biocompatibility testing (testing to determine how living tissues react to textured implants) and to report their findings within a year.
(3) Symptoms of ALCL in women with breast implants:
ALCL has been identified most frequently in patients undergoing implant revision operations for late onset, persistent seroma — a pocket of clear serous fluid (pale yellow, transparent bodily fluid) that sometimes develops in the body after surgery. Late onset symptoms of ALCL are pain, lumps, swelling, or asymmetrical breasts.
(4) Recommendations to physicians:
- Most cases of breast implant-associated ALCL are treated by removal of the implant and the capsule surrounding the implant and some cases have been treated by chemotherapy and radiation.
- Prophylactic breast implant removal in patients without symptoms or other abnormality is not recommended.
- Provide the manufacturers’ labeling as well as any other educational materials to patients before breast implant surgery and discuss with them the benefits and risks of the different types of implants.
- Consider the possibility of BIA-ALCL when you have a patient with late onset, persistent peri-implant seroma.
- When testing for BIA-ALCL, collect fresh seroma fluid and representative portions of the capsule and send for pathology tests to rule out BIA-ALCL. Diagnostic evaluation should include cytological evaluation of seroma fluid with Wright Giemsa stained smears and cell block immunohistochemistry testing for cluster of differentiation (CD) and Anaplastic Lymphoma Kinase (ALK) markers.
- If you have a patient with suspected BIA-ALCL, refer her to an appropriate specialist for evaluation.
- Develop an individualized treatment plan in coordination with the patient’s multi-disciplinary care team. Consider current clinical practice guidelines, such as those from the Plastic Surgery Foundation or the National Comprehensive Cancer Network (NCCN) when choosing your treatment approach.
- Report all confirmed cases of ALCL in women with breast implants to the FDA. In some cases, the FDA may contact you for additional information. The FDA will keep the identities of the reporter and the patient confidential.
- Submit case reports of BIA-ALCL to the PROFILE Registry to contribute to a better understanding of the causes and treatments of BIA-ALCL.
- Professional organizations including the Plastic Surgery Foundation and the National Comprehensive Cancer Network (NCCN) published information to help physicians understand the disease and provide diagnosis and treatment.
(5) Recommendations to women:
- Educate yourself about breast implants before agreeing to surgery. Breast implants approved in the U.S. can be filled with either saline or with silicone gel. They come in different sizes and shapes and have either smooth or textured surfaces (shells). Additional information is available on FDA’s Breast Implants website.
- Talk to your health care provider about the benefits and risks of textured-surface vs. smooth-surfaced implants.
- If you have breast implants, you should follow standard medical recommendations including:
- Follow your doctor’s instructions on how to monitor your breast implants. If you notice any changes, contact your health care provider promptly to schedule an appointment. Get routine mammography screening and ask for a technologist specifically trained in performing mammograms on patients with breast implants.
- If you have silicone gel-filled breast implants, get periodic magnetic resonance imaging (MRI) to detect ruptures as recommended by your health care provider. The FDA-approved product labeling for silicone gel-filled breast implants states that the first MRI should occur three years after implant surgery and every two years thereafter.
Breast augmentation continues to be the most common cosmetic surgical procedure performed in the U.S. Aside from increased risk of ALCL, the FDA also lists 26 potential complications that can result from implants, ranging from breast pain to necrosis (dead issue). The number of implant removals had increased last year (2016) from the year before. (Source: AOL.news)
This is a GIF I had made of what breast implant surgery looks like. Why any woman would have this entirely medically-unnecessary surgery escapes me.
H/t FOTM‘s MomOfIV
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