What Women Have to know Concerning the Textured Breast Implant Recall

 

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Women with breast implants are all around us. And many of these women have no health issues at all from these implants. However, Allergan voluntarily issued a worldwide recall of Biocell textured breast implants and tissue expanders that have been linked to a rare cancer. The uptick in media stories and the global recall have naturally inspired fear in women who have received textured implants, but the chance of developing BIA–ALCL remains low. Health Canada.

On July 24, the FDA recalled Allergan BIOCELL textured breast implants because of the increased risk of anaplastic large cell lymphoma, also called BIA-ALCL. Breast Implant Recall: What You Need to Know Written By:Stacy Simon July 25, 2019 The pharmaceutical company Allergan has recalled all BioCell textured breast implants at the request of the US Food and Drug Administration (FDA) because they have been linked to a rare type of lymphoma: breast implant associated anaplastic large cell lymphoma (BIA-ALCL). July 24, 2019 Pharmaceutical giant Allergan has ordered the recall of all of its BIOCELL textured breast implants after the FDA flagged a. MIAMI (CBSMiami) — Earlier this year, breast implant manufacturer Allergan voluntarily recalled its BIOCELL textured breast implants. However, what does that mean for the women who have those implants in their bodies right now?

While some doctors are removing more and more implants, others say, there is no need to rush in to surgery. Allergan voluntarily recalled its Biocell textured breast implants last week after the Food and Drug Administration (FDA) pushed for the company to take. After announcing earlier this year they would NOT issue a recall, the FDA is doing an about-face by announcing medical device maker Allergan has agreed to.

Something to note: While the administration requested the recall the affected Allergen textured implants and urged their removal from shelves and future procedures, the FDA doesn’t advise women to. No. It’s not a mandate like a recall of a car that will malfunction for sure if you drive it.

Currently, both the FDA and the American Society of Plastic Surgeons advise against removing textured breast implants in the absence of symptoms. Keep in mind that over 99.9% of women with Allergan implants will never get ALCL.

List of related literature:

Recently published studies have shown that women with silicone gel-filled breast implants do not have a greatly increased risk of some well-defined autoimmune diseases, which were among the serious health concerns surrounding the devices.

“Consumer Health USA” by Alan M. Rees
from Consumer Health USA
by Alan M. Rees
Oryx Press, 1997

Poly implant prothese asymmetrical anatomical breast implants: a product recall study.

“Breast Cancer Management for Surgeons: A European Multidisciplinary Textbook” by Lynda Wyld, Christos Markopoulos, Marjut Leidenius, Elżbieta Senkus-Konefka
from Breast Cancer Management for Surgeons: A European Multidisciplinary Textbook
by Lynda Wyld, Christos Markopoulos, et. al.
Springer International Publishing, 2017

In the 1980s, women with silicone implants reported certain patterns of illness, including severe joint and muscle pain, fatigue, and weight loss.

“Encyclopedia of Business Ethics and Society” by Robert W. Kolb
from Encyclopedia of Business Ethics and Society
by Robert W. Kolb
SAGE Publications, 2008

McLaughlin JK, Lipworth L, Murphy DK, Walker PS (2007) The safety of silicone gel-filled breast implants: a review of the epidemiologic evidence.

“Breast Reconstruction: Art, Science, and New Clinical Techniques” by Melvin A. Shiffman
from Breast Reconstruction: Art, Science, and New Clinical Techniques
by Melvin A. Shiffman
Springer International Publishing, 2015

Cook et al., “Self-Reported Breast Implants and Connective Tissue Diseases in Female Health Professionals,” Journal of the American Medical Association 275 (1996): 616–21.

“Autism's False Prophets: Bad Science, Risky Medicine, and the Search for a Cure” by Paul A. Offit
from Autism’s False Prophets: Bad Science, Risky Medicine, and the Search for a Cure
by Paul A. Offit
Columbia University Press, 2008

Since 1992, the use of silicone gel breast implants has been restricted by the Food and Drug Administration (FDA) based on concerns related to autoimmune and connective tissue disorders.

“Plastic Surgery Secrets Plus E-Book” by Jeffrey Weinzweig
from Plastic Surgery Secrets Plus E-Book
by Jeffrey Weinzweig
Elsevier Health Sciences, 2010

Another study that demonstrated the importance of a longer follow-up period evaluated the impact of silicone-filled breast implants on the immune system in 32 patients attending a specialized autoimmunity clinic.

“Vaccines and Autoimmunity” by Yehuda Shoenfeld, Nancy Agmon-Levin, Lucija Tomljenovic
from Vaccines and Autoimmunity
by Yehuda Shoenfeld, Nancy Agmon-Levin, Lucija Tomljenovic
Wiley, 2015

Millions of women have undergone breast implant surgery since silicone gel–filled implants were introduced more than 40 years ago, and implantation surgery continues to be one of the most popular procedures in plastic surgery.

“The Breast E-Book: Comprehensive Management of Benign and Malignant Diseases” by Kirby I. Bland, Edward M. Copeland, V. Suzanne Klimberg
from The Breast E-Book: Comprehensive Management of Benign and Malignant Diseases
by Kirby I. Bland, Edward M. Copeland, V. Suzanne Klimberg
Elsevier Health Sciences, 2009

Affected women may notice decreased breast size, pain, tingling, swelling,numbness,burning,or changes in sensation.With silicone implants, silicone gel may migrate away from the implant, causing hard knots in the breast and lumps (granulomas) in the chest wall,armpit,arm,or abdomen.

“Breastfeeding Management for the Clinician: Using the Evidence” by Marsha Walker
from Breastfeeding Management for the Clinician: Using the Evidence
by Marsha Walker
Jones & Bartlett Learning, 2010

More recently, there have been a number of large studies which have failed to confirm an association between the development of autoimmune diseases and silicone breast implants [233–235].

“Systemic Lupus Erythematosus” by Robert G. Lahita
from Systemic Lupus Erythematosus
by Robert G. Lahita
Elsevier Science, 2004

Oktay Kutluk

Kutluk Oktay, MD, FACOG is one of the world's foremost experts in fertility preservation as well as ovarian stimulation and in vitro fertilization for infertility treatments. He developed and performed the world's first ovarian transplantation procedures as well as pioneered new ovarian stimulation protocols for embryo and oocyte freezing for breast and endometrial cancer patients.

Mail: [email protected]
Telephone: +1 (877) 492-3666

Biography: https://medicine.yale.edu/profile/kutluk_oktay/
Bibliography: oktay_bibliography

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6 comments

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  • My mom has the natrelle texture implants for 13 years and now she needs to replace them for new ones, because they are ruptured from inside..
    I have round smooth mentor implants, I think they are much safer than the texture ones. I’m also awared that I will need to earn money and put it on the bank for a decade or so, in case I’ll need to replace them.
    Luckily my mom has a good health insurance so next year she can get the surgery again (she is 45) but I believe when she turns 60 she will need to take them and have enough money earned to replace them or quit implants forever.
    I’m planning to quit implants when I get 50-60s I won’t need them anymore and really I don’t want to suffer any condition when I get older.

  • Dear Dr. Youn,..After watching your videos I realized that I have a pair of Allergans recalled implants:/…I called a great local surgeon, and I have filed a claim, and will be having them replaced.:).”Thank you” for your very educational videos. You literally are saving me from the risk of ALCL….
    Good thing I included #Graviola in my diet, for wellness….Let’s pray my replacement surgery goes well….
    Many thanks

  • Its to late
    the supplier will be sued for some time.

    Why is it that the other companies takes it time to recall while other companies already have issued an recall.
    Its a issue all over the world. ��

  • I respect your willingness & knowledge to address this issue
    Not a personal concern of mine, knowing in wisdom that everytime we enter into anything thats invasive…yes there are risks & thats ‘why’ people need a physician who is willing to educate & discuss honestly…..let Wisdom be our guide in “all” things
    Much respect,
    thank you Dr.Youn

  • Regyardless of what kind of implant is being used in the delicate human body’, Autoimmune problem’s are popping up more and more,!! We will be seeing the awakening of a wiser and more mindful woman when she takes her time to realize her ego and her self image was not healthy in the first place…My daughter is learning this lesson now and has a very important decision to make about what she’s done to her own body.

  • Thank you for this important information. Question, is the company responsible for the replacement of a different implant and medical expenses?