Feel free to discuss any topic of general interest, so long as nothing you post here is likely to be interpreted as insulting, and/or inflammatory, nor clearly designed to provoke any individual or group. Please be considerate of others feelings, and they will be considerate of yours.
I sent this to Erica earlier. (She's currently recovering from her surgery, that was done this morning.) The article at the following link was posted to Medscape earlier this morning. In case you aren't familiar with Medscape, it's supposedly the one website that most doctors try to keep up with. In the past, you had to register an account there in order to gain access to Medscape articles. This may be of interest to some other members, so if registration is still required, and you don't have an account on Medsape, I've copied the entire article below.
Allergan Pulls Textured Breast Implants in US and Worldwide
Megan Brooks
Disclosures
July 24, 2019
0Read Comments
ADD TO EMAIL ALERTS
Allergan is recalling all BioCell textured breast implant products from the United States and around the world, owing to the risk for breast implant–associated anaplastic large-cell lymphoma (BIA-ALCL).
The news came in an announcement from the US Food and Drug Administration (FDA).
The agency notes that to date, 573 unique cases of BIA-ALCL and 33 deaths have been reported around the world, up from 457 cases and 24 deaths in February 2019.
Of the 573 unique cases of BIA-ALCL, 481 (84%) have been attributed to Allergan implants.
Of the 33 patient deaths, 12 of the 13 patients for whom the manufacturer of the implant is known are confirmed to have had an Allergan breast implant at the time of their BIA-ALCL diagnosis.
"Based on the currently available information, including the newly submitted data, our analysis demonstrates that the risk of BIA-ALCL with Allergan BioCell textured implants is approximately six times the risk of BIA-ALCL with textured implants from other manufacturers marketing in the US," the FDA said in a statement.
The recall includes the Natrelle Saline-Filled breast implants, Natrelle Silicone-Filled breast implants, Natrelle Inspira Silicone-Filled breast implants, and Natrelle 410 Highly Cohesive Anatomically Shaped Silicone-Filled breast implants.
The recall also includes tissue expanders used by patients prior to breast augmentation or reconstruction, including Natrelle 133 Plus Tissue Expander and Natrelle 133 Tissue Expander with Suture Tabs.
"The recall helps ensure that unused products are removed from suppliers and doctors' offices," the FDA said.
Already Pulled From Europe
Allergan took its textured breast implants off the market in all European countries in December 2018 after a French regulatory body ordered a recall. It pulled its BioCell textured breast implants off the market in Canada in May 2019.
However, the FDA announced in early May 2019 that it would allow sales of textured breast implants to continue. At that time, the FDA said that on the basis of available evidence, it did not believe the device met the standard for banning as set forth in the US Federal Food, Drug, and Cosmetic Act.
That announcement followed a 2-day FDA advisory committee meeting on breast implants in March 2019.
On the basis of the latest data, the agency has now concluded that pulling the textured implants from the market is "necessary at this time to protect the public health," FDA Principal Deputy Commissioner Amy Abernethy, MD, PhD, said in today's announcement.
Jeff Shuren, MD, JD, director of the FDA's Center for Devices and Radiological Health, said the agency is continuing to evaluate whether the risk of developing BIA-ALCL is limited to specific models of textured breast implants or applies to all textured breast implants.
"We continue to advise women and health care professionals that the use of breast implants is associated with a risk of developing BIA-ALCL and that the risk is greater with textured implants," said Shuren.
The FDA also issued today a safety communication outlining the known risks and what steps healthcare providers and patients should consider when monitoring for symptoms of BIA-ALCL, including breast pain and swelling. The FDA does not recommend removal of the recalled implants for women who do not have symptoms.
The FDA has been monitoring the issue since it first identified the possible association between breast implants and BIA-ALCL in 2011. "Since that time, we have worked to increase awareness and encourage reporting of all cases to the FDA so that we could continue to monitor this potential safety signal," said Abernethy.
Follow Medscape on Facebook, Twitter, Instagram, and YouTube
Tex
It is suspected that some of the hardest material known to science can be found in the skulls of GI specialists who insist that diet has nothing to do with the treatment of microscopic colitis.
I'm doing really good :-) It is one full week after surgery and I didn't have this particular brand of implant I had Mentor - smooth, but I can imagine it is only a matter of time that many of these will be pulled off the market. My capsule scar tissue when removed didn't look off and so it was not sent to pathology, and the implants were intact with no discolor. I wouldn't even suggest them for mastectomy either, due to the silicone shell that is what is next to the body and the over 40 ingredients that those shells are made of including heavy metals. I learned that our body immediately begins to create a capsule around them and as the silicone shell ages it can sweat or emit toxin into the capsules giving the body reason to send out immune troops to keep combating it. I fully believe that my immune system was so ramped up over time that my intestines got the brunt of this situation.
I can also say that my brain fog feels better, my skin tone and eye color are so much better and inflammation throughout my whole body has gone done a notch or two as I can feel it in my clothes. My joint pain is less so that tells me I don't have nearly the histamine going on like I have been for years. I'm sure I'm not out of the woods when it comes to my LC....my digestion was for the most part really decent during recovery. I can tell I still need to be careful what I eat though. I had a hair analysis done mid July and my results show I can use some more HCL in my stomach and a few minerals I've been low on for a while that the body needs to help combat Adrenal Fatigue (which that will take a while to recover from). Wasn't surprised by some of the food removal suggestions, have probably done most of them already. I have been given the go ahead by Pippa Galea (of Trace Elements) to messenger her or email her pipparoni@gmail.com if anyone is interested in a hair analysis with a 1 hour phone consultation for the results. She is very sweet :-)
I think I can expect to continue to keep healing and I'll be sure to report back as I notice anything, and how my LC responds to this removal of a foreign object change, if it does at all.
Thanks again for the information Tex
Hugs
Erica
To Succeed you have to Believe in something with such a passion that it becomes a Reality - Anita Roddick
Dx LC April 2012 had symptoms since Aug 2007
Thanks for the great update. I'm glad to see that everything is going well. I was wondering how the recovery was going.
Hugs,
Tex
It is suspected that some of the hardest material known to science can be found in the skulls of GI specialists who insist that diet has nothing to do with the treatment of microscopic colitis.
I'm doing really good :-) It is one full week after surgery and I didn't have this particular brand of implant I had Mentor - smooth, but I can imagine it is only a matter of time that many of these will be pulled off the market. My capsule scar tissue when removed didn't look off and so it was not sent to pathology, and the implants were intact with no discolor. I wouldn't even suggest them for mastectomy either, due to the silicone shell that is what is next to the body and the over 40 ingredients that those shells are made of including heavy metals. I learned that our body immediately begins to create a capsule around them and as the silicone shell ages it can sweat or emit toxin into the capsules giving the body reason to send out immune troops to keep combating it. I fully believe that my immune system was so ramped up over time that my intestines got the brunt of this situation.
I can also say that my brain fog feels better, my skin tone and eye color are so much better and inflammation throughout my whole body has gone done a notch or two as I can feel it in my clothes. My joint pain is less so that tells me I don't have nearly the histamine going on like I have been for years. I'm sure I'm not out of the woods when it comes to my LC....my digestion was for the most part really decent during recovery. I can tell I still need to be careful what I eat though. I had a hair analysis done mid July and my results show I can use some more HCL in my stomach and a few minerals I've been low on for a while that the body needs to help combat Adrenal Fatigue (which that will take a while to recover from). Wasn't surprised by some of the food removal suggestions, have probably done most of them already. I have been given the go ahead by Pippa Galea (of Trace Elements) to messenger her or email her pipparoni@gmail.com if anyone is interested in a hair analysis with a 1 hour phone consultation for the results. She is very sweet :-)
I think I can expect to continue to keep healing and I'll be sure to report back as I notice anything, and how my LC responds to this removal of a foreign object change, if it does at all.
Thanks again for the information Tex
Hugs
Erica
Hi Erica,
So glad you're doing well. I am 1 year post op and feel terrific. So glad to have the toxic bags out of me and I have a feeling as we go along, we will be learning more negative things about implants in general. Continued good recovery.
There are already lawsuits filed against Allergan because of their BIOCELL breast implants, as stated by this law firm.
Most cases of BIA-ALCL have been associated with BIOCELL implants.
