Textured Breast implants

cdicapua

I had a mastectomy with reconstruction 7 yrs ago. I recieved a letter from my dr informing me about textured implants and lymphoma. I am concerned because I have read about other problems related to textured implants. Has anyone heard of this and does anyone have this proble

Beesie

From the FDA: https://www.fda.gov/medical-devices/breast-implants/breast-implant-associated-anaplastic-large-cell-lymphoma-bia-alcl

From the American Society of Plastic Surgeons: https://www.plasticsurgery.org/patient-safety/bia-alcl-summary

On this discussion board: https://community.breastcancer.org/forum/44/topics/860981?page=1 and https://community.breastcancer.org/forum/44/topics/869291?page=1

What it comes down to is that there is a very small (a fraction of a percent) risk, associated mostly with textured implants. Doctors - and now patients, hence your letter - are being informed about the risk of BIA-ALCL and are being told what symptoms to look out for, but there is no recall and no action is required by patients who are having no problems with their implants.

I've been on this site for 13 years and I can only think of two possible cases that I've seen mentioned here, and I don't know that these have been confirmed as being BIA-ALCL.

niffer291

Hi,

I have the textured implants and have had them for 10 years. I have scheduled a DIEP flap surgery for this June so I can get rid of the implants and have my own tissue. I have never liked the implants, they are cold, under my muscle so they look strange, can't find a bra that fits etc. So I am diving in head first into a new surgery.

I am looking forward to it but of course nervous, but if I can get rid of the flap of my belly from being pregnant with twins I will be happy!

angelfaith456

After getting an MRI a few weeks ago because my oncologist heard my complaints of ongoing pain; one of my implants are leaking. And yes I have the textured ones. Met with new plastic surgeon who said if it was his family member, he'd recommended removing them "sooner rather than later"...SMH😡..I'm almost at my 5 year mark. He seemed perplexed that the first ps put in textured anyway. My mind was made up to get them out anyway because I really felt that something was wrong.

A very close girlfriend (and cancer survivor) works for a subsidiary of the company says they are all made by the same company. So 9 times out of 10, I have the recalled implants.

At what point does this end???

MinusTwo

I have had the 410 implants for 9 years. I like them. i don't find them cold or hard the cleavage is great and the shape is very natural. That said, if you read Beesie's post, the FDA is NOT recommending removal of implants if you're not having any problems. I've had an appointment to see my PS for a couple of months and an interested to talk with him next week. I'm curious if he'll recommend an MRI. But at the point, I have no plans to "explant".

MinusTwo

I am posting this on several threads that are discussion the recalled implants. And BTW, it is not implants in your body, only what was in stock on the shelves.

I have the Allergan 410 Anatomical Textured implants. They were "installed" in 2011. I really like the implants so I determined to have some testing before jumping off the cliff. My MO ordered both a diagnostic ULS and an MRI. I went back to the radiologist who was 'spot on' for my original diagnosis.

I had already seen both the PS and the MO and both of them said they don't see any problems, but...

Today I had the ULS. This is a radiologist that I REALLY trust. He has seen a couple of ALCL instances out of a ton of people. I wanted an ULS to verify - and maybe an MRI follow up. In his opinion, he has seen either fluid or a mass if the patient has ALCL. He saw nothing abnormal on my films. My gut reaction is NO - I am not going to explant and I am not going to have any more surgery just now. As I suspected, my pain is likely from radiation after effects. When I pushed him for a 'survivorship plan', (my MO basically says do nothing) he suggested I come back every two years since I already had a recurrence 2 years after the original cancer & implants. He said many women come every year because they are worried and need reassurance or to have their hands held. Not a judgement, just a fact.

He said I can surely have the MRI if I want, but I am confident enough of his skills that I will pass on the MRI & extra radiation for now. And I will agree with my PS that I don't need to worry so much.

Calico

MinusTwo,

Good for you that you found a doc that you can trust and who has been thorough. Just a quick note on the MRI, there is no radiation involved. Having my MRI in a couple of weeks and go from there, looking for answers on my 410's. I know for a fact that I do want mine out incl. capsule, just have to find a skilled plastic surgeon after I get my results.

Randi64

I just switched out my 410's and had a complete capsulectomy on 9/20. I'm working with a well known, well respected PS in a major cancer center in Philadelphia. My surgeon was VERY supportive of removal. He has not used these implants in years and he said the risk seems much higher than originally thought. I'm not a "wait and see" type of person and feel relieved they are out. I'm so sorry that any of us are faced with yet another decison and more surgeries. Good luck to all!

rmgrmg

Randi64, good for you for being your own advocate. I think many of us with textured implants are concerned after the FDA recalled biocell,which increases the risk for BIA ALCL 6x. The FDA has not recommended explantation/capsulectomy of textured implants likely because there are no large clinical trials indicating that removal is preventive of ACLC nor are there clinical trials indicating that removal causes complications for BIA ALCL. True, the 1st BIA ALCL conference webcast revealed some patients, perhaps harboring BIA ALCL subclinically, developed BIA ALCL years after total capsulectomy. However, we don't really know the flip side of the coin- how many cases of BIA ALCL were prevented due to prophylactic capsulectomy until there is a large clinical trial with statistical power to adequately predict how many cases of BIA ALCL were prevented or not. Ironically, someday those of us with textured implants, whether we explant or not, will make up adequately sized future clinical trials to determine with statistical significance and power the outcomes of prophylactic textured implant removal and capsulectomy.

Beesie

My understanding is that 8 years is the average time to diagnosis of BIA ALCL, with some cases developing within a year and some cases developing after 30 years. So a longer time having the implants in place is not necessarily a factor that increases risk but 8 years is the average when looking at all cases worldwide.

The most recent estimates put the number of BIA ALCL cases worldwide at under 1,000 (out of millions of implants). Based on this, it is difficult to come up with any definitive patterns about how and when BIA ALCL might happen. At this point, based on these known and confirmed cases, it appears that most cases are caught early and cured by the surgery alone.

"The risk of developing BIA ALCL is lower than the risks associated with an anaesthetic and surgery. The complication rate of revision surgery involving implant removal or replacement is also higher with each revision procedure." https://www.tga.gov.au/breast-implant-associated-cancer-or-bia-alcl

It is important to be your own advocate. This means ensuring that you have all the relevant information and making the best decision for yourself and your situation. For some people this will mean explanting; for others it will mean leaving their implants in place. Given the complexity of this issue, I hope that everyone posting on this site is open-minded and encourages everyone to decide for themselves what is right, rather than encouraging people to go in one direction or the other.

MinusTwo

Beesie - thanks.

As some of you may know, I have absolutely no plans to "explant". I love my Allergan 410s. I also read the 30 pages of fine print before I had reconstruction. I am at 9 years with no particular problems. I saw my PS a month ago and he sees no indication of fluid collection or other indications of ALCL. I also had an ultrasound, and that radiologist (who has seen only 2 in spite of being at a major medical center) saw no indication of ALCL. I badgered my MO to write an order for an MRI at the same time he ordered the ULS, but I'm not sure it I'll bother at this point in time.

Yes, everyone must research all the information and make a personal decision. Another hard choice we're sort of forced into making. I just hope people won't panic.

rmgrmg

Again I also support and commend self-advocacy, researching the facts for oneself, and self-direction. I also agree all should respect other choices, which can vary from case to case, depending on one' personal situation. Clearly, we should all keep an open mind and respect each other's personal choices and decision-making, even if they differ from our own.

rmgrmg

Beesie, thanks for the post and link, too, which supports removal of implants in certain cases as follows: "Generally, breast implants are not lifetime devices, regardless of breast implant associated cancer. Typically they are removed after 10-15 years. The longer you have the implant, the more likely it will need to be removed. Common reasons for removal are contracture (hard or painful implants) or movement of the implant."

https://www.tga.gov.au/breast-implant-associated-cancer-or-bia-alcl

Mogil411

@Randi64. I would live the name of your Phila area PS just in case I need a second opinio

Beesie

rmgrmg, what you quoted is something that I hope every woman with implants knows and knew prior to getting implants. There is nothing new about this and it has nothing to do with BIA ALCL, which is what I thought this discussion was about.

The fact is that plastic surgeons are discovering that many implants do last much longer - possibly a lifetime (depending I suppose on what age you get the implants). I've had this discussion with two Plastic Surgeons over the past year or so. That said, everyone of us should be prepared for possible complications and for replacement at some point, due to normal 'wear and tear'.

rmgrmg

The FDA and ASPS/ASPSP are not recommending removal of text. implants unless they have complications-- perhaps due to longevity or other reasons. I agree that implants often last longer than their common 10 year warranties, but not all implants are equal where some are known to have issues sooner than others, If someone has such problems and other complications with their textured implants then removal, with or without replacement, may be warranted, with prophylactic capsulectomy considered in case that may have the potential to prevent BIA ALCL. But others may not be having problems with their textured implants and following the recommendations of not explanting is warranted. I also think it is advisable that anyone with textured implants to keep abreast, no pun intended, and up-to-date with BIA-ALC news feeds on FDA and ASPS sites as the lymphoma is an ever-changing disease with changing risk profiles and recommendations subject to evolve as more data are collected and ALCL is further studied.

https://www.ncbi.nlm.nih.gov/pubmed/29879005

NisaVilla

Please share opinions. I will have my July-2019 recalled textured implants removed and am wondering what to replace them with? My left implant has been causing pain for over a year. I went to see surgeon about pain and left consult with a new surgery appt. No fun after having gone through four surgeries to get them just right but the increasing pain, although tolerable, bothers me as it sometimes wakes me up. I was contemplating going flat but as the date approaches, my mind and body seem to want new implants. Thank you for any feedback or good resources.

Kathleen21

I am having my implants removed and replaced on Monday March 16. I have read many articles and have spoken with many doctors. Both my medical oncologist and plastic surgeon are in favor of removal and replacement. I am not looking forward to another surgery but I can't worry that I will develop BIA ALCL. Recurrence is always a worry and coupled with radiation which can also produce another cancer I feel a third reason is too much to gamble with. I am in NY and go to Sloan.

MinusTwo

Kathleen - Everyone has to make their own decisions. Good luck with your surgery.

As I've said in many posts, I love my Allergan 410s. I've had them since 2011 and am not having any problems. My MO, RO, BS, PS are all on the same page - leave them alone. I did have an ultrasound and a breast MRI last fall which confirms no problems. The radiologist recommended an ultrasound every two years. So I'm standing pat.