New Breast Implants Warning from FDA

Scary! I have an appointment with my PS on Tuesday and will see what he thinks of the report. I'm wondering what type of testing is done for anaplastic large cell lymphoma.  The symptoms cited are pretty generic - pains, lumps, & swelling

aww shit..guess who's getting exchanged next month!!!

I was just looking around to see if there is a forum/question already about which is better, Saline or Silicone. My exchange is scheduled for March 30, my preop appt. is 3/7. I need to decide between now and then. Any opinions? Are there other forums that will have some info on them? thanks

The FDA listed the following statistics concerning the alert.  They were compiled from reports dating from 1997-2010.  They are aware of approx. 60 cases worldwide, but only gave data for 34 because they can't be sure that the others are not duplicates due to reporting methods.  They  required both Allergan/Natrelle and Mentor to post the alert, but this lymphoma is extremely rare(60 cases in women with implants world wide in approx. 13 years).  There have been millions and millions of implants used during that time period.  The number of cases is so small that they suggest no plan of action for implant users other than to report/discuss concerns with your doctor.

median age                                   51 years

median age of implant at diagnosis   8 years 

type of implant     silicone  24

                         saline       7

               not specified        3

Reason for implant     reconstruction   11

                               augmentation     19

                               not specified        4          

Nanadee:  Thank you for posting that data! 

No worries, anyone. The chances of being struck by lightning in the next year are far higher, I'm sure.

Cancer My Story..... you might see this on a few discussion boards about ACLC because of my situation and the unknowns around all of it, I see these post are back from 2011 but maybe someone else will chime in and explain anything they know,,,,, knowledge is power, right?

Somewhat a long complicated story, that was suppose to be a simple diagnoses of early detection through Mammo & Sonogram. Mammo always came back suspicious so they started to include it with a sonogram. In July 2013 DCIS was reported. Aug 2013 Bilateral Mastectomy. Cancer still seen in pathology behind left nipple, finally gave in Dec 2014 and had it removed and some revision on reconstruction. Waited the year for things to settle before reconstruction and trying to decide about gambling the reoccurrence of the breast cancer because my Doctors opinion was the odds of cancer reoccurring that was seen behind the nipple was very low, 1% maybe. I don't gamble with money so why am I going to risk losing a bet that I had already lost with even getting DCIS.

After nipple removed I was going to take 2015 off and no surgeries. Replace nipple in 2016 but Capsular Contracture aka CC started in both breast. June 2015 continue to get worse in the left breast by Sept 2015 I had to have emergency surgery and have the implant removed because it was so badly infected. Infection was draining from the incision site and breast was red. The treatment plan was to let it clear up for 6 months and then put in the horrible and dreaded expanders, approx. 3 months after that then remove the right implant and clean up CC and put in 2 new implants. Start from scratch.

Here it is 3 months later Dec 2015 I had to request an MRI of both breast because of lumps I felt and doctor reluctantly agreed, those results came back that I need further testing on left breast area where I have NOTHING to see if cancer has returned. While waiting on that test the right breast is now infected. Saw it coming on with the redness went to Dr and he put me on the antibiotics but not seeing any improvement. Actually, causing other female discomfort that normally goes along with using antibiotics that I felt after taking the 1^st pill.

Tomorrow I go for Ultrasound with Biopsy on both sides now that it is infected otherwise it would have only been the left side. Doing some of my own research because I KNOW Doctors do not have all of the answers but if anything I can help provide them with information I find in the research I do than I have to help my own cause. There are so many unknowns and then I find this link http://center4research.org/medical-care-for-adults/breast-implants-and-other-cosmetic-procedures/breast-implants-and-cancer-of-the-immune-system/

Starting with a Google search of "Does Capsular Contracture cause" and was going to ask infection but saw the word cancer so I clicked on it. The following is from that link which includes the following along with other info….

Most women were diagnosed with implant-associated ALCL by testing the fluid that collects around the implant, called a seroma.⁴ Seroma is a potential complication of breast implants and is usually not caused by ALCL. It is important to note that even when ALCL is in the breast, it is not breast cancer, but rather a cancer of the immune system. Most breast implant-associated ALCL are called "effusions", because the cancer cells are within the fluid which has collected inside the scar capsule. Women with ALCL in the scar tissue surrounding the breast can be treated by removing the implant and the surrounding scar tissue. This surgery is known as a capsulectomy.

Although there have been few studies of ALCL among women with breast implants, one clinical follow-up of nine women who had a capsulectomy after being diagnosed with breast implant-associated ALCL found that all nine were healthy and disease free when they were studied 3.5 years later, and no chemotherapy or radiation treatment was necessary.⁵ However, there have been case studies reported of women with breast implants who went to their doctors because their breasts were swollen, and the doctors found a tumor near the breast implants. These women with tumors had a more aggressive form of ALCL that recurred after a capsulectomy and needed to be treated with chemotherapy or radiation.⁵ Although earlier studies reported shorter-term results, a recent long-term follow-up of 60 patients with breast implant-associated ALCL showed that the ALCL was more likely to be fatal for women who had a solid ALCL tumor than for women who had ALCL effusions (cancer cells in the surrounding fluid).⁶ All of the patients with effusion-type ALCL were still alive 5 years after their diagnosis, compared to only 75% of the patients with solid ALCL tumors. The effusion-type ALCL tumors were also less likely to recur after treatment, returning in only 14% of patients, compared to 50% recurrence ofsolid ALCL tumors.⁶Longer studies with more patients are needed to determine the best treatments for both types of breast implant-associated ALCL.

So far, there are not enough data to show if there is more risk for ALCL among women with silicone gel implants compared to saline implants or for women who get implants for reconstruction rather than augmentation purposes.²Since it is impossible at this time to tell which women are most at risk for ALCL, it is crucial for women with all types of implants to have routine follow-ups. For women with silicone implants, FDA recommends getting a breast coil MRI three years after getting silicone gel implants, and every two years after that.⁷ Women with saline implants should have regular clinical breast exams by an OB/GYN or other physician.

Implant companies and plastic surgeons have been quick to dismiss the FDA's findings, as they have with most claims about the safety of implants. A statement on ALCL from Allergan, a manufacturer of both silicone and saline breast implants, said, "A woman is more likely to be struck by lightning than to get this condition."⁸ Four hundred people are injured or killed by lightning every year.⁹ ALCL may strike fewer women but it is an avoidable risk that most of us would choose to steer clear of, just as we do not go swimming during a thunderstorm. In addition, it is possible that there may be more cases of ALCL than have been reported. It is not standard practice to examine the scar capsule after a woman has had her breast implants removed, and it is possible that among the many women who get their implants removed every year, some have slow-growing ALCL in the scar capsule that they were not aware of.⁵The FDA is in the process of establishing a registry to monitor the number of breast implant-associated ALCL cases and plans to continue studying the link between breast implants and ALCL. While the risk of ALCL appears to be very small, many women would not want to take the chance of developing cancer as a result of breast implants. In addition, the link between breast implants and autoimmune diseases has been hotly debated for two decades, and the evidence regarding ALCL once again raises questions about the possible impact of breast implants on autoimmune disease or symptoms such as joint pain, body pain, memory loss, and chronic fatigue.

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No surprise that those making the money on the products are quick to dismiss and claim more likely to get hit by lightning….. really???? Like they said you avoid areas that increase any chance of getting struck by lightning. With additional testing maybe they would see more of a connection between ALCL and implants for any reason reconstruction or augmentation. Does this mean I don't want to have reconstruction? No not in the least. I don't want to look like this forever and yes I want to move forward but it might be with a different kind of material. Research and studies are needed and the outcome of my additional test which are still ahead.

Not sure if my situation helps any one else in any way. I really am in shock that "simple" DCIS has continued on to this journey. I know I have dark days but I hide them the best I can behind the smile that I let others see. I don't want to be that person no one wants to be around when you are always depressed. I steer clear of those type of people so I don't want to be one. Yes it is a depressing but the saying is… you have a choice on your attitude…. Maybe not your situation but your attitude you can control. And I know that all of the things going on are in God's hands. So I have to trust He will take care of it.

Does that mean I still don't cry? Absolutely NOT, I cry ALOT.

Do I have days where I am losing my spirit, you Bet I do.

But I still TRY and control what I can which is my attitude. Not easy, never going to say otherwise. But I have the most amazing friends and family so many people that I LOVE and that I really appreciate.

To be continued……