Topic: Becker Implants.... RECALL...?

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Sep 1, 2007 07:06 AM, edited Mar 19, 2008 01:15 PM by TenderIsOurMight

Harley and Sherry,

Here's a recent post from the 2007 FDA site, recalls and consumer safety. Is it possible what you heard, Harley is referencing this adverse report? The post appears to highlight the Becker Expander. Reading the woman's description, I get the impression she is speaking of implants placed in 1999, yet just now it's posted on the FDA adverse report list. So, we should not rush to judgement (not that you are, as knowledge is power) as I believe this preceded the next 8 years of FDA involvement in approving 3rd generation gummy bear silicone implants.

BTW, I had Mentor 3rd generation implants placed one year ago and was as confident as I could be (LOL) with the newer type cohesive gel implant. My plastic surgeon, at a large research university hospital, discussed the newer type implant and FDA approval. I am in a clinical trial (although have had to bring up the followup protocol) and am doing well. I plan on staying on top of this and will let this site know if there is any adverse event with 3rd generation silicone implants.

Best to talk with your doctor(s) and thanks for posting this question. It's always good to know what's up with expanders/implants.

Direct Link:www.accessdata.fda.gov/scripts...

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Adverse Event Report

MENTOR MENTOR/BECKER IMPLANTS SILTEX BECKER 50 EXPANDER PROSTHESIS back to search results
Catalog Number 354 - 1515
Patient Outcome Hospitalization; Required Intervention Disability
Event Description
I had my implants removed because the silicone was building up in my lymph nodes. I was in pain and becoming disfigured. I was worried about my health. I was getting more lumps than before my initial surgery. The mentor, becker implants were put in, in 1999, i am gathering records, i had a bilateral mastectomy in 1992. I had expanders then saline implants. Approx 2. 4 yrs later, 1 ruptured and both were taken out and replaced. When i woke up - it felt like there was a knife in me. The pain never went away. I had contracture. Those were taken out in 99 and replaced w/becker mentor implants. I was assured of the safety and that fda had cleared them for use. The silicone leaked into my lymph nodes.


Search Alerts/Recalls (Contained in Enforcement Reports)
(After selecting, enter device information to search Alerts/Recalls)

new search | submit an adverse event report

Brand Name MENTOR/BECKER IMPLANTS
Type of Device SILTEX BECKER 50 EXPANDER PROSTHESIS
Baseline Device 510(K) Number
Baseline Device PMA Number
Manufacturer (Section D)
MENTOR
201 mentor dr
santa barbara CA 93111
Device Event Key 809367
MDR Report Key 821958
Event Key 785166
Report Number MW1042018
Device Sequence Number 1
Product Code FTR
Report Source Voluntary
Report Date 01/07/2007
2 DeviceS WERE Involved in the Event: 1 2
1 Patient Was Involved in the Event
Date FDA Received 02/22/2007
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator Invalid Data
Device Catalogue Number 354 - 1515
Device LOT Number 195839
Was Device Available For Evaluation? No Answer Provided
Is the Device an Implant? Yes
Is this an Explanted Device?

Database last updated on July 27, 2007

Hope this doesn't create panic, yet helps to provide some details.

Tender

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Sep 1, 2007 10:36 AM Harley44 wrote:

Tender,

Now I am REALLY CONFUSED!! What kind are they talking about? The permanent expander/implant all-in-one? It sounds as if the silicone bag is breaking down and the silicone got into her lymph nodes?! WTH!?!

Sigh...

I guess it's back to the drawing board... More research!!

Thanks!
HARLEY

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Sep 1, 2007 01:15 PM melanie48 wrote:

my first idiot PS put in becker implants and he screwed me up big time.....I had to find a new Ps which redid my reconstruction with gummi bears////Dr Becker is a Dr here in my town All becker implants have been pulled off the shelf.......stay away from becker implants they are all on recall

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Sep 1, 2007 03:35 PM, edited Mar 19, 2008 01:15 PM by TenderIsOurMight

Hello All,

Somewhat surprised by Harley's post this morning, I looked at the most recent FDA recall site, under implants and up came the info about 1999 MENTOR/BECKER IMPLANTS SILTEX BECKER 50 EXPANDER PROSTHESIS. The letter is a tad confusing to my chemo brain, but the upshot appears that in January 2007 an individual reported leakage from her Becker (now Mentor owned?) expander implant which had been placed in 1999. That is relatively long ago on the silicone chart, in the sense the companies since then created a non-frankly liquid, cohesive silicone gel or matrix, which got final FDA approval in November, 2006. You can read about it at FDA.gov and various implant sites.

Harley, I doubt this 1999 expander/implant is used anymore. Knowing you, you'll be checking with your surgeon pronto to find out what maker, category and device lot he or she is planning to use and insist they run their own information search prior to surgery. It is more probable that the new expander/implant with one time surgery uses third generation cohesive gel silicone or even saline, but you do need to check this out. In the meantime, Mentor (which apparently purchased Becker) has a website and they could be contacted directly. Perhaps you wish to reconsider the all in one expander, especially if it doesn't use the cohesive gel silicone implant (Memorygel), which is similar to the gummy bear silicone implant.

I had Mentor Memorygel implants placed last year, researched the situation, asked and did not hear about problems with these newer generation, FDA re-introduced silicone gels. Alas, I am probably a bit of a lab mouse at this point as I am involved in Mentor's clinical study on this and it's probably just too early to tell, as reports take time to get filed. I did expect a followup letter for an appointment recently by Mentor or my doctor, and regrettably one did not come. So I called and am trying to work through the situation. Perhaps I will bring this to the FDA's attention when I find my identification cards for the implants. Anything to help, yes?

Betsy43, no I haven't heard anything negative about Inamed silicone gel implants. Inamed is Mentor's rival company and also are using third generation silicone gummy bear type implants. So your surgeon answered you correctly.

Melanie48, would you be able to tell us a little bit more about your understanding of Becker implant problems now? Any idea if it's the older Becker expander implants that have been retired, or as you say, recalled and forcefully retired. Does this apply to non-cohesive gel expander/implants, i.e, prior to the most recent FDA approval of 3rd generation cohesive gel? Thank you for your additional help.

Less we all shake our heads, new cohesive gel, gummy bear silicone implants are, imho, light years ahead of liquid silicone. When my surgeon demonstrated cutting one, the silicone stayed put, like it had memory. It did not move at all. I watched it for quite some time. It's hard to imagine it escaping into the contiguous tissue, and migrating into my lymph nodes. It would have to liquify to be able to do this.

We all know that other complications do arise with implants: infection, bleeding, and regrettably contracture. This must be reviewed privately with your surgeon prior to surgery through informed consent as these are realities for a small percentage of women and you should fully understand the issues. I read the whole informed consent, Mentor derived in detail, which took quite some time. But for me, it has been a remarkable, beautiful result!

Lets not get overly alarmed, but rather try to determine a little more of the facts pertaining to this 1999 implant event. I'll keep an eye on this too, as I'm as involved as you all are.

Hope this helps each of you.
Tender

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Sep 1, 2007 04:14 PM Harley44 wrote:

Hi Tender,

PHEW!!! I am getting a SALINE implant, so I guess those were ok??

I will still check with my doc, though. I don't need a snag like that ruining things!


Thanks
HARLEY

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Sep 1, 2007 07:46 PM iodine wrote:

I do not get mammograms on my recon implant side. I have no breast tissue there, I hope. I have a small augment on my good side after I had a lift, and I do get mammo on that side.,
I had a silicone on my first recon and would have loved to have stayed with it, but it was put in wrong and I had to change to part silicone/saline to get better projection.

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Sep 2, 2007 09:02 AM Harley44 wrote:

Thanks, I'll check it out!

HARLEY

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Sep 2, 2007 11:40 AM betsy43 wrote:

Tender,

Thanks for answering my post. So far, I've been very pleased with my Inamed implant. Hope this with the Becker's is not as serious as they think. Keep us posted.

Betsy43

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Sep 2, 2007 02:46 PM Harley44 wrote:

Thanks, Jean,

I will be getting in touch with my ps to see what he thinks.

There is nothing I can do right now, with it being the Holiday weekend, so no use brooding about it. I'm sure that I'll get the right implants.


Hugs,
HARLEY

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Sep 3, 2007 07:52 AM Harley44 wrote:

Ruby

Thanks! I'll ask some more questions! I really don't want to even have this ONE more surgery... I guess I'd stay flat, if not for the idea of having to look at my chest, all scarred up...

Glad you are happy with your results!

HARLEY