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Silicone Breast Implant Recall Rejected By FDA Following Advisory Meeting

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Federal health officials have determined that a second silicone breast implant recall does not need to be issued due to the potential safety concerns that have surfaced recently. 

FDA officials said on Thursday that a lack of long-term testing data and known silicone breast implant complications were not enough for the agency to issue another recall for silicone breast implants, which were previously removed from the market in 1992 because manufacturers had failed to provide the FDA with necessary medical data showing that the implants were safe and effective.

Silicone breast implants returned to the market in 2006, after the FDA determined that studies did not find a connection between the breast implants and cancer. However, in recent years, some experts have criticized the agency for allowing silicone breast implants back onto the market and warned women not to use them.

The FDA decision came after a two-day meeting by the FDA’s General and Plastic Surgery Devices Panel earlier this week, which met to discuss post-marketing issues with silicone breast implants.

Manufacturers have previously reported that they have problems keeping women enrolled in silicone breast implant studies, which the FDA says it needs to be able to accurately assess silicone breast implant risks and side effects.

A number of serious complications have already been linked to silicone breast implants, including implant rupture, wrinkling, asymmetrical appearance, scarring, pain and infection.

Although a silicone implant recall will not be issued, the FDA is calling on manufacturers, including Johnson & Johnson and Allergan, to find ways to improve participation by women in post-marketing silicone breast implant studies so that there will be better data on the long-term effects of the implants.

Allergan and Johnson & Johnson have previously failed in their efforts to follow-up with women who signed up to participate in studies about the long-term effects of breast implants, with Allergan only keeping up with about 60% of its subjects and Johnson & Johnson’s Mentor unit logging a dismal 21% participation of women in its post marketing surveillance studies just three years into the research. The FDA said those studies, which were supposed to track about 80,000 women who received the implants, will be useless without higher levels of participation.

The FDA has issued several warnings to consumers regarding silicone breast implant side effects. In January, the FDA also warned that both silicone and saline breast implants may be linked to a form of cancer known as anaplastic large cell lymphoma (ALCL). While it can form in the breasts, it is not considered breast cancer.

Women who are considering receiving silicone gel-filled breast implants should be aware that they are not lifetime devices and that the longer they had them, the more likely they were to suffer complications, according to the FDA.

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16 comments

  1. Peggy Reply

    I would be happy to participate in a long term study. I have had one silicone gel implant following a mastectomy in 1985. I think there are problems with the way it healed with some adhesion, but have not had problems with it otherwise. I am concerned, however, to read that the longer one has them, the greater the likelihood of complications. I would like to know more.

  2. Debbie Reply

    I started out int he research group and reported on my 6 month visit that my breast implannts felt hard. The Doctor said they dont treat unless they hurt or look bad. I couldnt keep on a 6 months visit schedule due to work but am now 6 years into having these implants and have hard breast and auto immune disorder that can not be determined. All my joints hurt, I’m tired and have allergy like systems all the time. How can they allow these things sold!

  3. Terri Reply

    MAYBE ???? THEY ARE LIKE ME ??? A VERY SICK WOMAN SINCE I JOINED THE 2006 GROUP BY MENTOR. I HAVE LOST MY EYE SIGHT , I HAVE FIBROMYALGIA , C.F.S. . I HAVE JUST HAD 3 LUMPS COME UP UNDER MY LEFT ARM PIT . MY FAMILY DR. HAD NO IDEA WHAT IT WAS TREATED AS IF IT WAS STAFF . I HAVE BEEN ON ANTIBIOTIC \\\\\\\’S FOR A LONG TIME NOW MY PLASTIC DR. TOLD ME HE WOULD REMOVE THE IMPLANTS , I HAVE COMPLAINED ABOUT FOR 6 YEAR\\\\\\\’S NOW … GET THIS … IF I LOST 25 lbs ! GOT OUT OF THE MENTOR GROUP … AND THAT IS ALL HE WOULD JUST REMOVE ….. I HAVE LUMPS AND KNOTS UNDER MY BREAST IT FEELS REALLY BAD … BUT HE REFUSE\\\\\\\’S TO LET ME GET A M.R.I . WELL THERE YOU HAVE IT ???MONEY $$$$$$$$$$ MENTOR $$$$$$$$$$$$$ THEY ARE GOING TO PUT MY LIFE AT RISK . I HAVE A GRAND-DARLING TO RAISE… SHE IS 8 ! I AM ALL SHE HAS , MY HUSBAND PASSED AWAY 6 years AGO . I HATE THE DAY I DECIDED TO DO THIS , I LIVE WITH PAIN EVERY DAY … I HAVE MEMORY LOSS ( SHORT TERM) I HAVE A SORE THROAT , RASH\\\\\\\’S THAT JUST JUST COME OUT OF NO WHERE REACTIONS TO MED\\\\\\\’S AND FOOD\\\\\\\’S … PLEASE THINK BE CAREFUL AND RESEARCH IT IS YOUR BODY …

  4. Debra Reply

    OMG, I have had nothing but problems from the 1st week i had reconstructive surgery and silicone implants put in. The doctor told me they were safe and that he perfered to use them over saline, which i requested. I suffer from fluid retention, body swollen, headaches, anxiety, muscle weakness, pain and memory problems and fatigue. I just want the implants out now.

  5. MaryPat Reply

    Debra and .all other com mentors. Please search this site for article describing my sister (Nicole Weber’s ) nightmare. The more people who share their stories – the more people will be spared this nightmare.

  6. Becky Reply

    Really? Reject a breast implant? not surprising. Wonder who has been lobbying the FDA on the safety of such products lately. Guess that Global Breast Implant Class Action did not stop the manufacturers marketing more women one bit nor did it guarantee the safety. Its up to consumers to stop them. JUST SAY NO TO BREAST IMPLANTS DESIGNED BY MEN FOR MEN. gross.

  7. robin Reply

    I had silicone implants placed in 2007. In March of 2014 I started having major fatigue. Then I started having joint and muscle pain too. My perfect eyesight would go blurry or double vision at times. My hair started falling out by the fistfuls. After a year of not working, spending most of my time in bed or going to or from doctor appointments I have been told I have Reynauds syndrome, cateracts, dry eye syndrome, Marcus senilis in both eyes, chronic fatigue, chronic pain disorder, undifferentiated connective tissue disease, something with my autonomic reflexes (they can’t agree on what it is), I started out last March at 172lbs. I now weigh 132lbs. which I wouldn’t complain about if I weren’t 5’9″ and look like skeleton! Oh all of this stuff is going on with me and I forgot to mention I am just now 38. Well last month I noticed a pebble sized something on the right side of my right breast. I freaked and woke my husband up to make him feel. Yes, he felt it too. Of course it was a Friday night so I had a weekend to dwell. I looked at myself in the mirror and noticed my right side wasn’t laying as it always had. The left side is still perfect and you cannot feel the implant at all. Then I flexed my breast muscles and the right breast is obviously misshapen. I have always loved my breasts since I got them. Before them I wasn’t even an A cup. I got in to see my OB/GYN on the following week. She sent me to the breast center. They did a mammogram and then an ultrasound. They saw the pebble thing and felt it (I made sure!), but they couldn’t decide what it was. Then the radiologist looks at me and says he is going to send a report back to my other doctors stating everything looked fine to him. Sitting there naked from the waist up, I say to this strange man, “Are you looking at these? (as I point at my breasts) This is NOT fine!” He paused for a moment. I ask him if he could at least tell me if my implant was ruptured or not? That’s when I was informed for the first time the only way to tell was by MRI. He send me back to my OB/GYN. I went back to her and explained to her all of this. She abruptly says so you want an MRI? I said well yes. She said I was going to have to go to my primary care doctor. I set an apt with primary. I wait for that apt and then she says they don’t even mess around with breast. They refer to a breast specialist. Okay, now I go to the car and make the apt for the specialist. I wait for that apt. I go to it only for her to say, “I think you need an MRI.” I wanted to say Ya Think? So I then find out I can’t schedule it until I start my menses. I tried to explain I didn’t exactly have a cycle these days, but it was like I was speaking another language. I had the MRI a week ago and I finally got a nurse to call me back about it. She said it looks ok. There are the lateral tears. She ask if I knew about those? No I don’t know about those. Then she said she guessed they were within limits. There are okay limits for tears in implants? Seriously? She said she would talk to the doctor tomorrow afternoon when she gets in and will call and let me know what what she wants me to do next. Oh my Plastic Surgeon retired in 2012. What now? Still no answers!

  8. Kenny Reply

    My left saline ruptured I was told they cannot help me?

  9. Whitney Reply

    Finished reconstruction surgery in 2007 ever since then I’ve had chronic fatigue, allergies to medicine, food allergies, night sweats, insomnia, body aches and pains, IBS issues, migraine headaches, nausea, vomiting, hair loss, severe dry skin, weakness, major depression…Many more but you get the picture. Prior to my Cancer diagnosis I worked out 4-6 times a week and I di have to have chemo or radiation. The only thing that has changed is I have these death breasts now. I just want my life and health back.

  10. Sandra Reply

    I have had my implants for five years and found out today have too have a sonogram on my left breast and I have a lymphnode that is suspicious. Now that I read these stories I have had joint pain fever that can’t be explained memory loss and fatigue. Now I wonder if the health issue’s I have been having could have come from the ruptured implants.

  11. Bev Reply

    Can anyone please suggest a qualified surgeon to remove silicone implants in NJ area? I have the name Dr. Ahn, but she is on sabbatical.

  12. Jen Reply

    Bev, have you found a surgeon yet? I just stumbled upon this site today. If you haven’t there is a list of recommended surgeons here http://healingbreastimplantillness.com/explant-surgeons/ It is important that you have the implants removed properly (the surgical technique is called “en bloc”) and that the capsule (the scar tissue that forms around the implant) is removed. If you are on Facebook and haven’t looked for support yet there, you can search for the group “Breast Implant Illness and Healing by Nicole.”

  13. Deborah Reply

    I must have my silicone breast implants removed this Nov 7, 2016. They have ruptured and I have migrating sikicone in my breast tissue. I have seen 2 surgeons, 1 breast surgeon expert and the plastic surgeon who will remove them. They were placed in August, 1982. I understand having mine in so. long might set some record. Mine were placed between the breast tissue and the muscle so I am concerned about deformities after removal. I had them placed due to a deformity to begin with but had I known of these now recognized risks I would have not considered having them. Over the years I had problems. I had 3 surgeries to remove lumps and an underarm pit lymph node. I had hardness and a contracture develop as well as bilateral rupture. An MRI very recently revealed this. It stated “inner vag rupture”, however the age of mine indicate just one thicker bag with thicker silicone. Mine were part of the Dow Corning class action lawsuit of the early 90’s. I received no settlement. These are Surgitek Gel Foam Implants. I saw the surgeon that placed them during this lawsuit and he volunteered to remove them however another younger surgeon…the one thatlater had to do the surgeries to remove the lumps had told me earlier to leave them in that he’d seen no articles to be of any cobcern. So I did. I have had mediastinal lymph nodes measureable appear in my right lung lobe on a CT scan. I nowhave pneumonitis, ground glass findings, atelectasis and scarring in lower lung bases. I am having cgronic hoarsenees and chronic deep cough. I am chronically coughing up atypical sputum, and an having trouble getting a pulmonologist to take my condition seriously although the last one said he was looking at my lungs to see if silicone was present and said he had eritren an article on this subject. I have had immune system problems and chronically extremely high parathyroid hormone kevels as high as 158. I have a adrenal gland disorder diagnosed 2010, but although an attempt was made to determine which one it is not yet determined. So many other symptoms. I am concerned for my future health. I am 65 years old.

  14. Darcy Reply

    Due to breast cancer I unfortunately chose to have the breast Implants. One of them started to get very hard. I made the decision to have them removed. The implant removal tube was placed in the left breast. While removing the implant fluid, and waiting for the Dr. to entirely remove the implant. Things did not go well. I am extremely lucky to be alive. My son came home, unexpectedly from college that night and found me unconscious. 911 was called, sent me to ER. They told him, I was fortunate to be found when he came home, that there was Implant fluid that remained in me, that shouldn’t have been there after the removal of the implant surgery and it had gone throughout me. My memory loss and form of depression is way beyond where I want to be. I would give anything for someone to assist me in doing a lawsuit. For some reason there have been people at the hospital office that have not been nice to me at all. Any time that I have called asking questions and requesting medical copies, they have just been extremely rude. I just want some help. Thank you.

  15. Carin Reply

    My implants where implanted 11/30/1990, I was told they where the up to date best implants. Texture kind. It was a divorce present from my ex. I have had issues for years. People stop even listening to my illness, my implants where banned by US -FDA in 1991. Dow Corning polyurethane foam coating. With silicone gel. Now finally 2017 they both have erupted. My left first. Most doctors, said it was this and that. Gave me a pill and come back in 3 months. I kept asking for a special blood test and they kept refusing. I had to go to another state to get the tests I need to prove I was sick. A few mammogram later. Last year a tech squeeze a bit harder and that is what rupter the right Breast. Left one was growing bigger in two years, the pain was getting worst. A gain no one would listen. Finally I found a woman who told me about MRI for Breast, check out the FDA approves it. Had it done. Insurance paid their portion, test showed ruptured implants. Now to get them removed. Another process. Any help you may need I am all for it. Awareness I will help

  16. Tammy Reply

    I had Dow cornning implants in 1991 they were the textured gel filled I had them removed in September due to ruptured I’ve been fighting with doe for a long time now , they keep rejecting me I can’t find the M,D,L number if you know of it please let me know

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