FDA Osteoarthritis Research

Synvisc-One Injections Recalled

Biotech giant Sanofi Genzyme has initiated a voluntary product recall for one lot of Synvisc-One, a brand of hyaluronic acid. The lot, which was found to contain contamination, has been linked to an unexpected increase in side effects. In an urgent “product hold” letter, doctors, clinics and pharmacies who received syringes from that lot were instructed to immediately stop using the injections on patients until the company can investigate.

“The voluntary product recall of one (1) lot of Synvisc One, lot 7RSL021, is due to an ongoing investigation which revealed the presence of microbial contamination,” said Sanofi spokesperson Heather Guzzi in an email. “Use of this voluntary recalled lot may result in a risk of infection.”

Guzzi said the recall was “initiated as a result of an unexpected increase in the number of labelled adverse events received from the U.S. market” and that “no other Synvisc-One or Synvisc lots are impacted by this recall.”

Hyaluronic acid injections, including Synvisc-One, are approved by the Food and Drug Administration to help with pain from knee osteoarthritis (although they are sometimes used in other joints) in patients who haven’t been helped by more conservative treatments, such as nonsteroidal anti-inflammatory drugs (NSAIDs). Hyaluronic acid is naturally present in healthy joints, where it acts as a shock absorber and lubricant, allowing joints to move smoothly over each other. However, the acid appears to break down in people with osteoarthritis. Injecting it into a joint – also called viscosupplementation – may lessen pain and inflammation.

Guzzi said each lot of Synvisc-One contains approximately 18,000 syringes, and about 12,380 from this lot were distributed across the United States. Although the product was linked to “an unexpected increase in the number of labelled adverse events,” she did not say which particular side effects prompted the recall. Common side effects listed on the package insert include pain, swelling, heat, redness, and fluid build-up in and around the knee.

Guzzi noted that the recall is at the physician and wholesale/pharmacy level, not at the consumer level, and that it’s “being initiated with the knowledge of the U.S. Food and Drug Administration.”

Author: Andrea Kane for the Arthritis Foundation

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24 thoughts on “Synvisc-One Injections Recalled

    1. I could not put any weight on my knee for two weeks. It has been over a month and I still can’t walk more than a short distance. Would like to know what can be done about the pain

    2. Me too. I was on a walker for 10 days, knees swelled so they couldn’t bend. Want to know what contaminated with, they won’t say!

  1. I got the shot December 11th and my knee swelled up horribly pain was tremendous cannot bear any weight on it I have been getting these shots since 2012 will the doctor tell me the truth and let me know if the shot I received was one of them that is infected

  2. I too had this lot. I was out of work for 2 weeks. I couldn’t walk at all. Had to see my pcp for a course of prednisone and pain killers. Literally had to us a chair at home as a walker tonget in and out of bed. Any word on recourses? That was terrible pain

  3. My knee swelled to over twice its size, was very tight and painful, making it difficult to walk, ice and ibuprofen / tylenol did nothing.

    1. I had Synvisc injection at the Durham, NC VA hospital, January 8th 2018, with very bad pain. This injection is the only one of many that has ever caused pain. It continues to be swollen, but the pain has diminished. How to I find out if I was infected?

    2. Immediate pain swelling and inability to walk . Limping noticibly now , Swelling gone mostly but stiffness of whole leg remains . Saw infectious disease specialist who said I would need direct culture before getting even steroid infection .worried about risk of knee replacement now or long term systemic effect now that I know I had methylobacterium thiocyanatum injected into my knee

  4. I had this injection but with lot number ending in 18. I had terrible pain and my knees swelled so bad. I had to go to the ER. At the time, I could not walk. They had to send a wheelchair to get me into the ER. They drained 90 cc of fluid on the right knee and 60 cc on the left. I am still dealing with pain.

  5. Had the injection Jan 19,2017. Have had. It. Before with good results, however, this time, I am. Fighting to try and walk without. Tripping. It’s very difficult for me to take steps. My. Pace. Is the slowest it has ever been. And. The pain and swelling. Is at its worst!, for the first time in a long time I feel like a real cripple

    I do not know what to do, I try every pain. Pill that my doctor. Suggests, but nothing is cutting the stiffness and hurt.

  6. I had this injection February 1, 2018. My knees are very swollen and I am in a lot of pain. Have to have assistance getting around.

  7. I had the injection Dec. 26th 2017. My question is how do i know the lot# that was used in my injection? Is that something the attorney will get?
    I’ve had severe pain since the injection amongst several other things. My pain is 10x more severe now than prior to. Now I’m told I need another knee surgery. I had surgery Sept. 1st 2017 with little to no relief so we decided on the Synvisc one injection instead of cortisone due to the fact Synvisc one lasts up to 1 yr of relief vs cortisone of 3 mo. So I saw him at 12 wks for my follow up and I told him my Pain and other things were worse. He decided to do the Synvisc one injection and I’ve had nothing but more extreme pain and things. So I saw him this wk only to be told I should now have a surgery that they drill holes in the bottom of your femur so that new bone grows and this supposedly takes a ‘ll the knee issues away. Well I’m not having any more surgeries now until I know what’s going on with this recall.

  8. I had 3 injections in each knee every couple of weeks since the beginning of November. I am in so much pain I walk way worse than before and now even getting around with a cane is difficult. I frequently have to use a wheel chair and cannot even grocery shop anymore. I am just now realizing as i read these cases that maybe I was injected with bad shots as well ? The pain has been excruciating.

  9. I had the injection in September of 2017. But I have these same problems. Went to the emergency. Couldn’t bare weight on my knee. Felt like I was going to tip over. My dates don’t match the lots. But im am experiencing these things

  10. I received the injection in Nov 2017 and could not walk. My physician remove as much of the gell as he could the next day. It was only in Feb that my knees began to look and feel normal. I had been using my hands to pill myself up steps. By Jan I was having an arthritis flare in my hands. During the Nov-jan time frame I was very fatigued and depressed and as someone else has said for the first time in my life I felt crippled and old.
    I just reported the even to Sanofi. Everyone should.

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