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Synvisc One, an injectable medication used to treat arthritis in the knees has been recalled by its maker Sanofi Genzyme. This is a very serious complication for the thousands of people who use this medication for pain relief. If you are on this medication, or you have taken it in the past, your first step is to contact your doctor immediately to learn more about how to safely stop taking it. In addition to this, you may be entitled to a cash settlement in some cases.
At DuBoff & Associates, Chtd., we are working with patients who have taken the Synvisc One injection and helping them to file claims with the maker and insurers for it. If you are suffering from any side effects or any illness, we encourage you to contact our offices immediately to learn more about your options – do not just settle your claim without legal representation through this process!
The Synvisc One recall has taken place. The company has recalled the use of all of its Synvisc One knee injection medications. The company sites serious health risks associated with taking this treatment. This is a voluntary recall from Sanofi Genzyme, the biotech company behind the product. It was for a single lot of the medication. The lot impacted was found to contain some level of contamination. Specifically, those who received this medication experienced a high level of side effects (more about these later).
As a result, the company has issued an urgent hold on the product – a letter was provided to doctors, all clinics, and pharmacies using the product that came from this lot. Specifically, lot 7RSL021 is being further investigated. This recall was due to the potential presence of microbial contamination, according to a release of information from the company.
The company reports that it issued the recall as a direct response to a high result of unexpected high levels of reports of adverse events. These seem to have happened in the United States specifically. Within its recall press release, the company notes that having this injection can result in an increased risk of infection in some patients.
If you are taking Synvisc One – consult with your doctor immediately. Verify that your product is not from the lot mentioned here – 7RSL021 and that you have not received injections from this lot previously.
For those who have arthritis, the movement of a joint like the knee tends to be very difficult and painful. Synvisc One, also known as Hylan G-F 20, is a type of injection placed into the impacted joint. It is an elastoviscous, high molecular weight product. It contains polymers Hylan A as well as Hylan B. These are derived from chicken combs.
Doctors prescribed this medication specifically to treat osteoarthritis in the knees. It was not a first line of treatment drug. Rather, it was often turned to when patients did not get the results they wanted from other types of drug therapies or nonpharmacologic treatment. Those who did not find relief from pain medications such as acetaminophen often had this recommended.
The drug combined three doses of Hylan G-F 20 and Hylan B hydrated gel. It was included in a sodium chloride solution with a pH level of 7.2. Generally, this medication was found in a 10 mL syringe that had three, 2-Ml doses in them. This was considered a complete treatment of the drug. Its makeup, then, included:
Side effects can occur with Synvisc One – and they have in many people. The most common high-risk side effect is an allergic reaction. This can cause an immediate, life-threatening event. It may include hives, difficulty breathing, swelling in the lips, face, and tongue, as well as loss of consciousness.
Some individuals struggle with the development of worse or severe pain located in or around their knee after they received an injection. Swelling in this area is also a sign of concern and needs to be treated by a doctor.
Other side effects of Synvisc One include:
If you have these or any other symptoms, please seek out medical help immediately.
The U.S. Food and Drug Administration has approved the use of hyaluronic acid injections like this in patients who have osteoarthritis in their needs. It can sometimes be used in other joints as well. This acid is naturally present in the body’s healthy joints and works to allow the joints to move properly and smoothly. The specific concern here is with a batch of Synvisc One that may be contaminated.
As noted, we highly recommend that anyone taking this medication or who has used injections into the knee previously to contact our offices. This is critically important to your wellbeing and in claiming the settlement owed to you. Our team has decades of experience and an aggressive style of legal support. We’ll make sure you get the compensation owed to you.
For a free consultation, call DuBoff & Associates, Chtd., immediately for a consultation. Our attorneys are available 24 hours a day to help you. Call 866-640-6665 or use our online contact form and our attorney will call you. We have offices in Silver Spring and Baltimore to help you.Filed Under: