Certain EXOGEN® Ultrasound Gel Pump bottles have been marked for recall by Bioventus, the product’s manufacturer. According to a recall notice issued last month, an undisclosed microbial substance has been detected in certain batch numbers of the EXOGEN Gel product. The use of a contaminated bottle of this product can cause a severe bone infection in some patients.
Contaminated lot numbers are:
- Lot 190: 190204, 190211, 190213, 190215, 190226, 190228, 190230, 190235, 190235T, 190250, 190251, 190252, and 190263
- Lot 200: 200201, 200203, 200207, 200212, 200212T, 200215, 200215T, 200218, 200227, 200228, 200228T, 200229, 200240, and 200240T
You can find the lot number towards the bottom of the bottle in fine print. It should be displayed as XXXX-XX, so 1902-04, for example.
What Should You Do If You Have a Recalled Bottle?
Do you have a bottle of EXOGEN Gel that is slated for recall? Stop using the ultrasound gel immediately and call your primary care physician for further instructions. They can tell you about an alternative gel that is safe for use with the EXOGEN Ultrasound Bone Healing System. Or your doctor might be able to immediately refresh your prescription for the gel, so you can get a new bottle from a non-contaminated batch.
Once you speak with your doctor, secure the contaminated bottle in a secure location. Make certain it is not in direct sunlight and not located where a child or pet could find it. Placing it in an airtight plastic bag is advised. Do not discard or send back the contaminated bottle to Bioventus, even though the company will likely tell you to do just that.
The contaminated bottle of EXOGEN Gel could be the most important piece of evidence in your claim. Without it, Bioventus and their attorneys might try to argue that your bone infection was caused by something else entirely and that you never used the contaminated gel. Keeping that bottle keeps this evidence in your hands. You should only send it away to Bioventus for further analysis after your attorney has documented the bottle and approved for you to relinquish it, which might not happen depending on the contentious or cooperative nature of your claim.
What Can the Contamination Do?
Bioventus’s press release notes that it has not received any information about “adverse events” caused by contaminated batches of EXOGEN Gel. This information is no longer accurate, though. Contaminated EXOGEN Gel has been linked to at least one case of severe bone infection in a user.
EXOGEN Gel is applied to the skin nearest a fractured bone before an in-home ultrasound machine is used to stimulate bone cell regeneration in the area. The application is done at least once a day, which means contaminated gel would have many opportunities to trigger an infection. The microbial substance in the gel can seep through the skin, penetrate the vulnerable and fractured bone, and cause a bone infection that requires specialized medical treatment.
Bone infections can cause:
- Worsened pain around the broken bone
- Sweating, chills, and high fevers
- Full-body exhaustion
- Swelling and redness in the affected area
- Leaking wounds at the infection site
- Necrosis of the bone tissue
If bone tissue dies due to the infection, then the patient’s symptoms will worsen. Severe necrosis might require the infected bone to be removed or limb amputation. It can also cause death if untreated due to high blood toxicity levels in the patient.
How Do You Sue Bioventus for EXOGEN Gel Infections?
Bioventus is a pharmaceutical and medical supply company based out of North Carolina and with multiple subsidiaries. The corporation likely has powerful defense attorneys standing at the ready to challenge any bone infection claims filed by EXOGEN Gel users. If you want to sue them, then you should bring powerful legal counsel of your own.
Jamie Casino Injury Attorneys is a highly experienced personal injury law firm in Savannah, Georgia. Despite the relative newness of the EXOGEN Gel recall, we are already representing at least one client who suffered a severe bone infection in their ankle after using contaminated EXOGEN Gel. Trust in our Dream Team of legal professionals if you are in a similar situation, too. We will fight for your right to compensation after suffering so much due to a dangerous medical product defect.
You can call our law firm at (912) 809-5335 to schedule a FREE initial consultation at your earliest convenience.