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- FAQs About BioZorb Removal & the Recall
- The Real Deal: Is BioZorb Removal Necessary?
- Does the Recall Mean I Have To Get It Removed?
- When Should I Call My Doctor?
- What if I’m About To Start Radiation?
- Is Removal Always the Better Choice?
- How Do I Report a Problem?
- Should I Talk to a Lawyer?
- Real Answers from the Defective Medical Device Attorneys at Bernheim Kelley
If you had a BioZorb marker placed after breast cancer surgery and then heard about the recall, your first thoughts were probably, “Do I need to get this thing out of me? Do I need another surgery? Is BioZorb removal necessary? How do I know if it has already done damage?”
These are all valid questions, and we know that uncertainty can be incredibly stressful. The short answer may surprise you: A recall doesn’t automatically mean removal. But that doesn’t answer all your questions, does it? Here we’ll talk about what the FDA actually recommended, what to watch for, when to call your doctor, and whether you should consult a BioZorb attorney.
FAQs About BioZorb Removal & the Recall
Not necessarily. The recall reflects a pattern of complications across many patients. Your individual risk depends on your symptoms and imaging, which your doctor can give you more information on.
The plastic portion was designed to absorb over about a year, but the recall stems from cases where it didn’t. Whether yours is dissolving as promised or not is something to discuss with your doctor as soon as you can. However, the titanium marker clips inside it are permanent.
Follow your regular screening and follow-up schedule. But if you have a BioZorb marker, ask your doctor whether any additional imaging makes sense.
BioZorb explantation is surgery to remove the device. The FDA says BioZorb removal isn’t needed unless your healthcare provider recommends it. So, this is a decision to make with your doctor based on your symptoms, imaging, and overall health.
If your symptoms have resolved, follow your post-treatment care plan. If you have lingering issues, raise them with your medical care provider as soon as possible.
The Real Deal: Is BioZorb Removal Necessary?
The BioZorb recall doesn’t automatically mean you need removal surgery. The FDA says patients don’t need to have the device removed unless their healthcare provider recommends it.
However, you need to be vigilant. Your health is vitally important.
Call your doctor if you have any of the following:
- Pain
- Swelling
- Redness
- Drainage
- Fever
- Signs of infection
- Skin erosion
- A new lump near the surgical site
Does the Recall Mean I Have To Get It Removed?
No, not necessarily. But it does mean you need to pay close attention.
When the FDA flagged BioZorb, it did not tell every patient to have the device taken out. For patients who already have a marker and are not having problems, the guidance was to monitor and stay in touch with your care team rather than rush into another surgery. The FDA’s position was that removal is not necessary unless your own healthcare provider recommends it. If you aren’t having problems, your doctor may simply want to keep an eye on it rather than remove it.
But remember, the BioZorb recall happened for an important reason. Unused BioZorb devices were pulled from the market because of reports that they could fail to absorb, move, erode through the skin, or cause infection. The FDA currently lists 252 reported injuries and no reported deaths. So while removal isn’t the automatic next step, this isn’t something to ignore either.
The best answer is the one you reach with your medical providers, based on your symptoms and your imaging, not based on a notice and fear.
When Should I Call My Doctor?
Reach out to your care team if you notice any of the following:
- New or worsening pain near the surgical site
- Swelling, redness or warmth, drainage, or other signs of infection
- A lump or hardening that you can feel
- Any sign that the device is pushing toward the surface of the skin
If you have a fever, worsening breast pain, or other signs of infection, contact your care team immediately.
None of these symptoms guarantee that you have a serious problem. But all of them are worth seeing a medical professional to make sure you are okay. You know your body better than anyone, and a quick call beats waiting, wondering, or worsening.
What if I’m About To Start Radiation?
Bring it up with your doctor before treatment begins. The FDA noted that BioZorb was not cleared for use as a marker for radiation therapy and advised patients who are about to undergo radiation to discuss the risks with their providers first.
Your radiation oncologist needs to know the device is there so they can give you the best care possible. This is a short conversation that could have a huge impact on your health, and it is worth having as early as possible.
Is Removal Always the Better Choice?
Not necessarily, and this is where many patients are surprised. Taking the device out is itself a surgery, with its own risks and recovery. For some patients, especially those with serious complications, removal is clearly the right call. For others, continued monitoring may make more sense.
This is a decision that needs to be made with your medical team. A good surgeon will walk you through the risks and benefits in your specific situation rather than hand you a one-size-fits-all answer.
How Do I Report a Problem?
Tell your provider first, always. Beyond that, you can report a device complication directly to the FDA through its MedWatch program. This is how the agency tracks safety issues. Reporting helps build the record that there is a problem, how widespread it is, and urges regulators to take action if necessary. And it takes only a few minutes.
Should I Talk to a Lawyer?
Your health comes first. If you’re having pain, signs of infection, a new lump, skin changes, or another concern around your BioZorb implant, talk to your doctor about what’s happening and what care you need.
You should also consider talking to a lawyer if you believe your BioZorb caused serious complications, required additional treatment or surgery, or didn’t absorb as expected. A defective medical device lawyer can review your case and let you know if you may have a BioZorb lawsuit.
You don’t have to know whether you have a case before you talk to someone about it. That’s exactly what a consultation is for.
Real Answers from the Defective Medical Device Attorneys at Bernheim Kelley
If your marker left you with more pain, more medical care, more health issues, or needed to be removed after everything you’ve already been through, you deserve Real Justice.
Bernheim Kelley is currently investigating BioZorb claims and accepting new clients nationwide. Our defective medical device attorneys can listen to your story, review your case, lay out your options, and help you decide on next steps.
You trusted this device to help you, and instead it just caused more suffering. Let’s see if we can’t get accountability and the support you need to move forward. Call 617-420-1111 or contact us online today to set up a FREE case review. And remember, you don’t pay us unless we win.
This article is general information, not medical or legal advice, and it does not create a doctor-patient or attorney-client relationship. Decisions about your health should be made with your own licensed healthcare provider. Bernheim Kelley Injury Lawyers is currently reviewing BioZorb claims and taking new clients nationwide. Attorney advertising.