Serious concerns have emerged about the BioZorb device, a surgical marker used in breast cancer operations. According to reports, the manufacturer, Hologic, allegedly failed to disclose complaints and complications linked to the device to regulators and the wider public.
For women in Ireland who may have had this device implanted, the potential health consequences are worrying. This article explains what the BioZorb device is, why women were encouraged to have it, how Irish law on negligence and defective products applies, and what steps you should take if you are concerned about your own situation.
What is the BioZorb Device and Why Was it Used?
The BioZorb is a small, implantable device shaped like a coil or spiral, made of a material that was designed to be slowly absorbed by the body over time. It was placed into the breast after a lumpectomy (removal of a cancerous tumour while conserving as much healthy breast tissue as possible).
The intended benefits of the BioZorb were:
- To act as a marker for radiation therapy, helping radiation oncologists to more precisely target the area where the tumour was removed.
- To serve as a scaffold for breast tissue to heal around, with the goal of improving cosmetic outcomes after surgery.
- To reduce the risk of unnecessary radiation to healthy breast tissue, potentially lowering side effects.
Women often chose the BioZorb because it was presented as a medical innovation that could improve both cancer treatment outcomes and cosmetic appearance after breast-conserving surgery.
Who Received the Device?
The BioZorb was used almost exclusively in breast cancer patients who underwent breast-conserving surgery (lumpectomy) rather than mastectomy.
- Typically, these women had early-stage breast cancer where the tumour could be removed without taking the entire breast.
- Surgeons recommended BioZorb as a way to help guide follow-up radiation treatments and to support the natural shape of the breast.
- Many women agreed to the device because it was marketed as a safe, advanced tool to aid in recovery and treatment.
In short, this device was given to women already facing the difficulties of a cancer diagnosis and surgery — women who placed trust in their doctors and in the safety of medical products.
Reported Problems with the BioZorb
Despite the promises, many women experienced significant complications, including:
– Chronic pain at the implant site
– Infection and inflammation
– Scarring and disfigurement
– Migration of the device within the breast tissue
– Requirement for further surgery to remove the device
The reports suggest that Hologic knew of these complications but failed to make them public or adequately warn patients and their doctors.
Negligence under Irish Law
In Ireland, a manufacturer can be held legally responsible if they are negligent. Negligence arises where:
1. A duty of care exists (e.g. a manufacturer owes a duty to ensure its product is safe).
2. That duty is breached (e.g. failure to warn of known risks).
3. The breach causes injury or harm.
4. The patient suffers damage or loss as a result.
In the case of BioZorb, if the manufacturer failed to disclose known safety concerns, continued to market the device as safe, and women suffered avoidable injuries, that could amount to negligence.
The Defective Products Liability Act 1991
Irish law also provides strong protections under the Defective Products Liability Act 1991, which introduced strict liability for defective products.
This means that a woman affected by the BioZorb device does not need to prove negligence.
Instead, she must show that:
– The product was defective (did not provide the safety reasonably expected), and
– That defect caused injury.
If the device migrated, caused persistent pain, or required further surgery, this may well meet the test of a defective product.
How BioZorb May Give Rise to Legal Claims
The concerns about BioZorb raise two key legal issues:
1. Defective Product: If the device failed to perform safely, it may be deemed defective under the 1991 Act.
2. Failure to Warn (Negligence): If Hologic had knowledge of problems and failed to disclose them, this strengthens the case for negligence. Patients and their surgeons could not give informed consent if risks were hidden.
Together, these issues create a strong basis for affected women to explore legal action.
What Are Your Options If You Have a BioZorb Device?
If you have had breast surgery in Ireland and believe you may have received a BioZorb implant, here are the steps you should consider:
- Confirm if You Have the Device – Check your medical records or ask your surgeon/hospital whether BioZorb was implanted during your surgery.
- Seek Medical Advice – If you are experiencing pain, infection, or complications, consult your GP or surgeon. Do not delay in addressing health concerns.
- Keep Records – Document your symptoms, medical treatments, and any additional surgeries. Keep copies of medical reports, prescriptions, and receipts for expenses.
- Contact a Solicitor Experienced in Product Liability – Legal advice is essential to understand your rights. Strict time limits apply in defective product claims, so it is important to act promptly.
How Our Firm Can Help
We are an Irish law firm specialising in defective medical product claims.
We can:
- Review your case confidentially and advise if you may have a claim.
- Obtain and assess your medical records.
- Work with medical experts to link your injuries to the device.
- Pursue a claim for compensation for pain, suffering, medical costs, and loss of income where appropriate.
We understand that this is a deeply personal and difficult issue. Our team is committed to supporting women affected by defective medical devices and holding manufacturers accountable when they fail in their duty.
Next Steps
If you believe you have been affected by the BioZorb device, do not delay in seeking advice.
Contact Anthony Joyce & Co Solicitors today for a confidential consultation. We will listen to your story, explain your options, and help you take the next steps towards justice and recovery.
Disclaimer: This article is for information purposes only and does not constitute legal advice. Independent legal advice should be sought for your specific situation.
