POTENTIAL RISKS OF BIOZORB® IMPLANTS: WHAT TO KNOW
- Oncologists use BioZorb® implants to assist in the treatment of breast cancer
- Certain patients have reported that the “bioabsorbable” implants do not absorb into the body as claimed by the manufacturer
- BioZorb® implants can cause extreme pain and serious injuries
- BioZorb® side effects can include: migration of the device, hard painful lumps, deformity of the skin, scarring (including “spider veins”), sensitivity, or itching of the skin. As a result, additional surgery and radiation may be needed.
- This firm has recently filed a number of lawsuits against the manufacturer of BioZorb®
BACKGROUND ON BIOZORB
In 2012, the FDA-approved BioZorb® as a tumor bed marker to assist in targeted radiation treatment after a lumpectomy, as well as after DCIS (“ductal carcinoma in situ”). Created by manufacturer Hologic, BioZorb® is a 3D-shaped implantable marker specifically designed to “improve outcomes in breast conserving surgery” following treatment for breast cancer or DCIS, particularly following lumpectomies. The device features six permanent, titanium clips. These clips are intended to remain in the body to help show where to target future radiation treatment.
The name “BioZorb” stems from its most-marketed feature — being “bioabsorbable.” This means that it is supposed to dissolve into the patient’s body within 12 months after implantation.
Hologic – the manufacturer of BioZorb® – claims that the device offers cosmetic value to breast cancer patients as well, creating a scaffold upon which to re-approximate remaining breast tissue. Hologic also claims that BioZorb® improves target localization and reduces the volume needing treatment for postoperative radiation therapy. However, certain breast cancer patients who received a BioZorb® device are now starting to experience injuries as a result of the implantaion.
Patients with BioZorb® report extreme pain and discomfort after receiving the implant. BioZorb does not actually absorb into every patient’s body. In fact, it often doesn’t dissolve at all, and can actually protrude from the breast itself, creating an actual, physical hole in the breast tissue. In addition, many report it making the affected breast significantly larger than the non-affected breast. Further, many patients are so distressed that they seek to either have the device removed or opt for a mastectomy to remove the entire breast.
DID YOU RECEIVE A BIOZORB® IMPLANT? IF SO, YOU SHOULD KNOW THAT THE LAW IS ON YOUR SIDE
Were you treated for breast cancer or DCIS? Did your doctor implant BioZorb®? Are you now dealing with extreme discomfort and pain? Legal resources are here to help secure justice for you, as well as potential significant financial compensation for your suffering.
WHY WOMEN ACROSS THE COUNTRY ARE NOW SUING THE MANUFACTURER OF BIOZORB
Cowper Law has filed a number of lawsuits against the manufacturer alleging that Hologic failed to properly warn victims of BioZorb®’s risks.
DO YOU QUALIFY FOR A BIOZORB LAWSUIT?
In order to file a claim against Hologic related to BioZorb®, you must be someone who:
- has been diagnosed and treated for breast cancer or DCIS
- has received a BioZorb® implant after consultation with a doctor
- is experiencing pain, discomfort, and/or any additional serious side effects including but not limited to additional radiation or an additional surgery to remove the implant
Those who meet these qualifications may be entitled to legal representation and potential financial reimbursement and should call Cowper Law at 877.LAW.3707.
PATIENTS WHO WERE IMPLANTED WITH BIOZORB® DID NOT RECEIVE ADQUATE AND PROPER WARNING AND NEITHER DID THEIR SURGEONS
BioZorb® instructions for use (“IFU”) fails to properly warn doctors and patients about the following:
- the potential failure of the “bioabsorbable” device to fully or effectively absorb into the body
- the formation of tumor-like palpable masses in the breast as a result of non-absorption
- extreme pain from BioZorb® remaining in the breast tissue
- asymmetry in shape, size and feel between an individual’s implanted and non-implanted breast
- puncturing of the breast, protruding out from the tissue, and/or creating an actual hole in the breast
The above injuries can lead to:
- an increased need for potentially dangerous radiation therapy
- an increased risk of infection
- necrosis (death of body tissue)
- telangiectasias (“spider veins”)
- permanent unsightly scarring
Other unforeseen consequences of BioZorb® can result in:
- the medical risk and financial cost of additional surgery to remove the device
- the need for more radiation
- additional mastectomy surgery
WHAT IS DCIS AND HOW DOES BIOZORB® MAKE IT WORSE?
DCIS, or “ductal carcinoma in situ,” is the presence of abnormal cells inside a milk duct in the breast. DCIS is considered the earliest form of breast cancer. Fortunately, DCIS is noninvasive, meaning it hasn’t grown beyond the milk duct and has a low risk of becoming invasive.
DCIS is typically detected during a mammogram performed as part of breast cancer screening or to investigate a breast lump. While DCIS isn’t an emergency, it does require an evaluation and a consideration of treatment options. Treatment may include breast-conserving surgery combined with radiation or surgery to remove all of the breast tissue.
As mentioned, Biozorb® was initially advertised as the next wave in breast conserving surgery, meaning that many DCIS patients would have titanium-clip markers, such as BioZorb®, included as part of their treatment regimen.
Unfortunately for breast cancer and DCIS victims, implantation of BioZorb® (sometimes done without patients’ understanding or consent) can create significant pain, itching, suffering, and result in the need for an eventual removal of the device.
If you or a loved one has suffered from DCIS or breast cancer, and your or this person’s doctor implanted BioZorb® or other titanium-clip marker without approval, you may be eligible for significant legal and financial compensation for your pain and suffering. Call Cowper Law for a free case evaluation at 877.LAW.3707.
WHAT TO DO IF YOU OR A LOVED ONE HAS SUFFERED BECAUSE OF BIOZORB®
If you or a loved one had a BioZorb® device implanted following treatment for breast cancer or DCIS, you may have a claim against the device’s manufacturer, Hologic.
Compensation may be possible in a BioZorb®/Hologic lawsuit for damages such as:
- Medical expenses
- Lost wages
- Loss of earning capacity
- Out-of-pocket costs
- Pain and suffering
Time is of the essence – please do not wait. It is crucial to consult an attorney as soon as possible if you believe you have a claim. An experienced lawyer can review the details of your case and advise you of your options for pursuing justice and compensation.
KEY SOURCES FOR FURTHER INFORMATION ON BIOZORB
This page’s content was based on the following valuable sources and reporting in regards to Biozorb®, its failings to patients, and its manufacturer Hologic:
- “Hypersensitivity Reaction Post Laparoscopic Cholecystectomy Due to Retained Titanium Clips,” Jun 21 2022. [Cureus]
- “Topic: Pain after Biozorb marker implantation and radiation treatment,” Feb 18 2022. [org]
- “Imaging Findings of 3-Dimensional Bioabsorbable Breast Implant Device,” 2021. [ Texas MD Anderson Cancer Center]
- Nelson v. Hologic, Inc., Dec 6 2021. [Casetext]
- “Surgical excision of BioZorb device eroding through the nipple-areolar complex one year postoperatively: A case report,” Mar 27 2021. [Nat’l Library of Medicine]
- “Dosimetric Effect of Biozorb Markers for Accelerated Partial Breast Irradiation in Proton Therapy,” Mar 8 2021. [Nat’l Library of Medicine]
- “Use of a Bioabsorbable Implant-Acellular Dermal Matrix Construct to Facilitate Oncoplastic Breast-conserving Surgery,” Jan 2021. [Plastic & Reconstructive Surgery]
- “Adverse reaction regarding titanium-based marker clip: case report of a potential complication,” Jul 9 2019. [Dovepress]
- “NO Informed Consent — Harmed by 5 Titanium Clips in Breast — DCIS Patient Shares Her Story and Advocacy,” Jun 10 2019. [DCIS 411]
- “MAUDE Adverse Event Report: HOLOGIC BIOZORB MARKER,” Jan 28 2019. [S. FDA]
- “A better way to treat early breast cancer,” Mar 28 2019. [Cape Cod Healthcare]
- “The Pitfalls of BioZorb® Device for Breast Cancer Patients,” May 3 2016. [Sugar Land Radiation Oncology]
- “Adverse Reactions to Titanium Surgical Staples in a Patient After Cholecystectomy,” 2014. [CRSLS]
- “A case of allergic reaction to surgical metal clips inserted for postoperative boost irradiation in a patient undergoing Breast-conserving therapy,” Oct 2001. [ResearchGate]