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The Biozorb medical device is implanted in women who have undergone a lumpectomy procedure. It is a bioabsorbable marker that helps to guide radiation therapy, ensuring precise treatment, and was marketed to improve cosmetic outcomes after procedures. However, issues with the device have surfaced, including complications with pain, infection, and device migration, which can lead to severe health problems.
Cowper Law filed the firm’s first case against Hologic. The firm is investigating hundreds of potential cases, after a case is vetted by attorneys, it will be pursued individually.
The U.S. Food and Drug Administration (FDA) issued a Safety Communication. BioZorb Markers and Potential Risks with Use in Breast Tissue: FDA Safety Communication | FDA
The U.S. Food and Drug Administration (FDA) classified a Class I recall with BioZorb Marker and BioZorb LP Marker devices which corrected the recommendations for patients and health care providers. The recall recommended health care providers be aware of reports of serious adverse events with use of BioZorb Marker and BioZorb LP Marker devices in breast tissue.
Cowper law overcame Hologic’s Motion for Summary Judgment on the issue of Learned Intermediary.
A list of the recalled devices can be found here: BioZorb Markers and Potential Risks with Use in Breast Tissue: FDA Safety Communication | FDA
Cowper Law specializes in medical device litigation, with a deep understanding of the complexities involved in Biozorb cases. Our firm is dedicated to holding manufacturers accountable and securing the best outcomes for our clients.
Initial consultation to discuss your case
In-depth investigation of the medical device and failure circumstances
Collaboration with top medical experts
Aggressive representation in court to secure the best outcome
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.
Cowper Law investigates cases individually. The attorneys review the medical records in tandem with the applicable state and federal laws in order to determine whether a lawsuit may be filed on your behalf.
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.
“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]
