The BioZorb medical device was implanted in women who underwent lumpectomy procedures to help guide radiation therapy and, as marketed, to support improved cosmetic outcomes. However, numerous patients experienced complications associated with the device. These complications have included chronic pain, infection, device migration, erosion through tissue, swelling or fluid buildup, and the need for additional medical procedures — issues that have been highlighted by regulatory safety communications and a Class I recall.
The U.S. Food and Drug Administration (FDA) issued safety communications and recalls related to BioZorb markers after reports of serious adverse events. These reports noted complications such as infection, device migration, erosion, pain, and other side effects that in some cases required further medical intervention.
Studies and patient reports indicate that the device sometimes did not absorb as intended, leaving the permanent titanium markers in place and leading to unintended outcomes for some patients.
Cowper Law previously filed and pursued BioZorb cases against the manufacturer, contributing to broader legal scrutiny of the device. The cases helped to document the risks patients faced and to hold manufacturers accountable during the period when BioZorb litigation was active. Cowper Law has settled their claims against Hologic and is no longer taking new cases.
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.
Patients and healthcare advocates have raised concerns that the BioZorb implant:
These reports, combined with regulatory notices, underscore why BioZorb implants have become the subject of safety evaluations and legal actions.
Although Cowper Law is not taking new BioZorb cases, understanding the historical context and medical issues tied to this device can help patients and caregivers make informed decisions about their health and engage with healthcare providers about any symptoms or concerns.
If you’re interested in other medical device injury topics or product liability concerns, visit Cowper Law’s broader practice area pages to learn how the firm handles complex litigation and patient advocacy in other contexts.
For additional information about BioZorb recalls, safety notices, and patient experiences, please consult sources such as FDA safety communications on BioZorb markers, and published clinical reports on device performance and complications
“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]
