BioZorb Lawsuit Alleges Breast Tissue Marker Failed, Requiring Surgical Removal

A group of breast cancer survivors have filed a joint BioZorb lawsuit against Hologic, Inc., indicating that the implantable breast tissue marker contains a defective design that may cause the device to fail or migrate, resulting in severe pain, infections or the need for additional surgery to remove the device from their body.

BioZorb is an implanted device commonly used for medical imaging during breast cancer treatments, which consists of a biodegradable spacer made from polylactic acid, and six permanent titanium clips. It is intended for the device to gradually break down and dissolve in the body, leaving the clips in place to aid in the precise marking of areas where a tumor has been surgically removed, to provide a clear target for radiation treatments.

The device has been marketed as a safe and effective option for breast cancer patients, providing a critical guide for targeted radiation therapy to eliminate of any remaining cancer cells, while protecting the surrounding healthy tissue. However, a growing number of reports have been submitted to the manufacturer and FDA, involving painful complications where the device moved, fractured or failed to absorb back into the body, resulting in the need for surgical interventions.

As a result of these problems, a BioZorb recall was issued earlier this year, and a rapidly growing number of product liability lawsuits are now being filed against the manufacturer.

In a recent complaint (PDF) filed in the U.S. District Court for the District of Massachusetts, Shellie Broeder, Amy Delgado, Marisa Sayers, Michelle Martinez, and Anita Mendiola joined together to pursue product liability claims against the device manufacturer, Hologic, Inc., each raising similar allegations that there were known design defects associated with the BioZorb marker that caused various different injuries.

BioZorb Marker Fracture and Migration Claim

Marisa Sayers claims that she encountered severe complications when her BioZorb Marker implant not only failed to dissolve, but actually fractured and migrated throughout her breast tissue.

She alleges that the BioZorb Marker failed due to an unreasonably dangerous and defective design, causing her to experience a stabbing sensation and severe discomfort from the fractured device. This effected her daily life, making it difficult to lay down or perform daily activities until the device was surgically removed.

BioZorb Failure to Dissolve Claims

Shellie Broeder claims she experienced intense pain that led to the surgical removal of the BioZorb Marker, after her device also failed to dissolve as intended. The constant discomfort and the fear of cancer recurrence caused her significant emotional distress and permanent physical scarring.

Similarly, both Michelle Martinez and Anita Mendiola also experienced significant issues with the BioZorb Marker failing to dissolve. Martinez suffered from a hard, painful lump at the implant site, which led to discomfort, irritation, and breast deformity. Mendiola states that she had severe discomfort when the undissolved BioZorb began protruding through her skin, causing intense pain and necessitating further medical interventions to remove the device.

Infection From BioZorb Marker

Amy Delgado claims she experienced severe pain and infections from the BioZorb Marker, after the device implanted in her body failed to dissolve and migrated out of position. This led to disfigurement and necessitated additional surgery to remove the device, highlighting significant infection risks associated with BioZorb.

Each of the plaintiff’s claims highlight a series of potential defects and undisclosed side effects caused by the BioZorb Marker, ranging from non-absorption and physical migration, to serious infections.

The joint lawsuit presents claims for negligence, including failure to warn and design defects, as well as breaches of implied warranty of merchantability, asserting that Hologic failed to adequately inform or protect patients from the known risks associated with the BioZorb Marker.

July 2024 BioZorb Marker Lawsuit Update

The case will be centralized with a number of other BioZorb lawsuits that are currently pending against Hologic, Inc. in the District of Massachusetts, where the manufacturer’s headquarters are located. Since each of those claims involve nearly identical questions of fact and law, the litigation in that federal district has been assigned to U.S. District Judge Allison D. Burroughs for coordinated discovery and pretrial proceedings.

As part of the management of the growing BioZorb marker litigation, Judge Burroughs has established a bellwether plan, where a small group of cases are being prepared for early trial dates to help the parties gauge how juries may respond to certain evidence and testimony that could be repeated in numerous claims.

The Court has established detailed guidelines for how discovery disputes will be handled, and procedures for the exchange of medical records and other documentation, ensuring that the litigation proceeds in an orderly and fair manner.

Although the outcome of these early trial dates will not have any binding impact on other breast cancer survivors pursuing lawsuits against BioZorb manufacturers, the average amounts any lawsuit payouts may influence how much Hologic pays as part of any BioZorb settlement agreement to avoid each individual claim going before a jury in the future.

As the early discovery proceeds in those bellwether claims, BioZorb injury lawyers are continuing to investigate and review lawsuits for individuals that have suffered injuries from the device failing to dissolve, fracturing or migrating.