Lawsuit Alleges BioZorb Removal Surgery Likely Needed After Breast Tissue Marker Failed To Reabsorb

According to allegations raised in a product liability lawsuit filed late last month, a Pennsylvania woman who already survived breast cancer may now have to undergo additional surgery after her BioZorb tissue marker failed to absorb back into her body, forming a hardened and painful mass in her left breast.

BioZorb is a small implant approved for use among breast cancer survivors and other individuals who require targeted radiation therapy, which consists of a biodegradable spacer made from polylactic acid, and six permanent titanium clips. The implant is designed to gradually break down and dissolve in the body, leaving only the clips in place to aid in the precise marking of previous surgical tumor removal sites.

In a complaint (PDF) brought in the U.S. District Court for the District of Massachusetts on September 30, Laura Nudel indicates that she still has a non-absorbed marker in her left breast, which will likely require future surgery to remove the BioZorb, and possibly removal of her entire breast, due to the pain and scarring.

She joins a growing number of breast cancer survivors now pursuing BioZorb lawsuits against Hologic, Inc., the manufacturer of the device, alleging that the tissue marker was sold in a defective condition, with inadequate warnings about the risk of side effects BioZorb may cause patients to experience.

According to her lawsuit, Nudel was diagnosed with breast cancer in August 2021 and underwent a lumpectomy in her left breast the next month. At that time a BioZorb marker was implanted in her breast.

“Plaintiff suffered from injuries at and around the site of the BioZorb device,” the lawsuit states. “Plaintiff suffers from a hardened mass and scar tissue near the site of the implantation of the BioZorb and can ‘feel’ what she believes is likely the non-absorbed device in her left breast.”

The lawsuit indicates Nudel has been diagnosed with scar tissue and fat necrosis at the implant site. She has suffered from severe pain, reddening and a hot burning sensation in her breast tissue for more than a year.

As a result of the complications, Nudel believes she will need additional treatment for pain and will likely need BioZorb removal surgery, or she could lose her entire left breast, the lawsuit notes.

She presents claims of strict liability, negligent failure to warn, negligent design defect, breach of implied warrant, negligence, and seeks compensatory and punitive damages.

BioZorb Removal Lawsuits

Given similar allegations and claims presented in complaints filed against Hologic, Inc. in the U.S. District Court for the District of Massachusetts, where the manufacturer’s headquarters are located, all lawsuits over BioZorb implants have been consolidated before U.S. District Judge Allison D. Burroughs for coordinated discovery and pretrial proceedings.

In July, Judge Burroughs directed the parties to select a group of BioZorb lawsuits for a bellwether process, with each side designating five cases for a Discovery Pool. Those BioZorb injury cases will go through depositions, exchange of medical records and other case-specific discovery, which must be completed by December 16, 2024.

After discovery is complete in the bellwether BioZorb lawsuits, each side will be able to strike three cases from the pool, leaving a total of four claims that will be eligible to go before the first juries in or around July 2025.

While the outcome of any early trial dates will not have any impact on other claims being pursued against the manufacturer, the amounts of any payouts awarded by juries are likely to have a substantial impact on BioZorb implant settlement negotiations needed to avoid each claim ultimately being set for trial in the future.