BioZorb Cancer Implant Recall: Bloomberg Exposes Patient Harm, FDA Failures, and Corporate Negligence

When Bloomberg published its September 3, 2025 feature on the BioZorb cancer implant, it confirmed what many breast cancer survivors and their advocates have been warning for years: this device left a trail of pain, disfigurement, and unanswered questions. At Ketterer, Browne & Davani (KBD), we have been on the front lines of this fight, representing people harmed by BioZorb and helping lead national litigation efforts to hold Hologic accountable.

The Bloomberg investigation, authored by Anna Edney and Tanaz Meghjani, shines a spotlight on how thousands of breast cancer patients were failed—not only by the device’s maker, but by a regulatory system that allowed BioZorb to enter the market without meaningful testing.

A Patient’s Story: When Healing Turned Into Harm

The article opens with the story of Mary Munney Griffiths, a retired administrative assistant from Syracuse, New York. After her breast cancer surgery, she endured two years of relentless pain before doctors finally removed 24 shards of BioZorb plastic from her chest.

Griffiths’ experience is not unique. Patients reported sharp pain, pus-filled infections, blackened tissue, and even mastectomies that might have been avoided if the device had worked as promised. Many say they trusted their doctors, only to discover later that manufacturers had downplayed or delayed reporting known complications.

At KBD, we have spoken to clients with eerily similar experiences. We’ve written extensively about the human toll of defective implants—and BioZorb is one of the clearest examples of how profit-driven decision-making can devastate patients’ lives.

The Corporate Response: Delay, Denial, and Dismissal

One of Bloomberg’s most troubling findings is that hundreds of patient complaints—legally required to be reported to the FDA within 30 days—were withheld for years. It wasn’t until lawsuits began in 2022, and pressure mounted, that the manufacturer disclosed many of these problems.

Even then, the company’s attitude was dismissive. In 2024, after pulling BioZorb from the market, Hologic executives told investors the recall was “more of an administrative” issue and “de minimis” to revenue. For patients like Griffiths, whose bodies and lives have been permanently altered, such language feels like a slap in the face.

KBD has long warned that corporations often minimize safety concerns in order to protect profits. We’ve written about this tactic in other defective medical device cases—and BioZorb is sadly another chapter in the same story.

A Broken System: How BioZorb Got to Market

Bloomberg’s reporting underscores how BioZorb slipped through the cracks of the FDA’s 510(k) clearance pathway—a fast-track process that allows “moderate-risk” devices to be sold if they’re deemed “substantially equivalent” to existing products.

In BioZorb’s case, the “equivalent” devices were small surgical markers, not large dissolvable plastic coils. Yet this was enough for FDA clearance, with no human clinical trials required.

KBD has previously written about the dangers of the 510(k) system, which has put countless devices into patients’ bodies without rigorous testing. Our role in BioZorb litigation is not just about helping clients recover damages—it’s also about pushing for systemic change so these failures don’t repeat.

The Scale of the Problem

According to Bloomberg’s review of FDA data:

• 90,000 breast cancer patients have had BioZorb implanted.

• As of August 2025, the FDA had received 549 formal complaints.

• The true number of women living with complications may be far higher, since not every injury is reported.

For many, removal is not a perfect solution. Griffiths, even after having shards removed, still suffers disfigurement, hardened scar tissue, and lasting pain. For others, removal requires additional invasive surgeries and raises fears of losing their breasts altogether.

At KBD, we’ve heard from women across the country grappling with these same realities. Our legal team has made sure their voices are part of the national conversation—through both court filings and public advocacy.

KBD’s Role in the BioZorb Litigation

Ketterer, Browne & Davani has been deeply involved in BioZorb litigation from the start. Our partner Robert Price serves as Chair of the Science and Experts Committee on the Plaintiffs’ Executive Committee, which leads national coordination of these cases.

This means KBD is not only representing individual clients—we are helping guide the entire strategy that will determine how Hologic is held accountable. We’ve been writing, speaking, and educating about BioZorb for years, and we will continue to stand up for patients who deserve justice.

Why This Matters

Bloomberg’s investigation is a wake-up call. It shows how:

• Patients are left in pain when companies misrepresent their devices.

• Complaints can be buried for years, keeping the public in the dark.

• FDA loopholes allow dangerous products to be sold without testing.

• Corporations profit, even as patients suffer.

At KBD, we believe stories like BioZorb must not fade away once the headlines do. Every patient harmed by this device deserves compensation, accountability, and the reassurance that their suffering won’t be ignored.

What Patients Can Do

If you or a loved one had a BioZorb implant and are experiencing pain, infection, or complications:

1. Seek medical advice immediately — do not ignore ongoing symptoms.

2. Document your experience — keep records of pain, treatments, and surgeries.

3. Contact an experienced law firm — KBD is leading the fight against Hologic and has the expertise to handle complex medical device litigation.

We have already written about the risks of BioZorb, the failures of the FDA’s device approval process, and the corporate indifference patients often face. Now, as this litigation moves forward, we are ready to help survivors seek justice.

Conclusion

Bloomberg’s reporting confirms what patients and lawyers like us at KBD have been saying: BioZorb was marketed as a solution for breast cancer survivors, but it left many with pain, disfigurement, and unanswered questions. The failures were systemic—from a regulatory process that allowed it to market, to a corporation that ignored red flags, to a reporting system that left patients in the dark.

At KBD, we are proud to be at the forefront of this litigation. We’ve written about BioZorb, we’ve warned about its dangers, and now we are working in courtrooms across the country to demand accountability.

If you have been harmed by BioZorb, you are not alone. We encourage you to reach out to us today so we can fight for the justice you deserve.