BioZorb Implant Removal Surgery: What Women Need To Know When the Device Fails To Dissolve

Within several months of a tissue marker recall, hundreds of BioZorb lawsuits have been filed by breast cancer survivors who experienced painful complications that required removal after the device failed to dissolve.

The FDA issued a Class I recall for the BioZorb implant late last year, following reports of painful complications experienced when the tissue marker failed to dissolve as advertised. However, months later breast cancer survivors across the country are still searching for answers about what to do about problems they are experiencing, and what BioZorb removal surgery actually involves.

The BioZorb implant was introduced in the early 2010s as a surgical site marker for breast cancer patients undergoing lumpectomy. Cleared by the FDA as a Class II medical device, it consists of a 3D spiral made from bioabsorbable polylactic acid (PLA), with six embedded titanium clips. The implant is designed to mark the tumor bed and assist radiation oncologists in accurately targeting the treatment area during post-operative therapy.

While the device was intended to gradually dissolve in the body over the course of 12 to 24 months, a growing number of reports suggest that the BioZorb may not fully dissolve in some patients. Instead, the device has been linked to a range of long-term complications that may require additional surgery to remove the implant.

According to adverse event data submitted to the FDA, and experiences outlined in hundreds of BioZorb implant lawsuits filed to date, patients have been left with persistent pain, the formation of palpable masses, chronic inflammation, seromas, localized infections, and in some cases, migration or erosion of the device through the skin. These complications can develop months or even years after the initial lumpectomy.

As more women learn about the FDA’s recalls and safety warnings involving the BioZorb implant, and begin recognizing symptoms of BioZorb failure, many are now seeking answers about what the removal procedure actually involves, and what they may have to endure to find relief from ongoing complications.

In this featured post, AboutLawsuits.com will outline what women need to know if they are experiencing symptoms that may require BioZorb removal. This includes:

• Common signs the BioZorb may not have dissolved
• How doctors diagnose implant-related problems
• Which specialists are typically involved
• What to expect during surgical removal
• Recovery timelines and long-term effects
• Status of BioZorb implant lawsuits

If you have received a BioZorb implant and suffered complications resulting in the removal of the device, or have been told the device needs to be removed, contact a lawyer for a free case evaluation to see if you qualify for a BioZorb lawsuit.

Common Signs a BioZorb May Have Failed

Women who received a BioZorb implant during breast-conserving surgery are often told the device will gradually dissolve on its own over time. However, a growing number of lawsuits and FDA adverse event reports suggest that in many cases, the device remains in the body well beyond the expected absorption period, leading to complications that may require medical intervention.

According to allegations raised in recent product liability claims, some of the most commonly reported symptoms associated with BioZorb failure include:

• Persistent or worsening pain near the lumpectomy site
• A firm or noticeable lump at or near the implant location
• Swelling or fluid buildup (often identified as a seroma)
• Signs of infection, including redness, drainage or warmth around the surgical area
• Implant migration, where the device shifts position inside the breast
• Skin irritation or erosion, in some cases exposing parts of the implant

These symptoms have been reported months or even years after the original surgery, and often lead to confusion or concern for patients, particularly those unaware that the BioZorb implant may still be present.

Lawsuits allege that these problems stem from the device failing to properly dissolve, resulting in ongoing inflammation, tissue irritation or infection. In many of these cases, women ultimately undergo a second surgery to remove the device and relieve their symptoms.

“Plaintiffs were harmed as a result of the BioZorb’s effect on their bodies, suffering complications including, but not limited to, a soft swollen lump, pain, deformity, scarring, sensitivity, seroma, infection, rash, discomfort, non-absorption, and additional surgery.”
—Wheatley et al. v. Hologic, Inc., No. 1:25-cv-11182 (D. Mass. Apr. 30, 2025)

“Following implantation of the BioZorb device, Plaintiff experienced pain, tenderness, and the development of a lump in her breast. She later underwent surgical removal of the device due to ongoing symptoms.”
— Galaini et al. v. Hologic, Inc., No. 1:24-cv-12129 (D. Mass. July 25, 2024)

“Plaintiff experienced severe pain, a hard lump, swelling, and abnormal fluid accumulation, which led to multiple office visits, antibiotic treatments, and continued monitoring.”
— Beth Deuel et al. v. Hologic, Inc., No. 1:24-cv-12129 (D. Mass. Nov. 4, 2024)

These testimonials, drawn directly from court filings, reflect the consistent pattern of injuries alleged by breast cancer survivors who say they were never warned the device might remain intact indefinitely or require surgical removal.

How Doctors Diagnose BioZorb Implant Complications

When patients present with pain or a new lump near the lumpectomy site, the diagnostic process often begins with reviewing their surgical history to determine if a BioZorb was used. Many women are unaware that a device was even implanted—especially if the coil was placed without detailed explanation during cancer treatment.

Once the possibility of a retained BioZorb is established, doctors typically follow a two-part diagnostic approach:

Physical Exam

• Inspection for swelling, scarring or visible protrusion
• Palpation for masses or foreign body sensation
• Assessment for tenderness or localized inflammation

Imaging Studies

• Mammography: Confirms presence of titanium clips; checks for unusual density
• Ultrasound: Detects fluid buildup (seromas), encapsulated inflammation or dense foreign material
• MRI: Highlights soft tissue inflammation and residual PLA material; may use T2-weighted images
• CT Scan (rare): Reserved for suspected chest wall migration or deeper complications

These diagnostic tools not only confirm whether the device is still present but also help assess whether it is contributing to inflammation, nerve irritation or infection—laying the groundwork for referral to a surgical specialist.

Which Specialists Handle BioZorb Removals

BioZorb-related complications can be complex, involving both oncologic and reconstructive considerations. As a result, many patients find themselves consulting multiple specialists before receiving a definitive diagnosis or treatment plan.

Commonly Involved Providers

• Breast Surgical Oncologist: Usually the lead surgeon for removal, especially in cases involving scar tissue or prior radiation
• Plastic/Reconstructive Surgeon: Involved when removal could affect breast contour or symmetry
• Radiologist: Crucial in identifying retained implant material and distinguishing it from tumor recurrence
• Medical Oncologist: May assess whether symptoms are unrelated to cancer progression
• Infectious Disease Specialist (if infection is present): Helps manage cases with abscesses, drainage or systemic inflammation

In many of the lawsuits filed, women allege they were repeatedly told that their pain or swelling was “normal healing,” only to discover much later—often after extensive testing—that the BioZorb had failed to dissolve as expected.

What To Expect During BioZorb Removal Surgery

When a BioZorb implant fails to dissolve or begins to cause pain, swelling or skin changes, surgical removal is often the only effective solution. The complexity of the procedure varies depending on how long the implant has been in place, whether it has migrated or eroded, and whether it has triggered a chronic inflammatory response.

Case reports have outlined procedures for removing a BioZorb, which can include multi-layered surgical steps involving soft tissue dissection, device explantation, and in severe cases, removal of surrounding tissue or skin.

One such case report described a patient who underwent BioZorb placement during lumpectomy for ductal carcinoma in situ (DCIS), only to develop repeated infections and eventual erosion of the device through the nipple-areolar complex. Removal ultimately required surgical debridement and excision of both the device and surrounding breast tissue one year after implantation.

BioZorb Removal Procedure Overview:

• Surgical Access: The surgeon reopens the original lumpectomy site or makes a new incision, depending on the implant’s position and any signs of erosion or infection.
• Device Removal: Dissection is performed through scar tissue to isolate the PLA coil and titanium clips. The implant is gently extracted. In some cases, the BioZorb may have fragmented, requiring removal of embedded pieces.
• Capsulectomy (if needed): A fibrous capsule often forms around the device. If it is inflamed, infected, or structurally distorting the breast, surgeons may remove it entirely.
• Tissue Excision (if erosion occurred): In more severe cases, as seen in the cited report, portions of the overlying skin or even the nipple-areolar complex may need to be excised to eliminate infection or damaged tissue.
• Irrigation and Drain Placement: The surgical pocket is flushed with sterile solution to prevent infection. A drain may be placed to manage fluid buildup and monitor healing.
• Closure: The wound is closed with layered sutures or surgical adhesive, and patients are monitored for signs of infection or seroma during recovery.

Many of the BioZorb lawsuits filed to date have outlined the painful and lengthy surgical procedures plaintiffs were forced to undergo to remove the nonadsorbing implant.

“Plaintiff developed a painful, firm mass at the lumpectomy site, which prompted her surgeon to recommend removal. The surgery involved re-opening the prior incision site, dissecting fibrous tissue, and carefully excising the BioZorb implant, which had not dissolved. She also underwent a partial capsulectomy and placement of a surgical drain to reduce fluid buildup.”
— Tricia Willard et al. v. Hologic, Inc., No. 1:24-cv-10712 (D. Mass. Mar. 29, 2024)

“The BioZorb implant had become encased in inflamed tissue and fragments of the device were found embedded in the breast. Surgical removal required excision of the device and debridement of surrounding tissue. As a result, the plaintiff suffered disfigurement and permanent scarring from the extensive revision surgery.”
— Wheatley et al. v. Hologic, Inc., No. 1:25-cv-11182 (D. Mass. Apr. 30, 2025)

Recovery Timelines and Long-Term Effects

Most women recover from BioZorb removal within a few weeks, but the experience can vary depending on the extent of the surgery and the patient’s medical history. Those who underwent radiation therapy or experienced infection may face longer healing times or more noticeable cosmetic changes.

Short-Term Recovery:

• Pain and swelling typically last 7 to 10 days
• Drains (if used) are usually removed within the first week
• Follow-up visits are scheduled to monitor healing and review any pathology results
• Most women resume normal activities within 2–3 weeks, though full recovery may take longer if complications were present

Potential Long-Term Effects:

• Visible indentation or cosmetic asymmetry in some cases
• Persistent sensitivity or nerve discomfort
• Scarring may be more pronounced in radiated tissue
• Some women may require additional revision surgery for aesthetic correction

While the majority of patients heal without major issues, lawsuits allege that Hologic failed to adequately warn about the potential for retained devices, complications, and the need for surgical removal years later.

2025 BioZorb Implant Lawsuits

As more breast cancer survivors undergo surgery to remove BioZorb implants that failed to dissolve as expected, a growing number are pursuing legal action to hold the manufacturer accountable for injuries they allege could have been avoided.

More than 100 BioZorb product liability lawsuits have already been filed against the manufacturer, Hologic, Inc., each raising similar allegations: that the BioZorb tissue marker was defectively designed, failed to properly absorb in the body, and posed unreasonable risks that patients were never warned about.

To coordinate the growing number of claims, all federal BioZorb lawsuits have been consolidated before Judge Allison D. Burroughs in the U.S. District Court for the District of Massachusetts, where Hologic is headquartered.

In March 2025, Judge Burroughs appointed a group of seven attorneys to serve in leadership roles for plaintiffs, forming a Plaintiffs’ Executive Committee (PEC) responsible for coordinating discovery and potential global settlement discussions.

Later that month, the court issued a key ruling rejecting Hologic’s motion to dismiss the design defect claims. In her opinion, Judge Burroughs found that the plaintiffs had sufficiently alleged that the BioZorb’s unique combination of shape, surface texture and polylactic acid material may prevent the device from properly dissolving, potentially causing it to migrate, erode, or trigger chronic infections. The court also noted that plaintiffs plausibly argued safer alternative designs existed, referencing older tissue markers that did not carry the same risks.

The litigation is now moving toward a series of early “bellwether” trials, which will involve a small group of representative cases selected to go before juries. The first trial is scheduled to begin on September 8, 2025, with a second case set for January 20, 2026. While these trials will not determine the outcome of other claims, they are expected to influence how future BioZorb lawsuit settlements may be valued.

Still Time To File a BioZorb Lawsuit

Women who received a BioZorb implant and later developed complications may still have time to file a claim. However, state laws limit the time individuals have to pursue compensation through statutes of limitations.

It is crucial that women who underwent revision surgery, or are now experiencing painful symptoms act quickly to protect their rights.

Compensation may be available for:

• Lost wages or diminished quality of life
• Medical costs related to removal and follow-up care
• Pain and suffering
• Emotional trauma
• Physical disfigurement or mastectomy

If you received a BioZorb implant and later experienced complications requiring removal—or have been advised that the device must be surgically removed—you may be entitled to financial compensation.

Contact a BioZorb lawyer today for a free case evaluation and to see if you qualify for a lawsuit.