Breast Mesh Explant Surgery: Why Complications from GalaFLEX or Internal Bra Mesh May Result in Breast Implant Removal

What Is Breast Mesh Explant Surgery?

Breast mesh explant surgery is a procedure to remove surgical mesh that was placed inside the breast during reconstruction, augmentation, breast lift or revision surgery.

In recent years, products like GalaFLEX and Phasix have been used during many of these procedures as an “internal bra” to reinforce tissue, support implants or help maintain breast shape. However, no surgical mesh product has been FDA-approved or cleared for use in breast surgery, and lawsuits allege that women were not adequately warned about the risks of placing these synthetic mesh products in the breast.

The potential impact is significant. In 2024 alone, the American Society of Plastic Surgeons reported more than 306,000 breast augmentation procedures, more than 153,000 breast lift procedures and more than 162,000 breast reconstruction procedures in the United States. Public data does not show how many of these women received GalaFLEX or Phasix mesh, but synthetic mesh has been heavily adopted in these types of procedures for internal support.

Synthetic Breast Mesh Reoperation and Explant Rates

The need for breast mesh explant or revision surgery has become a serious concern for women who experience complications after synthetic mesh is used in breast reconstruction. A 2024 systematic review and meta-analysis of 31 studies involving synthetic mesh in alloplastic breast reconstruction reported the following pooled complication rates:

• Reoperation: 10%
• Explantation: 3%
• Infection: 4%
• Seroma: 3%

For some women, explant surgery is a single corrective procedure. For others, it becomes part of a longer process involving infection treatment, wound care, delayed reconstruction or multiple revision surgeries.

Why Breast Mesh May Need to Be Removed

Breast mesh may need to be removed when complications cannot be resolved with medication, drainage, observation or other conservative treatment. In many cases, removal is not simply a cosmetic decision. It may be necessary because the mesh has failed, shifted, become infected, caused pain or interfered with the implant pocket.

The FDA’s MAUDE database collects medical device reports submitted by manufacturers, importers, device user facilities, healthcare professionals, patients and consumers. These reports do not prove causation by themselves, but they provide real-world examples of breast mesh side effects and complications experienced by women nationwide.

MAUDE reports involving GalaFLEX products describe several scenarios where mesh removal, explant surgery or revision surgery was reported, including:

• Infections involving the mesh or implant pocket, including reports where GalaFLEX mesh was removed after a breast infection or suspected infection affected the mesh.
• Abscess, pus, or severe infection requiring surgery, including reports where the breast pocket was opened and infected material was found around the mesh.
• Seroma or persistent fluid buildup, including reports where surgeons opened the breast pocket expecting hematoma but found significant serous yellow fluid and removed both GalaFLEX meshes.
• Hematoma or blood collection, including reports where patients developed hematoma after GalaFLEX placement and required drainage, evacuation or additional surgery.
• Wound dehiscence or incision breakdown, including reports where patients developed bilateral wound dehiscence and underwent removal of both implants and GalaFLEX 3D mesh.
• Skin necrosis or tissue breakdown, including reports involving necrosis, skin breakdown or impaired healing after GalaFLEX placement.
• Palpable mesh or mesh felt through the skin, including reports where the mesh could be felt, caused tenderness or was described as rolled and felt through the skin, leading to recommended removal or revision surgery.
• Mesh rolling, folding, shrinking or wadding up, including reports where GalaFLEX was described as folded, shriveled, rolled or “wadded up,” requiring removal or revision.
• Bottoming out, ptosis or loss of implant support, including reports where patients experienced implant dropping, bottoming out or recurrent ptosis after GalaFLEX placement, leading to revision or planned removal.
• Failure to integrate with tissue, including reports where GalaFLEX had not incorporated into the patient’s tissue, did not dissolve as expected or dehisced from the pectoralis muscle.
• Implant rupture or implant failure, including reports where a ruptured breast implant and mesh were removed, or where device rupture was reported with breast asymmetry.
• Foreign body reaction or suspected rejection, including reports where fever, pocketing, infection or possible mesh rejection led to removal or excision of GalaFLEX mesh.

Together, these reports show why breast mesh explant surgery may become necessary. When GalaFLEX mesh is painful, infected, displaced, folded, exposed, poorly incorporated or involved in a failed reconstruction, surgeons may need to remove the mesh, remove or replace the implant, drain fluid or blood, repair damaged tissue, and rebuild the breast pocket.

Steps Involved in Breast Mesh Explant Surgery

The exact procedure depends on the complication, the type of implant, how much scar tissue has formed, whether infection is present and whether the patient wants another reconstruction. In general, breast mesh explant surgery may involve several steps.

Preoperative Evaluation

Before breast mesh explant surgery, the surgeon may review operative reports, implant records, prior pathology, infection history, symptoms and any available imaging. The goal is to understand what product was used, where it was placed, whether the implant is intact and what complications may need to be addressed during surgery.

Depending on the symptoms, doctors may order imaging or testing before surgery. This may include:

• Ultrasound, to evaluate swelling, seroma, abscess, hematoma or other fluid around the implant or mesh.
• MRI, especially when silicone implant rupture is suspected, since the FDA identifies MRI as the most effective method for detecting silent rupture of silicone gel-filled breast implants. Ultrasound is also an acceptable alternative for rupture screening in asymptomatic patients.
• Mammogram or breast imaging, when doctors need to evaluate breast tissue, implant position or other abnormalities.
• Bloodwork or cultures, if infection, abscess or drainage is suspected.

The surgeon will usually want to know:

• Which mesh product was implanted
• Where the mesh was placed
• Whether the implant is intact
• Whether there is fluid, infection or tissue damage
• Whether the mesh is palpable, folded, migrated or detached
• Whether the patient wants implant replacement or complete removal

Reopening the Surgical Pocket

During surgery, the surgeon usually reopens the prior incision if possible. The location may depend on the original surgery and the complication. The incision may be under the breast fold, around the areola, through a mastectomy scar or along a prior revision incision.

Once the pocket is opened, the surgeon evaluates the mesh, implant, capsule, scar tissue, fluid and surrounding tissue.

Removing the Mesh

Mesh removal may be straightforward if the material is loose, detached or not integrated. However, it can be more difficult if the mesh has become incorporated into scar tissue or attached to surrounding tissue.

The surgeon may need to carefully dissect the mesh away from the breast pocket, chest wall, capsule or lower breast tissue. If the mesh is folded, rolled, hardened, exposed or wadded up, removal may require additional tissue release and reconstruction of the pocket.

Removing or Replacing the Implant

In many explant cases, the breast implant may also need to be removed. This may occur when there is infection, rupture, severe displacement, wound breakdown, capsular problems, tissue necrosis or reconstructive failure.

Some women may choose immediate implant replacement. Others may need delayed reconstruction, especially if infection or tissue damage is present. In severe cases, the safest option may be to remove the implant and mesh and allow the breast to heal before deciding on future reconstruction.

Draining Fluid or Blood

If a seroma or hematoma is present, the surgeon may drain the fluid or blood collection. The pocket may be irrigated, cultures may be taken if infection is suspected, and drains may be placed to reduce the risk of recurrent fluid buildup.

Repairing the Breast Pocket

If the mesh failed because of bottoming out, migration or loss of support, the surgeon may need to rebuild the breast pocket. This may involve tightening the capsule, repairing the inframammary fold, repositioning the implant pocket, removing scar tissue or using sutures to restore support.

This is often one of the most important parts of the procedure because simply removing the mesh may not correct the deformity. The surgeon must also address the structural failure that caused the breast or implant to shift.

Treating Dead or Damaged Tissue

If skin necrosis, tissue breakdown or wound dehiscence occurred, the surgeon may need to remove dead tissue, clean the wound and close the incision in a way that promotes healing. In some cases, reconstruction must be delayed because the tissue is not healthy enough to support another implant.

Recovery After Breast Mesh Explant Surgery

Breast mesh explant surgery can be physically and emotionally difficult because it often occurs after a patient has already gone through one or more breast surgeries.

Recovery depends on what had to be done during surgery. A simple mesh removal may involve a shorter recovery, while removal with implant exchange, pocket reconstruction, infection treatment or tissue repair may require a longer healing period.

Women may experience:

• Breast pain, tightness or soreness
• Swelling and bruising
• Drain placement
• Limited arm movement
• Numbness or nerve sensitivity
• Temporary asymmetry
• Wound care needs
• Restrictions on lifting, exercise and sleeping position
• Follow-up visits to monitor healing

Some women may need weeks to return to normal activity, especially if drains are used or if both breasts are treated. If infection, necrosis or wound breakdown is involved, recovery may take longer and may require antibiotics, wound care or additional procedures.

Can Mesh Be Removed Without Removing the Implant?

Sometimes, yes. However, it depends on why the mesh is being removed.

If the mesh is painful, palpable or displaced but the implant is intact and the pocket is otherwise healthy, a surgeon may consider removing or revising the mesh while preserving the implant. However, implant removal may be necessary when there is:

• Infection
• Abscess
• Implant rupture
• Severe displacement
• Wound dehiscence
• Skin necrosis
• Persistent seroma
• Reconstructive failure
• Mesh exposure
• Severe pain or tissue damage

In infected cases, doctors may remove both the mesh and implant because leaving foreign material in place can make it harder to clear the infection.

What Symptoms May Indicate Breast Mesh Removal Is Needed?

Women who received GalaFLEX or other internal bra mesh should speak with a doctor if they experience new or worsening symptoms, especially months or years after surgery.

Concerning symptoms may include:

• Persistent breast pain
• Burning, tingling or nerve-like pain
• A hard lump or palpable mesh edge
• Redness, warmth, swelling or drainage
• Recurring fluid buildup
• Sudden breast swelling or bruising
• Breast asymmetry or bottoming out
• Implant shifting or falling to the side
• Visible rippling, distortion or deformity
• Skin thinning, darkening or open wounds

These symptoms do not automatically mean a lawsuit is available, but they may warrant medical evaluation and legal review if GalaFLEX or Phasix mesh was involved.

Why Medical Records Matter

Women who suspect breast mesh complications should try to obtain their medical records. The most important documents may include:

• Operative reports
• Implant stickers or device records
• Mesh product labels
• Postoperative visit notes
• Imaging reports
• Culture results
• Emergency room records
• Revision surgery records
• Explant pathology or operative findings
• Photographs of wounds, swelling or deformity

These records can help determine which product was used, when complications began, whether the mesh was removed, and what the surgeon found during revision surgery.

Financial Costs of Failed Breast Mesh

The financial cost of failed breast mesh can be substantial, especially when women are forced to undergo additional testing, specialist visits, explant surgery or revision procedures after their original reconstruction or augmentation.

In many cases, the woman already paid for one breast procedure and then discovers that the mesh used to support the implant has failed, shifted, become painful, caused infection or contributed to a failed reconstruction. At that point, she may be left paying for a second round of medical care that was never expected when the mesh was first implanted.

These costs may include:

• Imaging scans, including ultrasound, MRI, mammogram or other breast imaging
• Bloodwork, cultures or infection testing
• Follow-up visits with plastic surgeons or breast specialists
• Emergency care for swelling, infection, hematoma or wound breakdown
• Drainage procedures for seroma or hematoma
• Antibiotics, wound care or pain management
• Explant surgery to remove the failed mesh
• Implant removal or replacement
• Breast pocket repair or reconstruction revision
• Treatment for scarring, deformity or tissue damage
• Lost wages during surgery and recovery
• Travel costs for medical appointments or specialist care

Insurance may not cover all of these costs. Some women may be told that revision surgery is cosmetic, even when the procedure is needed because of pain, infection, implant displacement, rupture, tissue damage or reconstructive failure. Others may face deductibles, co-pays, out-of-network bills, denied claims or expenses for procedures needed to correct the damage caused by failed breast mesh.

For women who require explant or revision surgery, the financial impact can continue long after the mesh is removed. Recovery may involve weeks away from work, repeated follow-up appointments, drains, wound care, imaging, additional procedures and uncertainty about whether another reconstruction will be successful.

Breast mesh lawsuits seek to hold manufacturers accountable for these losses when women were not adequately warned about the risks of synthetic mesh used in breast surgery. A claim may seek compensation for medical bills, future treatment, lost income, pain and suffering, scarring, disfigurement, emotional distress and the cost of additional surgery needed to correct the failed mesh procedure.

Speak With a Breast Mesh Lawyer

Breast mesh revision or explant surgery can leave women facing additional pain, medical expenses, scarring, emotional distress and uncertainty about future reconstruction. For many women, the need for another surgery is not just a cosmetic issue. It may be the result of a serious complication involving an implanted medical device.

Saiontz & Kirk is investigating breast mesh lawsuits for women who received GalaFLEX or Phasix mesh and later required removal surgery, revision surgery or other corrective treatment.

Call 1-800-522-0102 or complete the form on this page to schedule a free consultation. There are no fees or expenses unless a settlement or recovery is obtained.

SPEAK WITH A BREAST MESH LAWYER TODAY

Breast Mesh Explant Surgery FAQs

What is breast mesh explant surgery?

Breast mesh explant surgery is a procedure to remove surgical mesh that was previously placed inside the breast during reconstruction, augmentation, lift or revision surgery. The procedure may also involve removing or replacing the breast implant, draining fluid, repairing tissue damage or correcting implant displacement.

Why would GalaFLEX mesh need to be removed?

GalaFLEX mesh may need to be removed if it becomes painful, palpable, displaced, folded, infected, exposed or involved in reconstructive failure. Some women report that the mesh rolled, detached, failed to provide support or contributed to the need for revision surgery.

Is breast mesh removal the same as breast implant removal?

No. Breast mesh removal focuses on taking out the internal support mesh. Breast implant removal involves taking out the implant itself. However, both procedures may be performed together if the implant is infected, ruptured, displaced or involved in a failed reconstruction.

What complications may lead to breast mesh explant surgery?

Complications that may lead to breast mesh explant surgery include infection, abscess, seroma, hematoma, mesh migration, displacement, skin necrosis, implant rupture, nerve damage, chronic pain and reconstructive failure.

How painful is breast mesh explant surgery?

Pain varies by patient and depends on how complicated the removal is. Women may experience soreness, swelling, bruising, nerve sensitivity and limited movement during recovery. More complex cases involving infection, scar tissue, implant replacement or tissue repair may involve a longer and more painful recovery.

Can breast mesh be removed if it has grown into tissue?

In some cases, yes. However, removal may be more complex if the mesh has become incorporated into scar tissue or attached to surrounding tissue. The surgeon may need to carefully dissect the mesh away from the pocket, capsule or breast tissue.

Does the FDA recommend removing breast mesh?

The FDA has said it is not recommending reoperation or removal of implanted surgical mesh in patients who do not have symptoms. However, women with pain, infection, fluid buildup, implant failure or other complications should speak with their doctors about appropriate treatment options.

Can I file a lawsuit if I had breast mesh removed?

A lawsuit may be available for some women who received GalaFLEX or Phasix mesh and later required explant surgery, revision surgery or other corrective treatment. Eligibility depends on the product used, the timing of symptoms, the injuries suffered and the medical records documenting the complication.