Internal Bra Complications: Signs, Symptoms & What to Do

The internal bra breast lift technique involves placing a supportive mesh material beneath the breast tissue to create a permanent internal support structure that mimics the function of a push up bra.

A board certified plastic surgeon developed this approach to address sagging breasts and maintain the position of implants or natural tissue in cases where a regular breast lift would not provide lasting results.

During the procedure, the surgeon attaches the mesh scaffold to the chest wall along the inframammary fold (the crease where the breast meets the torso) to provide extra support.

The internal bra offers soft tissue support and structural reinforcement to the lower pole and upper pole of the breast pocket while the body’s natural collagen formation eventually integrates with the material over a period of 12 to 18 months.

Types of Biologic and Synthetic Meshes Used in Internal Bra Procedures

Two primary categories of internal mesh materials have been used in internal bra procedures: biologic matrices derived from human or animal tissue and synthetic meshes made from absorbable or non-absorbable polymers.

The choice of mesh materials often depends on the specific surgical application, patient characteristics, and surgeon preference.

Four primary mesh materials have been deployed in internal bra procedures:

• Human-derived acellular dermal matrix (ADMs) include products such as AlloDerm, AlloMax, FlexHD, and DermaMatrix, which are processed from donated human tissue with cells removed while leaving the collagen scaffold intact.
• Animal-derived ADMs derive from Strattice (porcine), SurgiMend (bovine), and Permacol, which undergo processing to remove cellular components and fatty tissue while preserving the structural framework.
• Absorbable mesh products like GalaFLEX, Phasix, TIGR Matrix, and Vicryl are designed to dissolve over time as the body replaces them with natural scar tissue.
• Non-absorbable synthetic meshes including TiLOOP Bra and SERAGYN BR remain permanently in the body after implantation.

These materials vary in their integration with surrounding breast tissue, their potential for complications over time, and their impact on aesthetic outcomes.

Identifying which specific mesh product was used during surgery is often a key factor in determining eligibility for legal action.

Why Breast Mesh Implants Are Used in Breast Augmentation and Reconstruction

Surgeons began incorporating mesh into breast procedures to provide additional tissue reinforcement for weak breast tissue and implant support that a traditional breast lift alone could not achieve.

The mesh allows plastic surgeons to accomplish results that would otherwise require mobilizing substantial amounts of the patient’s own tissue.

Surgeons incorporate mesh into breast procedures for the following applications:

• Mesh extends the coverage provided by the pectoralis major muscle during implant based breast reconstruction following mastectomy, helping breast cancer survivors achieve reconstruction.
• The material provides additional internal support to create and stabilize the inframammary fold position, preventing the breast from dropping too low over time (essentially acting as a permanent invisible bra).
• Internal bra placement addresses implant bottoming out and malposition by providing structural support to the implant pocket and maintaining proper positioning.
• Direct-to-implant alloplastic breast reconstruction using mesh eliminates the need for tissue expanders and multiple surgical procedures in some patients.
• Breast lift surgery, known as mastopexy, utilizes mesh for lower pole support to improve shape and enhance the longevity of results, particularly in patients with excess skin following weight loss surgery or other weight changes.

Despite these intended benefits, the FDA has not approved any mesh products specifically for cosmetic breast surgery or reconstructive surgery applications, meaning these uses remain off-label with unverified safety profiles.

If you or a loved one received a breast mesh implant and experienced complications, you may have legal options to pursue compensation for your injuries.

Contact TruLaw using the chat on this page to receive an instant case evaluation and learn whether you qualify to file a Breast Mesh lawsuit today.

The FDA has taken an increasingly firm stance on the use of mesh in breast procedures, issuing multiple communications warning health care providers and patients about the risks.

These regulatory actions have highlighted the lack of formal approval for mesh use in breast surgery and raised concerns about manufacturers’ marketing practices.

November 2023 FDA Letter to Health Care Providers

In November 2023, the FDA issued a direct communication to health care providers regarding BD mesh products used in breast procedures.

This letter underscored the agency’s position that surgical mesh has not been evaluated for safety or effectiveness in breast-specific applications.

The FDA’s November 2023 communication addressed several key regulatory points:

• The FDA confirmed that no surgical mesh product has been cleared or approved for use in breast augmentation, reconstruction, or lift procedures.
• BD was required to update its product labeling to clearly state that these devices have not been studied for breast surgery use.
• Health care providers were advised to follow updated instructions for use and carefully consider the unapproved nature of breast applications.
• The agency encouraged reporting of adverse events through the MedWatch program to help identify potential safety signals.

This communication represented a regulatory action that has provided enhanced support for ongoing legal claims against mesh manufacturers.

Off-Label Marketing Concerns and Citizen Petitions

Allegations have emerged that mesh manufacturers actively promoted their products for breast surgery despite lacking FDA approval for these specific uses.

The distinction between cleared indications and actual marketing practices forms a central basis for current litigation.

The distinction between cleared indications and actual marketing practices includes these allegations:

• Most mesh products received FDA clearance through the 510(k) pathway for general soft tissue repair rather than breast-specific indications.
• Marketing materials and promotional activities allegedly suggested or encouraged use of these devices for breast augmentation and reconstruction.
• Manufacturer-sponsored clinical studies have been characterized as tools for promoting off-label applications to plastic surgeons.
• Citizen petitions filed with the FDA requested regulatory action to address perceived gaps in device oversight and marketing restrictions.

The 510(k) clearance process only requires demonstration of substantial equivalence to an existing product rather than proof of safety and effectiveness for specific applications like breast surgery.

If you or a loved one received a breast mesh implant and experienced complications, you may have legal options to pursue compensation for your injuries.

Contact TruLaw using the chat on this page to receive an instant case evaluation and learn whether you qualify to file a Breast Mesh lawsuit today.

Clinical literature and FDA adverse event reports have documented a range of complications following internal bra procedures using surgical mesh.

Differing complication rates emerge depending on the type of mesh used, patient factors, and the specific surgical technique employed.

Infection, Seroma, and Hematoma Rates

Fluid-related and infectious complications represent some of the most frequently reported problems following breast mesh surgery.

These issues often require additional medical intervention and can compromise the overall surgical outcome.

Documented complication rates from clinical literature reveal the following patterns:

• Infection rates in breast mesh procedures range from 3.6% to 8.9% depending on the type of mesh implanted and patient health factors.
• Seroma formation (the accumulation of fluid in the surgical site) occurs in approximately 4.8% to 14.1% of patients receiving mesh implants and can lead to delayed wound healing.
• Hematoma rates of roughly 2.2% and wound dehiscence complications have been documented, with some cases requiring surgical drainage or revision.
• FDA analysis found a significant difference in complication rates, with FlexHD and AlloMax associated with higher infection and surgical failure rates compared to other brands.

Factors that increase risk include the specific mesh material, pre-existing health conditions, and variations in surgical technique among different types of providers.

Capsular Contracture and Mesh Migration

The formation of scar tissue around mesh and implants can lead to hardening, distortion, and displacement of breast contour over time.

Mesh migration occurs when the material shifts from its original placement, potentially causing tissue erosion or implant malposition.

Long term complications from mesh placement present in several ways:

• Capsular contracture rates in mesh-assisted breast procedures range between 2.5% and 14.8% based on various clinical studies.
• Mesh migration and implant displacement can cause breast implants to drop too low, shift to one side, or rotate out of proper alignment.
• Tissue erosion may occur when displaced mesh wears through the surrounding tissue, sometimes protruding through the skin.
• Breast augmentation revision surgery is often required to correct these complications, with some patients needing multiple additional procedures.

Long term monitoring of synthetic mesh outcomes remains necessary for patients with breast mesh implants used in reconstruction, augmentation, or other breast surgeries, as complications can develop months or even years after the initial surgery.

Recognizing the warning signs of mesh complications enables patients to seek medical attention before problems worsen.

Early detection and treatment can help prevent lasting damage and improve outcomes for breast lift patients and other affected individuals.

Physical Warning Signs to Watch For

Specific physical symptoms may indicate that mesh complications have developed following internal bra surgery.

Patients should remain vigilant for these warning signs and report any concerns to their healthcare provider promptly.

Patients should monitor for these physical indicators of mesh complications:

• Elevated temperature or fever may indicate infection developing at the surgical site or around the mesh implant.
• Redness, swelling, or warmth in the breast area suggests inflammation or possible infectious complications requiring evaluation.
• Severe or persistent pain in the breast that does not improve with time warrants medical assessment to determine the underlying cause.
• Discharge from incision sites or the nipple may signal infection, mesh erosion, or wound breakdown.
• Visible changes in breast shape including breast sagging, position changes, or breast asymmetry could indicate mesh migration or implant malposition.
• Hardening of breast tissue may represent capsular contracture developing around the mesh or implant.

These symptoms may appear immediately after surgery or develop gradually over months to years as the mesh integrates or fails within the body.

When to Seek Medical Attention

Certain circumstances following internal bra surgery require immediate medical evaluation to prevent serious complications.

Patients should not hesitate to contact their healthcare provider or seek emergency care when concerning symptoms arise.

Immediate medical evaluation becomes necessary when experiencing any of these conditions:

• Signs of infection including fever, redness, swelling, or purulent discharge demand prompt medical assessment and treatment.
• Sudden onset or worsening pain that differs from normal post-surgical discomfort requires evaluation to rule out serious complications.
• Noticeable changes in breast appearance or position should be reported to determine whether mesh migration or failure has occurred.
• General feelings of illness, fatigue, or malaise following mesh surgery may indicate systemic problems requiring attention.
• Any concerns about implant rupture or mesh integrity warrant discussion with the surgical team to assess device status.

The FDA encourages both patients and healthcare professionals to report adverse events related to breast mesh through the MedWatch program to help identify safety issues affecting other patients.

If you experienced any of these symptoms following internal bra surgery with mesh, you may be entitled to compensation for your medical expenses and suffering.

Contact TruLaw using the chat on this page to receive an instant case evaluation that can help you determine if you qualify to join others in filing a Breast Mesh lawsuit today.

Several medical device manufacturers currently face legal scrutiny for their internal bra mesh products.

Plaintiffs allege these companies marketed devices for unapproved uses and failed to adequately warn about known risks associated with breast surgery applications.

GalaFLEX, Phasix, and BD Mesh Products

The NJ medical firm Becton, Dickinson and Company (BD) manufactures both GalaFLEX mesh and Phasix mesh products that have been widely adopted in internal bra procedures.

Following FDA action in November 2023, BD updated its labeling to state that these devices have not been studied for use in breast reconstructive surgery.

BD’s mesh products have come under scrutiny for the following reasons:

• GalaFLEX is an absorbable synthetic mesh marketed for soft tissue reinforcement that dissolves over 12 to 18 months as collagen replaces the scaffold.
• Phasix mesh uses a similar absorbable polymer technology that has been promoted for various surgical applications including breast procedures.
• Lawsuits allege BD promoted these products for breast surgery despite lacking FDA approval for these specific indications.
• The company’s labeling now includes warnings about the unverified nature of breast-specific applications following FDA intervention.

These products remain available for their cleared indications in general soft tissue repair while litigation proceeds regarding alleged off-label promotion.

AlloMax, FlexHD, and Other ADM Products

Acellular dermal matrix products from multiple manufacturers have also been implicated in breast mesh litigation.

FDA analysis identified higher rates of complications associated with certain ADM brands compared to others.

FDA analysis identified elevated complication rates with specific ADM brands:

• AlloMax, produced by C.R. Bard (now part of BD), showed elevated rates of explantation, reoperation, and infection in FDA analysis compared to other ADM products.
• FlexHD from MTF Biologics demonstrated similar patterns of increased complications requiring surgical intervention in clinical studies.
• Both products were associated with higher failure rates at the two-year mark compared to SurgiMend and AlloDerm brands in FDA evaluation.
• Legal claims against these manufacturers allege failure to warn about documented risks and promotion for unapproved breast surgery uses.

Affected patients who received these specific products may have particularly strong grounds for legal claims based on FDA findings regarding comparative complication rates.

If you or a loved one suffered complications from an internal bra procedure involving surgical mesh, you may have legal options to pursue compensation.

Contact TruLaw using the chat on this page to receive an instant case evaluation and determine whether you qualify to file a Breast Mesh lawsuit today.

Individuals who underwent internal bra surgery with mesh and subsequently experienced complications may be eligible to pursue legal claims against device manufacturers.

The strength of potential claims depends on documented injuries, medical treatment records, and the specific circumstances of each case.

Eligibility Criteria for Internal Bra Litigation

General requirements for filing a breast mesh lawsuit include having undergone the procedure and experiencing documented complications attributable to the mesh device.

Medical records establishing the connection between the mesh implant and subsequent injuries form the foundation of viable legal claims.

Gathering the following evidence can help substantiate your legal claim:

• Documented complications requiring additional medical treatment or surgical intervention strengthen eligibility for compensation.
• Medical records must establish a connection between the mesh device and the injuries sustained.
• Claims must be filed within the applicable statute of limitations, which varies by state and typically ranges from one to six years.
• Identification of the specific mesh product used during surgery helps determine which manufacturer may be held liable.

Consulting with an experienced attorney can help determine whether individual circumstances meet the criteria for pursuing legal action against mesh manufacturers.

Damages Available in Breast Mesh Cases

Plaintiffs in breast mesh lawsuits may seek compensation for various types of harm resulting from defective devices or inadequate warnings.

The amount of potential recovery depends on the severity of injuries and their impact on the individual’s life.

Compensation in breast mesh lawsuits may include these categories of damages:

• Medical expenses including hospital bills, revision surgery, medications, and ongoing treatment costs may be recoverable.
• Lost wages and diminished earning capacity resulting from time away from work or permanent disability can be included in claims.
• Pain and suffering compensation addresses the physical discomfort and distress caused by mesh complications.
• Emotional distress damages recognize the psychological impact of disfigurement, multiple surgeries, and ongoing health concerns.
• Scarring or disfigurement resulting from mesh erosion, revision surgery, or implant removal may warrant additional compensation.
• Loss of quality of life addresses how complications have affected daily activities, relationships, and overall well-being.
• Inability to achieve natural looking results adds to the documented injury severity warranting compensation.

Individual compensation amounts vary based on the specific facts of each case, the severity of documented injuries, and the strength of evidence connecting harm to the mesh device.

If you believe you qualify for a breast mesh lawsuit, taking action promptly helps preserve your legal rights and ensures claims are filed within applicable deadlines.

Contact TruLaw using the chat on this page to receive an instant case evaluation that can help you determine if you qualify to file a Breast Mesh lawsuit today.

Our Breast Mesh attorney at TruLaw is dedicated to supporting clients through the process of filing a Breast Mesh lawsuit.

With extensive experience in product liability cases, Jessica Paluch-Hoerman and our partner law firms work with litigation leaders and medical qualified experts to prove how defective breast mesh implants caused you harm.

TruLaw focuses on securing compensation for medical expenses, revision surgery, pain and suffering, lost income, and other damages resulting from your breast mesh injuries.

We understand the physical and emotional toll that Breast Mesh complications have on your life and provide the personalized guidance you need when seeking justice.

Meet the Lead Breast Mesh Attorney at TruLaw

Meet our lead Breast Mesh attorney:

• Jessica Paluch-Hoerman: As founder and managing attorney of TruLaw, Jessica brings her experience in product liability and personal injury to her client-centered approach by prioritizing open communication and personalized attention with her clients. Through TruLaw and partner law firms, Jessica has helped collect over $3 billion on behalf of injured individuals across all 50 states through verdicts and negotiated settlements.

How much does hiring a Breast Mesh lawyer from TruLaw cost?

At TruLaw, we believe financial concerns should never stand in the way of justice.

That’s why we operate on a contingency fee basis – with this approach, you only pay legal fees after you’ve been awarded compensation for your injuries.

If you or a loved one experienced chronic pain, infection, mesh migration, capsular contracture, implant failure, or other complications from breast mesh implants, you may be eligible to seek compensation.

Contact TruLaw using the chat on this page to receive an instant case evaluation and determine whether you qualify to join others in filing a Breast Mesh lawsuit today.

Breast mesh lawsuits are being filed by women across the country who suffered serious complications from surgical mesh used in breast reconstruction and augmentation procedures.

TruLaw is currently accepting clients for the Breast Mesh lawsuit.

A few reasons to choose TruLaw for your Breast Mesh lawsuit include:

• If We Don’t Win, You Don’t Pay: The Breast Mesh lawyers at TruLaw and our partner firms operate on a contingency fee basis, meaning we only get paid if you win.
• Expertise: We have decades of experience handling product liability cases similar to the Breast Mesh lawsuit.
• Successful Track Record: TruLaw and our partner law firms have helped our clients recover billions of dollars in compensation through verdicts and negotiated settlements.

If you or a loved one suffered mesh migration, chronic pain, infection, or other complications after receiving breast mesh implants, you may be eligible to seek compensation.

Contact TruLaw using the chat on this page to receive an instant case evaluation that can determine if you qualify for the Breast Mesh lawsuit today.