Internal Bra Side Effects Raise Questions About Manufacturers’ Knowledge of Mesh Failures

Investigations are now raising questions about how much manufacturers knew about the potential side effects of internal bra mesh scaffolds, which have been commonly used in breast augmentation and reconstruction surgeries.

After years of lawsuits over side effects caused by hernia mesh and transvaginal mesh implants, many of the same manufacturers are now under investigation for selling similar mesh products that are being used in breast lift and augmentation surgeries, despite the devices never receiving FDA approval for cosmetic or reconstructive purposes.

Originally developed for hernia repair and other soft-tissue reinforcement procedures, breast mesh implants have been heavily used for off-label use in cosmetic and reconstructive breast surgery.

These “internal bra” devices are typically made from synthetic polymers, such as polypropylene, or from biologic materials known as acellular dermal matrices (ADMs), which are designed to integrate into surrounding tissue and gradually absorb over time.

However, critics claim that manufacturers have sold products like GalaFLEX, Phasix, Strattice and AlloDerm to plastic surgeons as part of a remarketing strategy that rebrands long-used, and potentially faulty, mesh materials as surgically innovative internal bras to support breast implants, reinforce tissue, and preserve shape after a breast lift or augmentation procedures.

Concerns About Side Effects of Internal Bra Breast Mesh

These challenges to the mesh use have been voiced by women who have undergone these procedures, now reporting a wide range of breast mesh complications, including chronic inflammation, nerve pain, infection and breast hardening, as well as capsular contracture, in which scar tissue tightens painfully around the implant.

In some cases, the mesh has been found to shrink, warp, or migrate beneath the skin, distorting the breast’s shape or causing visible rippling. Surgeons have also documented instances of tissue necrosis, seroma formation and mesh exposure, which can require multiple corrective surgeries or full removal of the implant material.

Many women who underwent breast lift or augmentation procedures involving surgical mesh now claim they were never told the devices lacked FDA approval, or that these similar mesh materials used in hernia and transvaginal mesh implants had previously been linked to serious complications.

As a result of the manufacturers’ failure to adequately disclose risks associated with their products, breast mesh lawsuits are now being investigated nationwide on behalf of women who suffered severe complications following breast lift or augmentation procedures.

In this featured post, AboutLawsuits.com examines the long history of problems tied to surgical mesh products, issues repeatedly revealed through major product liability litigations, which many experts say should have alerted manufacturers to the risks before selling these materials to surgeons for cosmetic breast lifts and augmentation procedures.

History of Implantable Mesh Lawsuits & Settlements

The growing controversy over internal bra mesh closely parallels the history of hernia mesh and transvaginal mesh, two products once hailed as medical breakthroughs but later linked to widespread injuries and lawsuits.

Hernia mesh was introduced to strengthen weakened abdominal tissue and reduce the chance of recurrence. The mesh, typically made from polypropylene, was designed to act as a permanent scaffold, reinforcing the abdominal wall as the body healed.

Similarly, transvaginal mesh was developed to treat pelvic organ prolapse (POP) and stress urinary incontinence (SUI), conditions caused by weakened pelvic floor muscles. Manufacturers promoted both as faster, less invasive alternatives to traditional surgical repairs.

Initially marketed as safe, long-term solutions that would integrate seamlessly with the body, these devices soon drew thousands of injury reports. Patients described chronic pain, infection, mesh erosion and internal organ damage, often requiring multiple revision surgeries or permanent removal of the implants.

As injuries mounted, tens of thousands of hernia mesh lawsuits and transvaginal mesh lawsuits were consolidated into large multidistrict litigations (MDLs), where discovery revealed internal company documents showing that manufacturers were aware of problems like mesh shrinkage, brittleness and inflammatory reactions years before the devices were recalled or redesigned.

The MDLs resulted in billions of dollars in settlements and verdicts across multiple manufacturers.

• American Medical Systems (AMS) agreed to pay approximately $830 million to resolve the majority of its vaginal mesh claims.
• A California jury awarded $5.5 million against C.R. Bard in one of the first vaginal mesh trials involving its Avaulta implant.
• Covidien settled more than 11,000 transvaginal mesh lawsuits, further underscoring the widespread scope of injuries.
• In the hernia mesh litigation, C.R. Bard reached a confidential global settlement resolving tens of thousands of claims, structured as a multi-year payout program.

Yet, many of the same companies behind those past products have reintroduced similar mesh materials under new branding, which are now being used in breast lift and augmentation surgeries.

Internal Bra Injury Patterns Mirror Earlier Mesh Failures

Reports of complications linked to internal bra mesh implants echo the same kinds of failures seen in earlier hernia mesh and transvaginal mesh cases.

While each device serves a different surgical purpose, the biological reaction is often identical — the body’s immune system attacking or rejecting foreign mesh materials that were never designed for long-term implantation.

🔹 Hernia Mesh Complications

Used to reinforce weakened abdominal walls, hernia mesh products have been tied to:

• Mesh migration and shrinkage, which can cause bowel obstructions or organ adhesion
• Chronic infections that result in long-term abdominal pain and inflammation
• Scar tissue fusion, where the mesh adheres to surrounding organs
• Complex revision surgeries to remove degraded or displaced mesh

🔹 Transvaginal Mesh Complications

Originally introduced to treat pelvic organ prolapse and incontinence, these devices often led to:

• Mesh erosion through the vaginal wall, causing bleeding, painful scarring and infection
• Nerve injury and sexual dysfunction due to mesh contraction or exposure
• Persistent inflammation and recurring infections even after mesh removal
• Multiple revision procedures that failed to restore normal tissue function

🔹 Breast Mesh (Internal Bra) Complications

Women who underwent breast lift or augmentation procedures with surgical mesh have reported:

• Capsular contracture, where scar tissue tightens painfully around the implant
• Mesh shrinkage, warping or migration, distorting the breast’s shape
• Tissue necrosis or open wounds from mesh exposure beneath the skin
• Chronic pain and inflammation requiring mesh removal or reconstructive surgery

Across all three products, the complication patterns are nearly identical. Mesh materials meant to strengthen and stabilize soft tissue often harden, degrade, or trigger inflammatory responses that result in chronic pain, tissue damage and disfigurement — sometimes years after implantation.

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Manufacturers Were Aware of Longstanding Mesh Risks

The controversy over internal bra mesh implants highlights how both regulatory loopholes and corporate decisions have left patients vulnerable to preventable harm.

⚖️ The 510(k) Clearance Loophole

Critics say many of the problems stem from the FDA’s 510(k) clearance process, which allows new medical devices to reach the market if they are deemed “substantially equivalent” to existing ones, without requiring new clinical trials or independent long-term safety studies.

This process has long been criticized for letting manufacturers bypass meaningful testing, especially when new products are derived from devices that already faced recalls, litigation or safety warnings.

In the case of breast mesh implants:

• Manufacturers obtained clearance by citing prior approvals for soft-tissue reinforcement or hernia repair, not breast surgery.
• No synthetic mesh has ever been formally cleared by the FDA for cosmetic breast lift or augmentation.
• Patients and even surgeons often mistakenly believe the devices are FDA-approved for breast use, when they are not.

This regulatory gray area, critics warn, allowed products with unproven safety records to be sold for elective cosmetic procedures — exposing women to the same risks that had already plagued hernia and transvaginal mesh recipients.

🧾 Manufacturers’ Knowledge of Known Complications

While the FDA regulates medical device clearance, the responsibility for ensuring product safety ultimately rests with manufacturers. Women who experienced complications from internal bra mesh implants now claim that these companies should have known about potential risks based on prior product data and litigation history.

Evidence from earlier mesh lawsuits revealed:

• Internal company documents detailing concerns about mesh shrinkage, brittleness and erosion
• Reports of chronic inflammation and tissue rejection in both hernia and transvaginal mesh products
• Manufacturer awareness of recurring complications long before any recalls or design changes were made

Many of the same materials, particularly polypropylene and biologic acellular dermal matrices (ADMs), are still used in the new generation of breast mesh implants. Critics argue that, given this history, manufacturers had a duty to conduct new safety testing before promoting these products for elective breast procedures.

However, by relying on the same 510(k) framework and previously approved materials, manufacturers were able to sell breast mesh without proving their long-term safety.

Internal Bra Lawsuits Over Breast Mesh Failures

As litigation into these issues continues, financial compensation may become available through a breast mesh lawsuit settlement for women who underwent breast reconstruction, augmentation or revision surgery that involved the use of a mesh implant and subsequently developed serious complications, including:

• Infection or abscess formation, including cases requiring antibiotics, hospitalization or surgical removal
• Chronic pain or nerve damage around the chest, breast or underarm area
• Seroma (persistent fluid buildup or swelling beneath the breast)
• Capsular contracture, in which scar tissue tightens painfully around the implant
• Mesh migration or displacement, leading to asymmetry, breast distortion or loss of implant support
• Implant rupture or reconstructive failure requiring removal or replacement
• Interference with breast imaging, including mammogram or ultrasound detection issues
• Permanent scarring or disfigurement following mesh removal
• Removal, replacement or revision surgery due to mesh-related complications or failure

Breast mesh lawyers are pursing claims to seek compensation for medical expenses, pain and suffering, lost income, and other financial losses caused by breast mesh complications.