GalaFLEX Mesh Problems May Lead Women To Require Breast Implant Removal Surgery

As the first GalaFLEX lawsuits continue to be filed in Rhode Island state court, regulators are still receiving reports of breast mesh complications that often result in removal of the breast implant.

A growing number of women nationwide are reporting painful and debilitating GalaFLEX mesh complications, often resulting in the need for breast implant revision or removal surgery, after the surgical mesh product was used off-label during breast augmentation, breast lift or reconstruction surgery.

GalaFLEX Mesh is a resorbable synthetic surgical mesh made from poly-4-hydroxybutyrate, or P4HB, which was cleared by the FDA in May 2014 through the controversial 510(k) approval process. The device was cleared as a surgical film for soft-tissue support, including repair, elevation and reinforcement where weakness or voids exist, but it is now widely used off-label during breast augmentation or reconstruction.

Although it was never approved for use in the breast, critics claim that manufacturers have sold synthetic mesh products directly to cosmetic and reconstructive surgeons, knowing they would be used as an “internal bra” to support breast implants, reinforce breast tissue and help preserve shape after breast procedures.

Women now claim they were never adequately warned about the risk of breast mesh problems, including design defects that could cause the mesh to fail inside the breast, become painful, shift out of position, promote infections or lead to the need for breast implant removal surgery.

Over the last several years, adverse event reports submitted to the FDA’s MAUDE database have described GalaFLEX complications involving mesh rolling beneath the skin, failure to incorporate into tissue, infection, seroma, hematoma, wound breakdown, implant displacement, bottoming out, chronic pain and breast deformity.

In some reports, these breast mesh side effects allegedly led to explant surgery, implant removal or revision procedures to remove the failed mesh and repair the breast pocket.

As a result, GalaFLEX breast mesh lawsuits are now being filed for women who required additional surgery after receiving synthetic mesh during breast augmentation, breast lift, implant revision or reconstruction procedures. Plaintiffs allege that manufacturers failed to adequately test the products for breast surgery, failed to warn about the risk of mesh failure and continued selling the devices for a use that was never cleared or approved by the FDA.

GalaFLEX Complications Lead to Explant Surgery

GalaFLEX breast mesh does not usually need to be removed simply because a woman is unhappy with the cosmetic outcome. Explant surgery is more likely to become necessary when the mesh is tied to a medical complication, fails to provide the intended support, becomes painful or palpable, or interferes with proper healing of the breast pocket.

FDA MAUDE reports often describe a similar course of events. GalaFLEX is placed during breast augmentation, mastopexy, revision surgery or reconstruction. Weeks, months or even years later, the patient develops problems such as pain, swelling, infection, fluid buildup, wound breakdown, implant displacement or a loss of breast support.

When antibiotics, drainage, observation or other conservative treatment measures fail to resolve the problem, surgeons may need to reopen the breast pocket. In some cases, this involves removing the GalaFLEX mesh, removing or replacing the implant, draining fluid or blood, debriding damaged tissue and attempting to reconstruct the breast pocket.

Complications that may lead to GalaFLEX removal surgery include:

• Nerve damage or chronic pain, especially when mesh becomes palpable, folds, rolls, tightens the breast pocket or irritates nearby tissue.
• Delayed infection or abscess, particularly when infection develops more than 90 days after implantation and involves the mesh or implant pocket.
• Seroma, when fluid builds up around the mesh or implant and cannot be resolved with observation or drainage.
• Hematoma, when blood collects inside the breast pocket and requires drainage, evacuation or additional surgery.
• Mesh migration or displacement, including reports of mesh shifting, folding, rolling, detaching or failing to hold the implant pocket.
• Skin necrosis or tissue breakdown, when skin or breast tissue is damaged, breaks down, becomes infected or fails to heal.
• Reconstructive failure, when the mesh fails to provide lasting support, the implant drops, the breast becomes distorted or the pocket breaks down.
• Implant rupture or implant failure, when the implant is damaged, displaced or no longer supported by the mesh-reinforced pocket.

Real-World GalaFLEX Problems Involving Explant or Revision Surgery

While the FDA MAUDE reports do not prove that GalaFLEX caused the reported injuries, they provide real-world examples of the types of complications women have reported after GalaFLEX was used in breast augmentation, lift, revision or reconstruction procedures.

Together, the reports show why GalaFLEX lawsuits are focused on women who required explant or revision surgery. The concern is that women allegedly suffered complications serious enough to require another operation to remove failed mesh, treat infection, drain fluid or blood, repair damaged tissue, remove or replace the implant, or correct a failed reconstruction.

GalaFLEX Failure to Warn Lawsuits Being Filed

GalaFLEX breast mesh lawsuits are being pursued by women who allege they were never adequately warned about the risks associated with using synthetic mesh in breast augmentation, breast lift, implant revision or reconstruction procedures.

The claims allege that GalaFLEX was promoted and sold for breast surgery without FDA approval or clearance for that specific use. Plaintiffs contend that the product was presented to surgeons and patients as a safe, reliable internal support scaffold, while the manufacturers knew or should have known that the mesh could fail to perform as expected and cause serious complications.

According to recently filed GalaFLEX lawsuits, the mesh may fail to dissolve or incorporate properly into the surrounding tissue, triggering inflammation, chronic pain, infection, seroma formation, tissue damage, implant displacement, loss of breast support and the need for additional surgery. In many cases, women allege they only learned about these risks after suffering complications that required revision surgery, implant removal or GalaFLEX explant surgery.

The failure to warn allegations focus on whether manufacturers provided adequate risk information to doctors and patients before the mesh was implanted. Lawsuits also claim that stronger warnings should have been issued after manufacturers received reports of GalaFLEX complications, mesh failures, infections, painful scarring, failed reconstructions and other adverse outcomes following breast surgery.

Breast Mesh Explant Surgery Lawyers

As more women report GalaFLEX problems requiring additional medical treatment, breast mesh lawyers are investigating whether manufacturers withheld or minimized important safety information that may have changed the decision to use the product.

Financial compensation through a breast mesh lawsuit settlement may be available for women who received an internal bra mesh implant during breast reconstruction, augmentation, or revision surgery and later suffered any of the following;

• Nerve damage
• Infection or abscess
• Seroma
• Hematoma
• Migration or displacement
• Skin necrosis
• Reconstructive failure
• Implant rupture
• Explant or revision surgery

Submit information about your breast mesh complications for review by an attorney to determine whether you may be eligible to file a claim. All consultations are free, and cases are handled on a contingency fee basis, meaning there are no fees or expenses unless a settlement is obtained in your case.