You Weren’t Supposed to Get A Life-Threatening Infection After Breast Surgery

Even Worse: What If It Could Have Been Prevented?

Contact Us to Learn Your Legal Options.

If you suffered from a life-threatening infection after a breast lift, breast revision or another type of breast surgery, you may be able to take action that can help protect others.

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# Seri Surgical Scaffold Mesh Lawsuit

We’ve Been Warned About Seri Surgical Scaffold Mesh Before.

The scary part is that this isn’t really new – it’s just that no one really listened. In 2015, the FDA issued a warning to Allergen, the manufacturer of the Seri Surgical Scaffold, stating that Allergen was marketing the mesh for unapproved uses.

Now, women are suffering life-threatening infections such as “red breast” and other serious health problems after being implanted with Seri Surgical Scaffold. All because Allergen allegedly started marketing the product for unauthorized uses to help push the corporate bottom line.

The Seri Scaffold mesh can also be known as:

  • Silk mesh or bio-engineered silk mesh
  • A silk internal bra
  • A hammock or internal hammock
  • A sling
  • A silk screen

Contact us today to join other women coming together to tell the manufacturer that this was not okay. Women’s health matters more than corporate dollars.

What Do You Mean – I May Have Something in Me That Isn’t Supposed to Be There?

Yep. It’s unsettling, isn’t it? The Seri Surgical Scaffold was originally developed for use in plastic surgery to help the body recover. The idea was that the mesh would be made of silk so it would dissolve naturally in the body and never cause any harm to anyone. In fact, women may have been told that the product would dissolve within two years and their body would naturally create tissue to replace it. All natural. All safe. Totally easy, “miracle” solution.

At least, that seemed to be the idea on paper. In reality, the Scaffold was created from a bio-engineered silk, meaning that the mesh was artificially created and didn’t dissolve in the body like natural silk. On top of that, after receiving FDA approval, Allergen allegedly began marketing the Scaffold for procedures outside of the scope of that approval, as noted in the FDA warning letter.

The Scaffold was marketed for use in:

  • Breast revision surgery
  • Breast lift or Mastopexy
  • Breast reductions
  • Muscle flap reinforcement

And now women are getting infections so serious they had to go back to the hospital for “red breast” or other serious (as in, life-threatening/hospital-worthy) health problems.

FYI – In March 2016, a second letter from the FDA to Allergen showed that the company made changes necessary to address the violations in the 2015 warning letter.

Learn More

This Is About More Than Vanity. It’s About Women’s Health.

Women get various breast surgeries for different reasons, whether due to recovering from breast cancer, individual health reasons (ex: back problems due to breast size), or social pressure/expectations to look a certain way.

It does not matter why a woman underwent a breast surgery.

What matters is that a manufacturer is being accused of promoting a product for unauthorized, off-label use without informing women. (In fact, some surgeons even promoted the product as a “miracle” solution, but that’s a whole other issue.) And as a result, women were not able to make informed decisions about their health and are suffering from extremely serious health problems that could have been avoided.

And that’s never okay. Contact us to learn how you can help send a message that it is not acceptable to compromise women’s health and help protect other women from being hurt by Seri Surgical Scaffold.

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“Our office requests that Allergan immediately cease activities that result in the misbranding or adulteration of the SERI Surgical Scaffold…”

-FDA Warning Letter to Allergen, 2015