FDA to Recommend Breast Implant Warning for Some Types of Implants

The U.S. Food and Drug Administration is recommending that manufacturers begin placing a breast implant warning on all saline and silicone gel-filled implants. The agency is preliminarily  recommending that those companies outline risks reportedly associated with the devices, including certain forms of cancer and other complications.

If you or your loved one suffered serious complications related to saline and silicone gel-filled breast implants, you may be able to file a lawsuit and recover damages with the help of a defective medical device lawyer.

For more information, contact Attorney Group. We offer free, confidential, no obligation consultations. We can help answer your questions, and if you choose to pursue a case we can connect you with an affiliated lawyer who can assist you throughout the legal process.

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FDA: Labeling Materials Would Improve Communication with Patients

In late October 2019, the FDA issued the non-binding draft guidance to “help ensure that a patient receives and understands the benefits and risks” related to saline and silicone gel-filled breast implants. According to the FDA, there is some concern that patients are not receiving or understanding such risks. Patients and health care providers are able to submit comments by December 23, 2019.

Breast implants are primarily used to increase breast size or to replace breast tissue in reconstructive surgical procedures. There are a number of risks associated with breast implants, and in some cases, revision surgery (or even multiple surgeries) may be needed to alleviate serious complications.

Common complications and adverse effects of breast implants may include:

  • Implant complications
  • Capsular contracture
  • Rupture and deflation
  • Breast implant associated-anaplastic large cell lymphoma (BIA-ALCL)
  • Connective tissue disease, breast cancer and reproductive problems

Additional symptoms may include fatigue, memory loss, rash, “brain fog” and joint pain. Women who have breast implants may or may not be able to breastfeed. Likewise, it is not known how breast implants might affect breastfeeding or babies born to women with implants.

How Can an Attorney Help?

Medical device makers have a duty to provide safe products. If there are risks of harm associated with breast implants and similar devices, they also must provide adequate warnings. If a device maker fails to fulfill this duty, it could be held liable in lawsuits for injuries that may result.

People injured by saline or silicone gel-filled breast implants may be eligible to recover money for:

  • Medical Expenses
  • Lost Wages
  • Pain and Suffering

The families of those killed may be eligible to recover money for funeral expenses and the pain that comes with losing a loved one.

The Time You Have to Pursue a Claim is Limited. Contact Us Today.

For more information, contact Attorney Group. After you contact us, an attorney will follow up to answer questions that you might have.

There is no cost or obligation to speak with us, and any information you provide will be kept confidential.

Please note that the law limits the time you have to pursue a claim or file a lawsuit for an injury. If you think you have a case, you should not delay taking action.