FDA Vaginal Mesh Warning

Persistent Personal Injury Attorneys Provide Breaking News from the FDA about Transvaginal Mesh Complications

Presenting up-to-the-minute news regarding the FDA and transvaginal mesh

Since 1976 the FDA has allowed companies who have created newer versions of existing products to by-pass the standard requirement for testing under the 510(k) provision. So when doctors started using mesh patches for hernia surgeries, they indirectly left the door open for manufacturers to take advantage of the FDA loophole in the creation of pelvic mesh. No clinical testing was done on TVM before it came on the market.

The attorneys of the Phillips Law Offices in Chicago don’t believe that you should have to pay with your health for the mistakes of greedy manufacturers. We work diligently with you to get you the compensation you need and deserve.

FDA transvaginal mesh complications warnings went unheeded

The FDA issued its first warning about vaginal mesh surgery in October of 2008, and then released another in 2011. The warnings stated that:

  • Using TVM for Pelvic Organ Prolapse (POP) was a continuing serious concern
  • Serious complications associated with TVM “are not rare”
  • Mesh used for POP repairs brings with it certain additional risks
  • Having vaginal mesh surgery isn’t a better option, as there is no evidentiary support of this idea

As of January 2012, the FDA mandated that all TVM manufacturers conduct studies on the safety of their products and report those findings back to the FDA.

What the FDA says to do

The FDA offers recommendations for patients who are undergoing or who have undergone a medical procedure to repair POP:

  • Question the surgeon. Ask your surgeon if he/she is planning on using mesh, and if there are alternatives that can be used instead.
  • Keep an eye open. Once your surgery is over, monitor your body and any potential symptoms carefully.
  • Contact the FDA. If you experience any pelvic mesh complications, send pertinent information to the FDA.

The FDA may be keeping careful records of the victims of TVM complications, but we’re using those records to help. Our dedicated counselors fight for you in court if necessary to get you the settlement you deserve

Call our firm for information about FDA recalls

Contact Phillips Law Offices in Chicago for the latest information about TVM implants and FDA regulations that apply to your case. One of our qualified attorneys can walk you through the process of filing a claim against a manufacturer. Reach us online or at [ln::phone] for a free consultation with an experienced products liability lawyer.