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transvaginal mesh lawyer southfield

FDA Offers Recommendations for Transvaginal Mesh Surgery Patients

By Lipton Law on May 3, 2012 - No comments

Transvaginal Mesh Patient Safety MichiganTransvaginal mesh implants are flexible metal, plastic polymer, or biologic implants placed in the lower abdomen to treat a number of conditions, including pelvic organ prolapse (POP) and stress urinary incontinence (SUI). In 2008 and 2011, the U.S. Food and Drug Administration (FDA) issued warnings and recommendations to both health care providers and patients regarding the use of transvaginal mesh implants, which can cause serious health problems in some patients.

For patients with mesh implants or individuals considering surgery that includes them, the FDA offers the following recommendations:

  • If you’re preparing for surgery, talk to your doctor about non-mesh-implant alternatives, as well as non-surgical alternatives for treatment.
  • Ask what the possible side effects or complications of transvaginal mesh implants are, so that you know what to look for if you have problems after surgery.
  • Ask for a copy of the medical information and label that come with the transvaginal mesh implant. These contain more information about the particular implant you will receive or have received, including details on possible side effects.
  • Keep all your follow-up appointments with your physician. If you start having pain, bleeding, urinary incontinence, or other troublesome symptoms, or if your original symptoms return, see your doctor immediately.

Transvaginal mesh surgery complications can result in disabling side effects that can seriously impair your quality of life. If you’re suffering side effects from a transvaginal mesh implant, the experienced Michigan transvaginal mesh injury attorneys at Lipton Law can help. Call us today at (248) 557-1688 for a free and confidential case evaluation.

 

Many Transvaginal Mesh Devices Never Tested By FDA

By Lipton Law on April 4, 2012 - No comments

FDA Testing MichiganMost patients assume that, when they need a medical device implanted, that device has undergone extensive testing by the U.S. Food and Drug Administration (FDA) before it was allowed to be sold or placed inside patients. However, many devices aren’t scrutinized this closely, according to Consumer Reports.

Rather, many medical devices – including the transvaginal mesh implants currently being recalled nationwide – reach the market through what is known as the FDA’s “clearance” process. The clearance process can be used for any device that is substantially similar to a device that has already gone through the full, intensive FDA approval process. While not all devices can use the clearance process, those that can may make it to market simply because the manufacturer paid the necessary fees and submitted paperwork showing their device was “substantially similar” to one already on the market, not because the actual device has been examined closely.

However, “substantially similar” does not mean “identical.” Many of the transvaginal mesh implants currently causing serious problems for patients reached the market by the quicker clearance method, not by the more intensive study and approval process. Often, problems in these devices aren’t identified until actual patients suffer harm.

At Lipton Law, our dedicated Michigan transvaginal mesh implant injury attorneys care about helping injured patients seek justice in the way best suited to their individual lives. If you’ve been injured by a medical device or implant, call us today. Our number is (248) 557-1688, and your initial consultation is free and totally confidential.