(248) 557-1688

michigan transvaginal mesh lawsuit

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.

 

Lipton Law Product Liability Attorneys Help Michigan Victims of Transvaginal Mesh Failure through Mass Tort Action

By Lipton Law on March 7, 2012 - No comments

Transvaginal mesh is a medical device made from absorbable biologic material or absorbable or non-absorbable synthetic material which is surgically implanted through an incision in the vagina to repair and/or strengthen damaged or weakened tissue in a woman’s pelvic region. It is most often used to treat stress urinary continence (SUI) and pelvic organ proplapse (POP), and many women, in Michigan and across the nation, have undergone the procedure to accomplish just that. Unfortunately, it not only eventually failed in the repair of those conditions, but also caused numerous other complications that have jeopardized the physical and emotional health of thousands of women.

At Lipton Law, our dedicated product liability attorneys in Southfield are involved in a multi-district litigation effort on behalf of the innocent women in Michigan who have suffered due to the negligence of medical device manufacturers, Boston Scientific Corp., American Medical Systems, Inc., and Ethicon, Inc. /Johnson & Johnson. We are committed to helping the victims of defective transvaginal mesh obtain the compensation they deserve for the losses they’ve suffered.

The victims of defective transvaginal mesh have experienced a variety of adverse complications as the result of medical device failure, leading to additional medical costs, time lost from work, pain and suffering, and emotional distress. According to the U.S. Food and Drug Administration (FDA), over 1,000 reports were received between 2005 and 2007 concerning adverse effects from the transvaginal mesh. Some of these included:

  • Erosion through vaginal epithelium;
  • Pain;
  • Urinary problems;
  • Recurrence of organ prolapsed or incontinence;
  • Infection;
  • Internal bleeding; and
  • Dyspareunia (pain during sexual intercourse).

Treating these side effects typically involves surgery, IV therapy, and/or draining of abscesses or hematomas.
It is a product manufacturer’s responsibility to ensure that their product, especially if it is a medical device, not only does what it is intended to do, but also does not cause any serious side effects. Insufficient safety testing only leads to disaster. If you have suffered injury or illness after a transvaginal mesh procedure, the compassionate Michigan transvaginal mesh mass tort attorneys at Lipton Law can help you hold the at-fault parties liable for the physical, financial, and emotional hardships they have caused you. Please contact us today with any questions or concerns you may have. Call us for a free consultation today at (248) 557-1688 or (800) 322-1688.