If you have had complications from a drug or device like GranuFlo, Naturalyte, Dialysis medications, the vaginal mesh, bladder sling, Mirena IUD, metal on metal hip replacement, Stryker Rejuvinate, Stryker metal rods hip replacement, Infuse bone graft, or any drug or medical device you can file an adverse incident report with the FDA. These are iimportant to do as the more there are the more chance warnings will be issued and even recalls. In the case of the vaginal mesh this is extremely important.
What you can do to make awareness of adverse events or side effects from a vaginal mesh or Mirena IUD or any drug or device?
You must stand up for justice and help others.The testing that helps to establish the safety of products, such as drugs and medical devices, is typically conducted on small groups before FDA approves the products for sale. Some problems can remain unknown, only to be discovered when a product is used by a large number of people. When you file an adverse incident report it helps get a dangerous product alert and /or recall established by the FDA. The more that file, the better chance of getting these off the market so they do not hurt anyone else. Once there is a warning or recall a lawsuit is usually filed and a multi distrct litigation established. This can even be done without a recall or warning. The more adverse incident reports the better it is for all injured people.
When problems with FDA-regulated products occur, the agency wants to know about them and has several ways for the public to make reports. Timely reporting by consumers, health professionals, and FDA-regulated companies allows the agency to take prompt action. The agency evaluates each report to determine how serious the problem is, and, if necessary, may request additional information from the person who filed the report before taking action.
What you need to make your report
You need to get your medical devices details. You can go to the hospital where mesh was implanted for these details or you can find your medical device details in your medical records by asking your surgeon’s secretary, you can apply for your medical records directly from the surgeon:
The details you require on your medical device are as follows:
The name of the medical device
The name of the manufacturer
The modal and serial number
If your surgeons secretary asks why you want these details please say you want to put in your adverse report into the FDA as there are already significant numbers on their database plus they have launched an investigation.
In the UK contact the MHRA
Online MHRA reporting adverse incidents involving medical devices:- www.mhra.gov.uk/Safetyinformation/Reportingsafetyproblems/Devices/index.htm
Note: You can ask the MHRA for the final manufacturer conclusion report on your medical device report. Stand up and get justice. File your adverse incident report and protect the public from a dangerous drug or devise and a manufacturer who did not do do diligence in warning the public.