Articles Posted in Defective Medical Implants

Too often people are intimidated by health care providers and follow their direction without asking important questions. They often fail to do what they can to protect themselves by asking those questions and not being afraid to do so or by going on the internet to research a drug prescribed or a surgical procedure recommended.

I always encourage people to ask questions, do research and even call me for advice BEFORE undergoing a surgical procedure or taking a particular drug. In my work as San Francisco injury lawyer, I have represented many patients who ultimately became harmed by drugs and procedures they did not know would hurt them. Sometimes they were never informed of the risks involved in taking the medication or having a particular surgical procedure or medical device implant.

Health care providers are required by law to obtain an informed consent whenever they recommend treatment. In California, our supreme court has established that a physician is required to disclose “all information relevant to a meaningful decisional process.” Cobbs v. Grant (1972) 8 Cal.3d 229, 242. That means doctors and other medical practitioners must tell patients what alternatives exist to recommended treatment, what risks are presented by the recommended treatment, and what to expect if they follow the medical advice being given them.

In our law practice, we have represented many clients who have suffered serious injury as a result of having been inadequately informed. At trial involving patient injuries, often the jury instructions we propose which are well-established in California have to do with informed consent, the failure to provide informed consent and related issues that a jury must decide.

When a doctor prescribes a drug, the patient needs to ask the following questions:

First, why are you prescribing this drug and are there other drugs that perform the same or similar functions?

Second, is this a new drug on the market? (Doctors are very susceptible to persuasion by drug reps that they should try new drugs which do not have a track record and can be dangerous);

Third, what are the side effects of the drug; are there any side effects that can cause death or serious injury?;

Fourth, what should I look for when taking the drug to determine whether or not I am suffering ill effects from the drug; what should I do if any changes occur after I begin to take the drug?

After these questions are answered, the patient should go on line and research the drug for side effects. The Food and Drug Administration has a website where one can access adverse event reports pertaining to drugs and medical devices which are on the market. That is also a good resource for information. Taking these steps might well avoid the types of serious injuries that our clients have suffered from drugs prescribed by their physicians.

If you have concerns after asking these questions and researching the drug itself, call your doctor and discuss these with him or her. Do not feel that you are being a “difficult” patient or are outside your rights to be very comfortable about your own health. Do not let your physician or medical staff cause you to believe that you do not have a right to know these things. You do. If you believe that your doctor is not willing to fully discuss and address your concerns, consider finding a physician that is more open and willing to go through this process with you.

The same issues and concerns for patients apply to recommended surgical procedures. Next post, I will share important information about informing yourself about surgical risks.
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Nearly a year ago, we posted on the dangers of transvaginal implantation of surgical mesh, including the risks and complications associated with procedures for Pelvic Organ Prolapse or POP and Stress Urinary Incontinence or SUI. After thousands of women have been implanted with the surgical mesh transvaginally, the federal government now says, beware.

Today, in a stunning development, the U.S. Food and Drug Administration issued an update to their prior safety communication that warns both health care providers and patients that the transvaginal surgical mesh procedure used to repair POP could well “expose patients to greater risk than other surgical options” with no evidence that patients’ quality of life will be improved by this procedure.

At the time we warned our readers about this last year, vaginal mesh manufacturers had already reported many complications to the FDA including infection, pain, vaginal epithelium erosion, urinary problems, and the return of conditions for which the procedure was performed. The FDA’s 2008 safety communication was due to adverse events occurring to patients after the transvaginal placement of mesh. The numbers have continued to rise since that time. In our view, the procedure is not worth the potential pain and suffering that patients may endure.