Yesterday, a jury returned to a New Jersey courtroom and returned their verdict of $3,350,000 against Johnson & Johnson, and for a South Dakota plaintiff named Linda Gross, in the first of almost 2000 vaginal mesh product injury cases filed by women all across the country suffering from conditions like pelvic organ collapse against Johnson & Johnson and its subsidiary company, Ethicon. Ms. Gross has had to endure 18 surgeries to try and fix what has happened to her because of this defective product.
There are also other vaginal mesh cases that are on file, against other manufacturers of vaginal mesh products, that may be impacted by the decision of this one jury of twelve people this week. Additionally, the New Jersey case isn’t over: this morning, a hearing began on how much money will be assessed against Johnson & Johnson and Ethicon in punitive damages.
Johnson & Johnson is facing allegations that its promotional materials for its vaginal mesh product, an implant placed into the body, did not give her doctor enough information about the risks and dangers of this product and as a result, these plaintiffs have suffered serious harm. And this is something that Johnson & Johnson has deem a serious enough danger to its own bottom line that it has notified its stockholders of these pending lawsuits in its latest Annual Report to its shareholders.
In its Annual Report, filed February 22, 2013, Johnson & Johnson reports that 42 state attorneys general, led by the California Attorney General, are investigating allegations into its vaginal mesh implants as well as its surgical mesh and right now, the company and its subsidiaries have agreed in writing with these states to toll the statute of limitations (or filing deadline) on the state’s potential lawsuits while these investigation continue.
What is Pelvic Organ Prolapse and Who Needs Vaginal Mesh Surgery?
Women suffer from pelvic organ prolapse, or POP, when one of their internal organs – most often, the bladder – to fall or prolapse from its natural position because abdominal muscles have stretched and have been weakened due to things like giving birth. Sometimes, more than one organ is involved, or falls.
Women experiencing POP will have a variety of symptoms and there are treatment options to be tried before surgery is considered. Symptoms include:
- Feeling pressure from pelvic organs pressing against the sides of your vagina.
- Feeling very full in your lower belly.
- Feeling as if something is falling out of your vagina or feeling something in your vagina when you wipe after using the bathroom.
- Feeling a pull or stretch in your groin area or pain in your lower back.
- Releasing urine without meaning to (incontinence), or needing to urinate a lot.
- Having pain during sex.
- Having problems with your bladder or bowels, such as constipation or problems emptying your bladder.
FDA Information for Those Who Have or Are Considering Vaginal Mesh Surgery ( Pelvic Organ Prolapse or POP Surgery)
The FDA has been monitoring these vaginal mesh products and on its website, the following information is provided to women suffering from pelvic organ prolapse or needing transvaginal repair. Here, from the Food and Drug Administration website:
Women who have mesh surgery may be at risk for needing additional surgery due to mesh-related complications. In a small number of patients, repeat surgery may not resolve complications. Ask your surgeon about all POP treatment options, including surgical repair with or without mesh and non-surgical options, and understand why your surgeon may be recommending treatment of POP with mesh.
If you are considering surgery with the use of surgical mesh to repair your POP, ask your surgeon these questions BEFORE you agree to the procedure:
- Are you planning to use mesh in my surgery?
- Why do you think I am a good candidate for surgical mesh?
- Why is surgical mesh being chosen for my repair?
- What are the alternatives to transvaginal surgical mesh repair for POP, including non-surgical options?
- What are the pros and cons of using surgical mesh in my particular case? How likely is it that my repair could be successfully performed without using surgical mesh?
- Will my partner be able to feel the surgical mesh during sexual intercourse? What if the surgical mesh erodes through my vaginal wall?
- If surgical mesh is to be used, how often have you implanted this particular product? What results have your other patients had with this product?
- What can I expect to feel after surgery and for how long?
- Which specific side effects should I report to you after the surgery?
- If I develop a complication, will you treat it or will I be referred to a specialist experienced with surgical mesh complications?
- What if the mesh surgery doesn’t correct my problem?
- If I develop a complication, will you treat it or will I be referred to a specialist experienced with surgical mesh complications?
- If I have a complication related to the surgical mesh, how likely is it that the surgical mesh could be removed and what could be the consequences?
- If a surgical mesh is to be used, is there patient information that comes with the product, and can I have a copy?
If you have surgery with mesh to repair your POP, you should:
- Continue with your annual and other routine check-ups and follow-up care. There is no need to take additional action if you are satisfied with your surgery and are not having complications or symptoms.
- Notify your health care provider if you have complications or symptoms, including persistent vaginal bleeding or discharge, pelvic or groin pain or pain with sex, that last after your follow-up appointment.
- Let your health care provider know you have surgical mesh, especially if you plan to have another surgery or other medical procedures.
- Talk to your health care provider about any questions you may have.
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Health care providers cannot evaluate any potential legal claims for damages due to defective products and the harm they cause, like these vaginal mesh products. If you or a loved one suspect that you may have been harmed by a mesh product, then do not depend upon your doctor or nurse to assist you with investigation of legal claims; instead, seek out the counsel of an experienced plaintiffs attorney with experience in representing victims of defective products.
