What is Seprafilm
I just had a conversation with a woman whose surgeon used Seprafilm during her mesh removal surgery at a hospital in the U.S. She read it in her operative report and asked me about it because she has had huge problems since the surgery. Her stomach was opened up from side to side and this product was used in various stomach surgeries. So as usual I decided to research to find out what it is and I was quite shocked when I read the following. So ladies it is time to get out your operative report to find out what was used on you. If you have had MAJOR problems since your surgery, but did not know why, please look into it.
This is important to know even if you had laparoscopic or keyhole surgery, however, this woman had her stomach completely cut open for her mesh removal and it was used at that time.
Genzyme Corp. has agreed to pay $22.28 million to resolve allegations that it marketed, and caused false claims to be submitted to federal and state health care programs for use of, a “slurry” version of its Seprafilm adhesion barrier, the Justice Department announced today. Seprafilm is a thin film intended to reduce adhesions after surgery by forming a bio-resorbable barrier between abdominal tissue and organs. Genzyme is a biotechnology corporation based in Cambridge, Mass., and was acquired by Sanofi-Aventis SA in April 2011.
“There will be consequences when medical device companies alter products to increase sales and profits without regard for risks to patient safety,” said Assistant Attorney General for the Justice Department’s Civil Division Stuart F. Delery. “Federal health care participants should receive only devices that are medically reasonable and necessary.”
The government alleges that Genzyme sales representatives taught doctors and other staff to cut the Seprafilm sheets into small pieces, add saline and allow the pieces to dissolve until the desired consistency was reached. This mixture was referred to as “slurry.” Genzyme sales representatives traded recipes for slurry, and trained each other in how to create it. The slurry was used in laparoscopic or “key hole” surgeries by inserting a catheter filled with the mixture into the body and squirting it into the abdominal cavity. Seprafilm is FDA-approved for use in open abdominal surgery but not for minimally invasive surgeries, such as laparoscopic or key hole surgery. Allegedly, as a result of this conduct, Genzyme knowingly caused hospitals and other purchasers of Seprafilm to submit false and fraudulent claims to federal health care programs for uses of Seprafilm that were not reimbursable.
“Beneficiaries of federal health care plans, including Medicare recipients and military families, should not be treated with devices that have been improperly altered,” said Acting U.S. Attorney for the Middle District of Florida A. Lee Bentley III. “When companies promote such practices, resulting in the submission of health care claims that cannot legally be reimbursed, they will be made to pay by this office and the Department of Justice.”
“As with drugs, patients need assurance that medical devices are safe and effective,” said Inspector General of the U.S. Department of Health and Human Services Daniel R. Levinson. “The government contends that Genzyme marketed an altered, untested device. Taxpayers and patients deserve better.” You can read this on this link
I also looked it up and found this on the actual site for this product and yes there are lawsuits against the company about this product.
Adhesion Barrier (membrane) is a sterile, bioresorbable, translucent adhesion barrier composed of two anionic polysaccharides, sodium hyaluronate (HA) and carboxymethylcellulose (CMC). Together, these biopolymers have been chemically modified with the activating agent 1-(3-dimethylaminopropyl) -3- ethyl- carbodiimide hydrochloride (EDC). Seprafilm should be stored between 36-86°F (2-30°C) until the package expiration date.
Seprafilm Adhesion Barrier is indicated for use in patients undergoing abdominal or pelvic laparotomy as an adjunct intended to reduce the incidence, extent and severity of postoperative adhesions between the abdominal wall and the under-lying viscera such as omentum, small bowel, bladder, and stomach, and between the uterus and surrounding structures such as tubes and ovaries, large bowel, and bladder. This is that link
So what can you do if you find that Seprafilm was used? Well I found this on a lawyer’s site. The petition quotes a case report involving a 71 year-old woman who died from post-operative complications after being implanted with Seprafilm. According to the report, she had to have several surgeries to remove a “dense, thick, glue-like mass involving 95% of the small bowel and part of the transverse colon, anchoring the abdominal contents to the anterior abdominal wall.”
Seprafilm Side Effects
Public Citizen has reviewed the FDA database of adverse events and found at least 21 reports of death and 524 adverse events linked to Seprafilm between 1998-2015. Many of those reports involve life-threatening side effects.
Side effects linked to Seprafilm:
- Bowel obstruction
- Bacterial abscess
- Fluid collection in the abdomen
- Inflammatory reaction
- Poor healing after surgery
- And more
This is what this product looks like.