Gynecare Intergel Lawyers

Following reports that Gynecare Intergel Adhesion Prevention Solution caused injury to a number of women, attorneys are looking into the possibilities of suing Ethicon Inc. During gynecological surgery, the solution was used to shield tissue as it healed. Still, in certain instances, it seriously injured patients.

Gynecare Intergel Solution was first developed to help in the postoperative setting to prevent the formation of adhesions following pelvic surgery. In layman’s words, adhesion is the development of scar tissue that can lead to internal organ adhesion following surgery.

Most women who have had pelvic surgery experience adhesions, which can also be linked to sexually transmitted diseases, endometriosis, and pelvic inflammatory disease (PID).

Adhesions can hurt and have a specific physiological effect on a woman. For instance, adhesions are estimated to be the root of 74% of all intestinal blockages in women. They account for 15-20% of infertility cases, making them a major contributor.

Three fatalities were reported in connection with Gynecare, according to 103 complaints made to the US Food and Drug Administration (FDA). Other injuries included pelvic pain, internal scarring, infertility, allergic reactions, and tissue adhesion. Gynecare injuries in some women necessitated extra surgery to address the issues.

Gynecare Worldwide sent a letter to doctors on March 28, 2003, with the subject line “Urgent Voluntary Market Withdrawal of Gynecare Intergel Adhesion Prevention Solution.” In the letter, Gynecare urged physicians to stop using the medicine right away while it evaluated complaints of “onset of discomfort, non-infectious foreign body responses, and tissue adhesion.”

Lifecore Biomedical Inc. was named as a defendant in 80 product liability claims in which the plaintiffs alleged they sustained injuries as a result of the use of Gynecare Intergel during their surgeries, according to a filing with the Securities and Exchange Commission (SEC) of the United States.

Ethicon, Inc., Johnson & Johnson, and Vital Pharma, the contract packager for Intergel Solution, were all named as defendants in the lawsuits.

According to the filing, settlement agreements for 79 of the claims have been signed as of September 20, 2006. Even if those lawsuits were settled, other lawsuits might still be brought.

Gynecare Intergel was misbranded, and Lifecore failed to submit required Medical Device Reports (MDRs) for 11 complaints involving device malfunctions that resulted in serious injury or death, according to a letter Lifecore received from the FDA Center for Devices and Radiological Health (CDRH) in 2004.

“Specifically, for 11 separate events…you failed to submit an MDR to the Food and Drug Administration within 30 days of receiving information that reasonably suggested that one of your commercially distributed devices may have caused or contributed to a death or serious injury,” the FDA warned in its warning letter.

The letter continued by citing the instance of a patient who experienced significant abdominal pain along with tachycardia, a fever, and shortness of breath.

Gynecare Intergel received market approval in 1998 and was voluntarily discontinued in 2003. It was used off-label for laparoscopic surgery and hysterectomies but was FDA-approved for use in open gynecologic procedures.

Studies indicated that the use of the solution was connected with a higher infection rate; hence it was not approved for laparoscopic surgery. Laparoscopy and hysterectomy experiments did not demonstrate the safety or efficacy of Gynecare Intergel.

Surgical procedures used Gynecare Intergel to avoid adhesions. Most women who undergo abdominal surgery, particularly those for treating endometriosis and the excision of fibroid tumors, develop adhesions, which can impair fertility and clog the intestine.

Gynecare is a division of Johnson & Johnson. Lifecore Biomedical Inc. makes Intergel Solution.

Some Gynecare Intergel History

The Food and Drug Administration initially declined to approve the product, reasoning that the gel actually increased a woman’s risk of infections. The FDA eventually approved Intergel as an anti-adhesion surgical gel for gynecological procedures in November 2001.

The FDA reconsidered its judgment when the maker filed an appeal. The appeal commission overturned the first FDA denial and cleared the glue, but only as “reasonably safe.” The FDA reports that compared to 2.9% of women who had more conventional care, 5.6% of those who received the gel experienced an infection at the surgery site.

Gynecare Intergel Adhesion Prevention Solution’s producer is now evaluating technological problems, surgical approaches, and circumstances related to these post-market incidents.

Consult your doctor if Intergel has caused any health issues for you. You could also wish to get in touch with a lawyer who can assist in defending your legal rights. Please be aware that there might be a statute of limitations and take action immediately.

A “Dangerous Precedent” at the FDA: The Intergel Scandal

Many opponents are asking why the Food and Drug Administration approved Intergel for medical use in the wake of the Gynecare Intergel recall. Could it be, as some claim, that the FDA is engaging in political games with the pharma companies that support it?

Initial Intergel Response: “Not Approvable”

The FDA first deemed Intergel “not approvable” in 2000 after concluding that using it increased women’s chances of infection. Lifecore, the product’s maker, appealed the decision. In November 2001, the FDA approved the product.

The FDA only deemed the usage of Intergel to be “reasonably safe” even after it was approved. According to a study of 281 women cited by the FDA, 5.6% of Intergel recipients experienced an infection at the surgical site, compared to just 2.9% of women who underwent normal surgical care.

Given these facts, why or how did the FDA approve Intergel?

FDA Releases Fatal Findings

More than 70 “adverse events” with Intergel have been reported to the FDA, including three fatalities and 48 injuries. One “adverse event report” submitted to the FDA said a patient passed away after using Intergel during a laparoscopic hysterectomy.

As stated in the report:

“…the patient had discomfort and other symptoms a few days later. The bowel was damaged. Sepsis symptoms were present; thus, the patient was brought into surgery, where an exploratory laparotomy was done. Two days later, the patient passed away. The physician thought Gynecare Intergel was at fault.”

The FDA didn’t send Lifecore a warning letter until early January 2003, and on March 27, 2003, the business voluntarily recalled Intergel.

An Unsafe Precedent?

We may never fully understand the details that led the FDA to change course and approve Intergel in 2001. However, others contend that the FDA’s funding structure makes it susceptible to conflicts of interest. Public dollars long supported the FDA, but now it receives a portion of its funding from the pharmaceutical and medical industries it regulates.

“More than half of the budget of the section of the FDA that approves new pharmaceuticals and regulates drug safety is being paid by the drug companies,” says Dr. John Abramson of Harvard Medical School.

Consumer advocacy organization Public Citizen claims that this circumstance has “produced an intolerable conflict of interest whereby the FDA is figuratively enslaved to the sector it is meant to be regulating. The FDA’s safety standards have decreased as a result.”

Should I Speak with an Attorney?

You should visit your doctor immediately if you or a loved one has been hurt while using the Gynecare Intergel Solution. If you have been hurt, you should speak with a class action lawyer who can assist you in obtaining compensation for your harm.