The FDA panel which conducted a hearing on Yaz birth control pill safety in December 2011 is now under fire. Panel members with ties to Bayer, the manufacturer of the pill in question, have been accused of a conflict of interest, which has branded the hearing as a sham.

The hearing was conducted to determine the safety of Yaz, Yasmin and Ocella and other birth control pills containing an ingredient called drospirinone. The hearing would determine whether a recall was warrented or if the packaging clearly notified consumers of the potential risks.

Complaints about drospirinone-containing oral contraceptives claimed women suffered from various side effects, including deep vein thrombosis, pulmonary embolisms, stroke and gall bladder damage. If left untreated, these side effects may result in death, which prompted the FDA’s hearing last December.

During a close vote of 15-11, the panel decided that the Yasmin and similar birth control products will stay on the market. However, former FDA commissioner, David Kessler, questioned the integrity of the panel when revealing documents shows that some members of the panel had ties to the manufacturers of the pill. Kessler also cited that the documents show that one member is a “huge advocate” of Yasmin and a “Bayer trained speaker.”

Panel members were reminded prior to the start of the hearing that voting memebers were subject to federal conflict of interest laws. Because of this, one voting member was not allowed to vote due to allegations of “intellectual conflict of interest.” Sidney Wolfe, M.D., head of the Public Citizen Health Group, is a vocal critic of the FDA and oral contraceptives, citing health risks.

Women who are currently involved in Yaz birth control lawsuits, want the Courts to examine this conflict of interest to determine whether the hearing was acting in the best interests of the consumer or the manufacturer.

Additional information about Yasmin or Yaz side effects can be found at LegalView.com.

After seeking a hearing on the safety of transvaginal mesh, House Democrats are now advancing their campaign for safe and effective medical devices by calling the overhauling of the Food and Drug Administration’s Pre-Market Notification (PMN) Clearance or simply 510(k) Approval System, and thus introducing HR 3847 – a legislation that will allow the FDA to block clearance of devices whose predicates were previously identified with safety issues.

Under Section 510 (k) of the Food, Drug and Cosmetic Act, clearance to medical devices can be granted even without human testing for as long as they are “substantially equivalent” to past devices previously cleared. These ‘past devices’ are called predicates.

Democratic legislators, led by Rep. Edward Markey, D-Mass, are zeroing in at current vaginal mesh products and other medical devices whose predicates were withdrawn from market due to safety issues and defects. Citing injuries from transvaginal implants produced by leading manufacturers, Democrats want the FDA to update the present 510(k) System so that devices with defective predicates are not allowed to be sold without the manufacturers proving first that the new devices do not suffer the defects of its predicates. Democrats basically want that present transvaginal mesh and other medical devices “do not mimic the mistakes made by other products.”

History should not repeat itself. LegalView supports all efforts to make these medical devices safer and more effective. For those suffering from transvaginal mesh injuries, information is available at LegalView on transvaginal mesh devices as well as legal assistance.

According to a recent article by Businessweek, The U.S. Food and Drug Administration wrote a letter to 33 vaginal mesh manufacturers, including Bard and Johnson & Johnson, requiring that the companies study the potential vaginal mesh complications and rates of organ damage. The agency requested three year trials on safety and effectiveness.

Vaginal mesh was originally approved by 501 (k) approval process, where a medical device may be FDA approved if it is similar to other products currently on the market. However in some cases, the original device used to approve newer medical devices was recalled or voluntarily pulled from the market.

Both Johnson & Johnson and Bard have been named in several vaginal mesh lawsuits nationwide, which allege severe complications from the medical device, ranging from mesh erosion, mesh shrinkage, painful sex, severe pain and other complications.

Additional information about vaginal mesh complications can be found at www.legalview.com.

In light of the recent U.S. Food and Drug Administration warnings about vaginal mesh and potential problems associated with other medical devices, the approval process has come under scrutiny.

Currently, the FDA 501 (k) approval process clears newly developed or manufactured medical devices with little testing, as long as the device is similar to another medical device already on the market, known as predicate devices. Bloomberg reports that the 501 (k) process clears close to 90 percent of all medical device applications.

However, if the predicate device is ever recalled or pulled from market due to safety concerns, the similar products given approval through the 501 (k) process are still available. The predicate device for several vaginal mesh products, Boston Scientific’s ProteGen mesh was pulled less than a year after it was approved. ProteGen mesh was used as a predicate device for Johnson & Johnson’s Gynecare TVT, which in turn was used as a predicate device for other vaginal mesh 501(k) approval applications.

These medical devices are still available on the market, even though the original device has been shown to be unsafe for consumers.

As advocates for consumer safety, LegalView urges the revamp of an outdated approval process to better serve the consumers the FDA aims to protect.

For more information about vaginal mesh lawsuits or other medical devices that have been approved via the 501(k) process with the predicate later recalled, please visit LegalView.com.

The U.S. Food & Drug Administration is responsible for pre-market testing of medication and medical devices. However, they rely on doctors and consumers to report about adverse drug side effects and complications with  unsafe products to determine whether a recall should be necessary.

People are encouraged to report their case to the FDA if they have experience any problems. For example, women began reporting complications with vaginal mesh, a synthetic medical device used in surgical procedures, which prompted the FDA to investigate the product further. The FDA has sense updated vaginal mesh from a class II to  Class III medical device, which requires more pre-market testing before it is safe for consumer groups.

Chantix, a popular aid to help people quit smoking has also been linked to increased risk of suicide or suicidal thoughts, which the FDA became aware of after people reported their case to the FDA.

If you have experienced painful or adverse side effects from medication, report it to the FDA. If you feel you are entitled to additional compensation, contact a LegalView attorney today for a FREE case consultation.