Articles Tagged with attorneys

The FDA met last week to determine whether surgical mesh inserted surgically inserted into the vagina, also known as transvaginal mesh or pelvic mesh, needs tighter regulation by the FDA. The mesh is used to treat a painful condition called pelvic-organ prolapse. As the result of close to 3000 reports of adverse events, including seven deaths, the manufacturer – Johnson & Johnson now faces several lawsuits across the country.

Transvaginal mesh – like many other defective medical products – was allowed on the market as the result of an expedited regulatory process. The pelvic mesh is currently considered a Class II medical device and was allowed a quick entry into the market without preclinical testing if manufacturers were able to show that the devices is “substantially equivalent” to an existing device on the market.

The FDA is evaluating whether to change the classification of the transvaginal mesh to Class III – high risk. If the FDA changes the rating, the pelvic mesh would require additional testing and be subject to a longer approval period.

Based on initial reports of the transvaginal mesh hearings, it appears that the advisory committee is in favor of stricter testing requirements. A number of risks are associated with the mesh, including organ perforation and bleeding, long-term mesh exposure to the bladder, vagina and rectum, pain and infection, urinary problems, as well as the need for additional revision surgeries. Several reports also indicated that the use of the mesh exposes patients to “unnecessary risk without a benefit above safer options.”

As New Mexico transvaginal mesh lawyers, we support tougher regulations. Too often innocent patients are injured due to defective medical devices that are rushed to market.
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Recently the FDA issued a transvaginal mesh warning concerning the use of the medical device (also known as pelvic mesh, pelvic sling or bladder mesh) as a method to repair pelvic organ prolapse. The FDA warning stated that using transvaginal mesh to repair pelvic organ prolapse exposes patients to an “unnecessary risk” without providing any benefit above safer measures. Next week, the FDA will conduct hearings to determine whether stricter safety measures or a possible recall of the transvaginal mesh is necessary.

Problems from the medical device include pain, bleeding, infection, injury to nearby organ, and protrusion of the mesh through the vagina.

If you have undergone surgery for pelvic organ prolapse and surgeons used the pelvic mesh, it is important to consult with a transvaginal mesh attorney regarding your next steps.

According to an FDA representative, “There are clear risks associated with the transvaginal placement of mesh…The FDA is asking surgeons to carefully consider all other treatment options and to make sure that their patients are fully informed of potential complications from surgical mesh.” This warning came after the FDA received reports of 1503 adverse events from 2008 to 2010.
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More and more claims concerning the troubled DePuy Hip continue to emerge. A recent article reveals that in additional to extreme pain from the faulty medical device, other symptoms related to metal poisoning occurred. According to one DePuy Hip patient – Tony Stauffer – discussed in the San Diego news, his hair started to fall out, he got skin rashes and his fingernails became brittle. These symptoms were linked to metal flakes coming loose from the joint with movement that caused metal poisoning. The metal poisoning then inflamed his hip joint and damaged his muscles.

If you have undergone hip replacement surgery and have a DePuy Hip, it is important to contact a New Mexico DePuy hip attorney to determine your next steps.

Stauffer is one of more than 94,000 DePuy Hip patients around the world who have received the implant. Lawsuits resulting from the defective medical device have been filed in New Mexico and around the country. Many blame the DePuy Hip problems both on the manufacturer and the FDA fast-tracking process that allows device manufacturers to rush products to the market without first ensuring their safety.

In fact, the FDA released a statement indicating its need for post market studies after receiving reports from patients that they “have developed symptoms or illnesses elsewhere in the body including the heart, nervous system and thyroid gland that may be due to the patient’s reaction to metal ions released from the implant.”

In fact, many patients have shown increased cobalt and chromium levels. Despite the recall that occurred in August 2010, the number of patients reporting injuries, pain and discomfort continue to rise. Doctors recommend immediate DePuy Hip revision surgeries in order to correct the problem.
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A recently released medical device study concludes that the FDA should “abandon” its present system for approving U.S. medical devices such as the DePuy Hip because it fails to ensure patient safety.

Currently the FDA employs a streamlined approach to approve medical device applications such as those for the beleaguered DePuy knee and hip parts – a process that takes 10 months as opposed to several years.

However, this quick process is unreliable. As the result of a faulty or inadequate screening process, many patients with medical devices have found themselves harmed by medical devices, implanted with recalled items that require additional, painful and sometimes dangerous surgeries.

One patient who required revision surgery to fix a recalled DePuy Hip part states, “You put your faith in the doctor and the companies that make these products because they’re the experts…It’s just beyond me to think that things can get approved that don’t really work” reports ABC News.

Unfortunately, faulty medical devices are placed in patients at an alarming rate. A study from the National Research Center for Women and families found that more than 437 million devices were recalled in 2010 due to fears that they might kill and permanently harm patients.
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Please see our Avandia information page to learn about the most up to date news on the harmful diabetes drug. The attorneys and lawyers at the Branch Law Firm can help you take action against the pharmaceutical giant Glaxo Smith Kline, makers of the diabetes drug Avandia; also known as Rosiglitazone

 
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