Parker Waichman LLP, a national law firm, just filed a lawsuit on behalf of a Colorado woman allegedly injured by transvaginal mesh products manufactured by American Medical Systems, Inc. The suit was filed on May 21, 2012 in the U.S. District Court for the Northern District of California (Case No. 3:12-cv-02613-RS).
According to the complaint, the Pueblo County, Colorado, woman received an American Medical Systems’ Perigee System with InteXen LP and the Apogee System with InteXen LP on May 19, 2010. The woman claims that the mesh—used to treat her pelvic organ prolapse (POP) and stress urinary incontinence (SUI)—has caused her to sustain significant mental and physical pain and suffering, permanent injury, permanent and substantial physical deformity, loss of bodily organ systems. The complaint also states that the woman has undergone or will undergo corrective surgery or surgeries.
Parker Waichman LLP noted that American Medical Systems received approval for its transvaginal mesh products through the U.S. Food and Drug Administration’s (FDA) 510(k) process, which allows devices to be sold with no formal review provided that the product is deemed “substantially equivalent” to similar devices marketed before May 28, 1976. The 510(k) program is a frequent target of critics who say it is too lax and, last summer, the Institute of Medicine issued a report highlighting deficiencies with 510(k) clearances and recommended that the FDA scrap the program entirely. Several types of medical implants approved via 510(k) protocols have been the subject of complaints, safety reviews, and lawsuits. Chief among these are transvaginal mesh devices
Meanwhile, this lawsuit alleges that American Medical Systems, Inc. knew or should have known that its transvaginal mesh products could cause complications such as vaginal erosion, infection, extrusion, perforation, chronic pain, and/or abscess prior to marketing the devices to the public. Dozens of transvaginal mesh lawsuits against American Medical Systems have already been consolidated in a multidistrict litigation (MDL No. 2325) in the U.S. District Court for the Southern District of West Virginia. Proceedings will take place before Judge Joseph R. Goodwin.
Between January 1, 2008 and December 31, 2010, the FDA received 2,874 reports of injuries associated with transvaginal mesh, including vaginal erosion, pain, infection, bleeding, painful sexual intercourse, urinary problems, and organ perforation. On July 13, 2011, the FDA announced that such complications associated with transvaginal mesh products are not rare. Furthermore, the agency stated that it is uncertain whether such devices provide any benefit over traditional non-mesh procedures used to treat POP and SUI, and may actually pose greater risks. The announcement amends the agency’s previous position in October 2008, when it stated that complications were potentially serious, but uncommon.
Also, last September, the FDA’s Obstetrics and Gynecology Devices Advisory Panel recommended that transvaginal mesh products be reclassified from moderate to high risk, which prevents the devices from going through the 510(k) process and requires formal clinical testing as a prerequisite for approval.
Another transvaginal mesh device maker, Boston Scientific, is facing nearly 300 lawsuits over injuries allegedly caused by its mesh products. About 170 Boston Scientific transvaginal mesh lawsuits have been consolidated in a federal multidistrict litigation in Charleston, West Virginia, along with similar suits against C.R. Bard, Johnson & Johnson and American Medical Systems. Boston Scientific has also been named more than 100 additional transvaginal mesh injury claims pending in Massachusetts state court in Middlesex County.
In January 2012, the FDA ordered 33 manufacturers, including American Medical Systems, Johnson & Johnson, and Boston Scientific, to conduct post-market studies assessing the impact of transvaginal mesh products on organ damage and other associated problems.
European regulators have completed another Pradaxa review, and are recommending that the blood thinner’s label be updated with new safety information regarding Pradaxa bleeding side effects. The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) said the Pradaxa label should include new guidance as to when the blood thinner should not be used. The Committee also wants Boehringer Ingelheim to include advice on managing patients and reversing Pradaxa’s blood thinning effect if bleeding occurs.
In November, CHMP asked that Boehringer Ingelheim include more label information on Pradaxa bleeding side effects. The Committee also advised that Pradaxa should be used with caution, and at lower doses in the elderly and kidney patients. At the time, around 250 Pradaxa bleeding deaths had been reported to Boehringer Ingelheim.
Recently, European regulators expanded Pradaxa’s approved uses to include patients with non-valvular atrial fibrillation to prevent stroke and systemic embolism. According to a report from Pharma Times, the number of fatal bleeding events among Pradaxa users spiked following that expansion.
In a statement issued today by the CHMP, patients taking Pradaxa were advised to be aware that they are at an increased risk of bleeding. If they fall or injure themselves during treatment, especially if they hit their head, they should seek urgent medical attention.
Prescribers were reminded of the need to follow all the necessary precautions with regard to the risk Pradaxa bleeding including the assessment of kidney function before treatment in all patients and during treatment if a deterioration is suspected, as well as dose reductions in certain patients. Pradaxa must not be used in patients with a lesion or condition putting them at significant risk of major bleeding, the Committee said.
Pradaxa was the first of a new class of blood thinners called direct thrombin inhibitor that are being touted as safer alternatives to warfarin. However, while severe bleeding side effects from warfarin can be stopped via the administration of vitamin K, there is no readily available antidote to Pradaxa bleeding.