Wednesday, May 30, 2012

Transvaginal Mesh Litigation Issues: Part Two: Are the Devices Substantially Different

As a continuation of this four part series of articles on Transvaginal Mesh Litigation, we will discuss the differences in mesh devices and the impact of the surgical methods used. The defendants in these cases are seeking separation from one another in the multidistrict litigation. These defendants-- American Medical Systems, C.R. Bard, Ethicon and Boston Scientific-- are claiming the types of vaginal mesh used among plaintiffs are so different from one another that the multidistrict litigation placing all the defendants before a federal judge is improper. Further, the defendants claim that the negative outcomes of the women who received vaginal mesh implants could just as easily be related to the relative skill of the surgeons who performed the procedures. While it is true there are a wide variety of mesh devices currently on the market, the defendant’s request to look at each device as substantially different flies in the face of the procedure used to gain FDA approval.

Mesh Brands Associated With Defendants

American Medical Systems manufactures a relatively large pore polypropylene mesh under the brand names Apogee, Elevant and Miniarc while Boston Scientific’s brands fall under the Pinnacle brand. C.R. Bard manufactures the Avaulta mesh kits and Ethicon’s synthetic surgical mesh is the Gynecare brand. While transvaginal mesh implants can be made from polyester, human skin, animal tissue or polypropylene, the component used in the implants which have come under scrutiny use polypropylene--once believed to be an inert substance. Serious complications related to these synthetic mesh implants are not rare, with thousands of complications being reported and at least ten deaths tied directly to synthetic mesh vaginal implants. These tragic deaths and adverse reports certainly lend credence to the assertion by plaintiff’s lawyers that the mesh used in all these devices is substantially the same.

FDA Approval Route

Some point to a key flaw in the FDA’s 510(k) process as part of the problem in the vaginal mesh lawsuits. The current system allows manufacturers to obtain FDA approval for their product by citing the product’s similarity to a device which has already gained approval. Boston Scientific gained approval for the first vaginally implanted mesh in 1996 known as the ProteGen. Two years later, Johnson and Johnson followed suit with the Gynecare, gaining FDA approval by claiming their mesh was substantially equivalent to the ProteGen mesh. A year later Boston Scientific voluntarily pulled the ProteGen mesh implant, stating they had received over a hundred reports of problems associated with the product.

Despite this recall, Johnson and Johnson, American Medical Systems and COV came out with mesh products that were approved based on the ProteGen design. The 510(k) system is thirty-five years old, and used by the FDA as a method of reviewing almost 90% of all device applications each year. The original idea was to make the process for approving low-risk devices such as surgical drapes easier and quicker however the 510(k) system soon became the standard approval process for any medical device—including hip implants and vaginal mesh—which could claim a tie to an older product. The FDA acknowledged in early 2012 that the 501(k) process can put patients at risk, stating they would consider changes to the system this year with a goal of implementing stricter guidelines regarding which products can gain approval based on older approved products. Almost a third of the devices which are currently cleared through the 510(k) process are no longer on the market, and the FDA is unable to pinpoint the reasons many of them were pulled. There is little doubt that the approval process is flawed, however the current lawsuits assert that the manufacturers themselves should be held responsible because they were well aware of the risks of their products, yet failed to adequately warn physicians and patients of those risks.

Are Physicians Defendants in Mesh Cases?

Some have questioned why the surgeons and physicians who either recommended the mesh implants to their patients or actually performed the surgical procedure using the mesh implant bear no responsibility for the harm done to the women who received the implants. As distinguished from other medical cases, much of the time the women who received these mesh implants have long-term relationships with the doctor who recommended the mesh implant. The doctors were, in effect, the target consumer in the same way the patients were and the doctors were not given all the facts about the synthetic mesh, making it impossible for them to know or to warn their patients about potential risks. Most all of the doctors questioned stated unequivocally that if they had known of the degradation issues or that the mesh implants had not been adequately tested they would absolutely have not recommended them to their female patients.

In fact, attorneys in the multidistrict litigation are actually counting on doctors to help make their case against the defendants. Although the defendants claim that the specific skills of the surgeons who performed the mesh implants could be directly related to the failure of the implants, in many cases the patients of the highly trained surgeons who taught other surgeons the proper procedure for mesh implants have seen an equal number of problems in their female patients. Many of the lawyers involved state that of the hundreds of calls they receive from women who have been harmed by the mesh implant, a large majority of them received their surgery at the very best medical facilities in the United States yet suffered the same complications as those who were not treated at the best facilities.

While some doctors are accusing the entire gynecological surgical industry of compromising their patient’s safety in order to maximize profits and other highly trained surgeons are suggesting their less-specialized colleagues are partially to blame for the mesh implant problems, all in all the blame still lies squarely on the shoulders of the mesh manufacturers. While surgical skill is always important, the issues surrounding the mesh implants is tied more directly to the synthetic material the mesh is made from rather than the surgical procedure itself. Part three of this transvaginal mesh litigation series will cover the material which comprises the mesh implant and how it can cause medical problems for patients.

Author: Sullo & Sullo Attorneys

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