FREE CASE EVALUATION: 1-800-632-1404
Tens of thousands of women receive a transvaginal mesh (TVM) device each and every year from numerous suppliers: American Medical Systems, Bard, Boston Scientific, Ethicon,Gynecare, and Johnson & Johnson. Thousands of women have been injured through no fault of their own, including vaginal erosion, pain, urinary problems, bleeding, infection and more. Our attorneys are representing women in all fifty states and Canada who have been injured. For a free case evaluation, call 1-800-632-1404.
We are honored to have two women on staff ready and willing to discuss the facts of your case with you as often as needed.
House of Representatives Looking for Hearings and Issue Letter
Bloomberg News reports that
House Democrats called for congressional hearings on transvaginal meshes of the kind made by Johnson & Johnson, saying the devices are hazardous to patients. U.S. Representative Henry Waxman, a California Democrat, and three colleagues urged Republicans who control the House Energy and Commerce Committee to hold the hearing and demand documents from manufacturers. The inquiry is critical as Congress considers an overhaul of Food and Drug Administration rules for medical devices, the Democratic lawmakers said today in a statement. The FDA ordered New Brunswick, New Jersey-based J&J and 32 fellow manufacturers to conduct safety studies of the vaginal implants earlier this month, citing reports of internal injuries.
The Democratic Committee Leaders issued a letter stating:
We are writing to renew our October 12, 2011, request for hearings to examine medical devices that have developed serious defects after being implanted in patients and to propose the Committee seek documents related to the “Lap-Band” weight loss device and urogynecologic surgical mesh. The Committee has failed to schedule the hearing we requested in our October 12 letter, and we remain concerned that the Committee’s previous hearings on medical devices have presented a skewed and inaccurate picture of the importance of appropriate medical device regulation. We hope you will reconsider your approach so that the Committee can have a fuller understanding of these critical issues as we prepare to reauthorize the Medical Device User Fees Act.
The “Lap-Band” Gastric Band
The “Lap-Band” is a type of gastric band device that is surgically implanted and wrapped around the upper portion of a patient’s stomach to reduce the size of the stomach. When the device is effective, patients feel full more quickly and thus are more likely to eat less and lose weight. FDA approved the “Lap-Band” device for obese patients, but has indicated that the device can pose serious risks including erosion of the band through the stomach wall, stretching the esophagus, stretching the stomach pouch, stomach pain, gastroesophageal reflux disease, difficulty swallowing, nausea, and vomiting.[1] In addition, the FDA has said the device is not a “quick fix” for patients struggling with obesity but instead requires “major, long-term changes” to eating habits.[2]
A study published this week in the Archives of Surgery raised questions about the effectiveness of gastric banding, finding that after six years, nearly 50% of patients had either not lost weight or had needed the device to be removed and that over 40% of patients experienced long-term complications.[3] The study echoed research published in the journal’s March 2011 edition, which found that 40% of patients who received “Lap-Band” surgery had serious complications and concluded that the surgery had “relatively poor long-term outcomes.”[4] Similarly, a study in the Journal of the American Medical Associationreported that 48% of test group members experienced “adverse events” as a result of the procedure and that nearly 30% required “revisional procedures” to enlarge the stomach above the band.[5] A study in the Journal of Obesity found high complication and reoperation rates for gastric banding, with 30% requiring an additional operation and 12% requiring the removal of the device altogether.[6]
Even in the face of these serious medical complications, Allergan, the manufacturer of the Lap-Band, is seeking to expand the use of the device in children and young adults. Allergan is currently seeking FDA approval to market the device to children as young as 14, despite concerns among some physicians that the procedure is too drastic or “extreme” for a young person’s developing body.[7] The New York Times recently reported that the lure of a seemingly “easy way out” of losing weight may push young people to undergo “Lap-Band” surgery without adequately considering the risks and the dramatic lifestyle changes that are necessary.[8]
The adverse public health consequences associated with use of this device are exacerbated by aggressive marketing and by the lack of a national registry of implanted medical devices, like those that exist in Europe, which would enable public health authorities to obtain more accurate data on the rates of adverse events and device failures.
The tragic results of aggressive marketing by several Lap-Band surgical centers are particularly evident in recent events in Southern California. In December 2011, FDA issued warning letters to a marketing firm called 1-800-GET-THIN, LLC, and eight surgical centers in California that aggressively market the Lap-Band without adequately informing consumers of the risks associated with the device. [9] According to a series of reports in the Los Angeles Times, the use of lap-bands by these surgical centers appears to have been associated with significant harm to the health of a number of Southern California patients, including the deaths of five patients since 2009.[10]
Despite these serious risks, 1-800-GET-THIN and the related surgical centers have marketed the device with ubiquitous roadside billboards, advertising inserts, and radio and television ads that “display the smiling faces of thin people and catchy phrases about the benefits” of the surgery.[11] The ads include phrases such as “DIETS FAIL! The Lap-Band Works!” and “Let Your New Life Begin.”[12]
The advertisements either do not mention the risk information, qualifying age and weight requirements for the procedure, and the need for meaningful life style change or they present limited information in lettering the FDA called “so small as to render the information illegible.”[13] One FDA official said he was “astonished” by the number of billboards advertising the procedure and noted that the ads target “a very vulnerable patient population.”[14]
Although Allergan has criticized the advertising campaign and issued voluntary advertising guidelines for the “Lap-Band” in February 2011, these voluntary guidelines have not been effective. It is unclear what, if any, direct action Allergan took to prevent 1-800-GET-THIN or the related surgical centers from advertising the “Lap-Band” in a false and misleading way.[15]
Urogynecologic Surgical Mesh
Urogynecologic surgical mesh implants are permanently implanted in the vaginal wall of patients suffering from conditions such as pelvic organ prolapse and urinary incontinence in order to repair weakened or damaged tissue.[16] These mesh devices were permitted on the market under the 510(k) clearance process, meaning that the devices had to demonstrate that they were “substantially equivalent” to one or more devices already on the market. Although clinical data can be required under this clearance process, many submissions are cleared without such data. FDA did not require original clinical studies before clearing urogynecologic surgical mesh through the 510(k) process.[17]
Beginning in October 2008, FDA began to respond to rising reports of complications associated with the surgical mesh by issuing a Public Health Notification calling the transvaginal placement of the mesh “an area of continuing concern.”[18] In the three years before the notification, over 1,000 adverse events related to the mesh had been reported to FDA.[19] Over the next three years, the number of reported complications rose to more than 2,800, driving FDA to issue an update on the “serious complications” associated with the device in July 2011.[20]
In 2010 alone, nearly 300,000 synthetic vaginal meshes were implanted in American women.[21] The most common complication associated with the device is erosion through the vagina, which can be potentially debilitating for some women and require multiple surgeries to correct. [22] Even with multiple surgeries, some women are never able to recover from the damage.[23]
After years of reports of serious complications associated with use of the device and amid a rising chorus of academic and clinical concern, FDA just last week announced that it was considering reclassifying vaginally implanted surgical mesh as a high risk Class III medical device. [24] The agency ordered 33 manufacturers of the device to conduct postmarket safety studies of the device.[25]
It is unclear when the manufacturers of this device became aware of the serious health risks associated with the device. It is also unclear if the manufacturers and the FDA have taken appropriate steps to protect patients.
Conclusion
We believe the Committee should hold hearings to examine whether FDA device regulation has been ineffective in protecting the public from dangerous medical devices like the Lap-Band and intravaginal mesh. We also believe we should hold hearings on the brain stents and metal-on-metal hip implants mentioned in our October 12 letter.
We further ask that the Committee seek documents relevant to both the Lap-Band and intravaginal mesh devices. In the case of the Lap-Band, we urge you to request documents from Allergan, 1-800-GET-THIN, LLC, and the eight surgical centers named in the FDA’s warning letters to learn the degree to which these entities cooperated in the marketing of the Lap-Band, what steps were taken to minimize the risks the aggressive marketing campaign posed to patients and children in particular, and to obtain additional information regarding their knowledge of and response to device failures and adverse events. In the case of the intravaginal mesh, we ask that the Committee seek documents from the manufacturers of surgical mesh to ascertain when they first learned of the safety issues associated with certain uses of the device and what, if any, actions they took to limit risks for patients.
As the Committee approaches reauthorization of the Medical Device User Fee Act, we need to understand the safety of devices on the market, the tactics device manufacturers and others use to market these devices, and the extent to which these tactics may increase risks. It is also vital that we understand whether device manufacturers and the FDA are taking appropriate steps to keep hazardous devices from the market and to protect patients from marketed devices that are later discovered to be dangerous.
The Committee’s reauthorization of the Medical Device User Fee Act is an important opportunity to improve the efficiency of the FDA’s review process while at the same time strengthening assurances of safety and efficacy. Obtaining information about devices like the Lap-Band and intravaginal mesh will be critical to informing members of the Committee on an issue that has thus far been absent from the Committee’s record.
Our team of attorneys is reviewing case evaluations for women across the country who have received TVM and TVT products from manufactures such as C.R. Bard, Avaulta, Boston Scientific, and Johnson & Johnson’s Ethicon.
If you need help from a transvaginal mesh device injury, call us today for help.
The Problem
In 2008, the FDA first released concerns about the safety of transvaginal placement of mesh. From 2008 to 2010, the FDA received three to five times as many adverse reports associated with mesh used for pelvic organ prolapse repair than what agency received from 2005 to 2007 (nearly 1,000 reports of adverse events were received from 2005-2007).
Many of these patients complain because of erosion or contraction of the mesh material (which has been described as being of a similar material as Rubbermaid storage containers). The erosion leads to bleeding, severe pelvic pain, painful (or impossible) sexual performance and a recurrence of urinary problems.
In July 2011, the Food and Drug Administration (FDA) issued an update related to what it called ‘serious complications’ related to the use of vaginal mesh for treatment of pelvic organ prolapse (POP) and stress urinary incontinence (SUI). It is now known that complications linked to transvaginal placement of surgical mesh in SUI and POP patients are not rare and can require multiple surgeries to correct problems related to the use of surgical mesh. In fact, the FDA now says that additional surgeries may actually not be able to repair damage caused by implantation of the mesh.
In other words, the side effects of the mesh placement may be permanent. These complications from transvaginal placement of surgical mesh include:
- -Erosion of the implanted mesh
- -Infection and/or bleeding
- -Pain, including pain during sexual intercourse
- -Problems with organs near the implantation site
Helping You
You may have experienced mesh erosion, bleeding, urinary infections, vaginal scarring, pain during sexual intercourse, failure to conduct sexual intercourse and more. A physician may have tried to remove the mesh and been unable to do so. You may be in excruciating pain, and need help. We are offering free case evaluations to the general public across the United States and Canada. Manufacturers we consider include American Medical Systems, Bard, Boston Scientific, Ethicon,Gynecare, and Johnson & Johnson.
If you received a transvaginal mesh / sling and have been injured, you may be entitled to monetary compensation. Problems include pain, inability to have intercourse,bleeding, mesh growth into the body, mesh erosion, and more. Problems could be irreversible. Please fill out the form to the right or call us so that we can provide you with forms to evaluate your potential case immediately.
We are accepting case evaluations nationwide and in Canada, as well. Please do not hesitate or delay in contacating TVM / TVT Sling and transvaginal mesh attorneys :
CALL: 1-800-632-1404
EMAIL: clicking here
FILL OUT THIS FORM FOR A FREE CONSULTATION AND CASE EVALUATION:
NOTE: Our team of attorneys will review potential cases for all fifty states, including Alabama Alaska Arizona Arkansas California Colorado Connecticut Delaware Florida Georgia Hawaii Idaho Illinois Indiana Iowa Kansas Kentucky Louisiana Maine Maryland Massachusetts Michigan Minnesota Mississippi Missouri Montana Nebraska Nevada New Hampshire New Jersey New Mexico New York North Carolina North Dakota Ohio Oklahoma Oregon Pennsylvania Rhode Island South Carolina South Dakota Tennessee Texas Utah Vermont Virginia Washington West Virginia Wisconsin and Wyoming.