House Democrats Call for Safety Hearings on Lap Bands and Transvaginal Mesh

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Ennis & Ennis, P.A. Supports the House Democrat’s Position in Questioning Whether FDA Medical Device Approval Process Protects the Public

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It only seems logical that the approval process be re-examined in order to save others from the pain and suffering that our clients have endured from these devices

House Democrats from the Energy and Commerce Committee, led by Representative Henry Waxman of California, urged Republicans to hold hearings to examine Lap-Band weight loss devices and transvaginal mesh devices, which have developed serious defects after being implanted. The Democratic lawmakers requested the Committee hold a hearing to examine whether the FDA device regulation has been ineffective in protecting the public from dangerous medical devices. Attorney Holly Ennis of Ennis & Ennis, P.A. commented, “A stricter approval process would potentially save thousands of consumers from suffering unnecessary and serious side effects caused by medical devices whose manufacturers never conducted clinical studies.”

House Democrats called on congress to not only hold hearings on Lap-Band and transvaginal mesh, but also on brain stents and metal-on-metal hip implants, which they had previously requested on October 12, 2011. They also called on the Committee to request documents from various facilities regarding their marketing of Lap-band and to seek safety and procedural documents from vaginal mesh manufacturers.

The Lap-Band is a device that is surgically implanted and wrapped around the upper portion of a patient’s stomach to reduce the size of the stomach. However according to the House Democrats' correspondence, the device can pose serious risks including erosion of the band through the stomach wall, stretching the stomach pouch, stomach pain, gastroesophageal reflux disease, difficulty swallowing, nausea, and vomiting.

Transvaginal mesh implants are permanently implanted in the vaginal wall to treat pelvic organ prolapse and urinary incontinence. These mesh devices were permitted on the market under the 510(k) clearance process, which fast-tracks medical devices onto the market without clinical testing. However, according to an FDA Safety Communication dated July 2011, these devices pose serious side effects such as vaginal mesh erosion (also called exposure, extrusion or protrusion), pain, painful sexual intercourse (also called dyspareunia), infection, urinary problems, bleeding, organ perforation, recurrent prolapse, neuro-muscular problems, vaginal scarring/shrinkage and emotional problems.

The FDA recently announced that it is considering reclassifying transvaginal mesh as a high risk Class III medical device. The FDA ordered 33 manufacturers of the device to conduct postmarket safety studies of the device.

Ennis & Ennis, P.A. strongly supports the House Democrat’s requests. “We represent hundreds of consumers who have been injured by transvaginal mesh and metal-on-metal hips. It only seems logical that the approval process be re-examined in order to save others from the pain and suffering that our clients have endured from these devices,” states Ennis.

Ennis & Ennis is offering free, nationwide, confidential consultations to anyone who has suffered as a result of a transvaginal mesh device or a metal-on-metal hip replacement system by calling toll free 1-800-856-6405 or by going to and completing an online case evaluation form.

Ennis & Ennis, P.A. is a nationwide law firm with offices in Ft. Lauderdale, Miami and Washington D.C. Ennis & Ennis, P.A. concentrates its practice in mass torts and represents individuals against pharmaceutical companies as well as medical device makers.

Ennis & Ennis, P.A. has been representing clients individually since 1986 and has recovered over $100 million in settlements for its clients.

Ennis & Ennis, P.A. is also investigating cases involving Accutane, Actos, Fosamax, Plavix, Zoloft, Prozac, Depuy Hip Recall, Zimmer Hip Recall, Depakote, Reglan, SJS/Dilantin, Yaz, Yasmin, Ocella Birth Control Pills, and Transvaginal Mesh Devices.

Remember the law limits the time in which you can file a claim, so don't wait to explore your legal rights. Call today toll free 1-800-856-6405 or visit


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Attorney Holly Ennis