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A8 THE DAILY ASTORIAN • THuRSDAY, JANuARY 10, 2019 Physicians criticize state lawsuits over pelvic mesh By GENE JOHNSON Associated Press SEATTLE — Doctors who specialize in female pelvic medicine say law- suits by four states, includ- ing Washington and Cali- fornia, over products used to treat pelvic floor disor- ders and incontinence might scare patients away from the best treatment options — or maybe even push the prod- ucts off the market. Sixty-three Washington surgeons signed a letter to state Attorney General Bob Ferguson, arguing his con- sumer-protection lawsuit against Johnson & Johnson and its Ethicon Inc. subsid- iary is off-base. The lawsuit says the companies failed to disclose risks associated with the products, but in their letter the doctors said they were never deceived and that the case is based on a misconception about how they assess dangers posed by medical procedures. “We have served on national and regional med- ical societies in women’s health,” wrote Dr. Jeffrey Clemons, a pelvic recon- structive surgeon in Tacoma. “It is astonishing to us that the AG is proceeding with this lawsuit without first availing themselves of the significant experience and expertise of this group.” Doctors in California are drafting a similar letter to Attorney General Xavier Becerra, and the president of the American Urogyne- cologic Society, which rep- resents 1,900 medical pro- fessionals, has issued a statement expressing some of the same concerns. Clemons and two other doctors who signed the Washington letter have been retained by defense coun- sel as consultants in the case, but Clemons said he wrote it without payment or assistance from Johnson & Johnson. At issue is “transvagi- nal mesh” — plastic mesh products that are implanted to correct a variety of pelvic floor disorders. AP Photo/Ted S. Warren Dr. Jeffrey Clemons, a pelvic reconstructive surgeon, holds a letter to Washington state Attorney General Bob Ferguson that he helped draft and was signed by more than 60 surgeons. AP Photo/Ted S. Warren A sample of transvaginal mesh used to treat pelvic floor disorders and incontinence in women. They came on the U.S. market in the late 1990s to treat stress urinary inconti- nence — a condition trig- gered by physical activity like coughing, sneezing or running that is common and sometimes debilitating in women after childbirth. The treatment involves using a thin mesh strip, called a “mid-urethral sling,” to sup- port the urethra, the tube that carries urine away from the bladder. The products were so successful — one of the most significant advances in women’s health in recent decades, the physicians said — that companies began developing similar mesh products to treat another condition, called pelvic organ prolapse. In such cases, pelvic organs such as the uterus and bladder drop from their nor- mal position due to muscle weakening. A sheet of mesh can be used to support the pelvic floor. However, treating pelvic organ prolapse with mesh proved problematic after those products were intro- duced in 2004. They were more likely to bring seri- ous complications, includ- ing permanent incontinence, severe discomfort and an inability to have sex. The U.S. Food and Drug Administration issued warn- ings in 2008 and 2011, and companies pulled most of the transvaginal mesh prod- ucts for organ prolapse from the market. Tens of thousands of women have filed liabil- ity claims against Johnson & Johnson and other com- panies, with some saying they knew nothing about the potential complications. The doctors say Wash- ington’s lawsuit conflates the acceptable risks of using pelvic mesh to treat incon- tinence with the less tolera- ble risks of using it for pel- vic organ prolapse. They’re worried it could force mid-urethral slings off the market, though the attorney general’s office says that’s not the goal. Washington, Califor- nia, Kentucky and Missis- sippi are pursuing lawsuits that claim Johnson & John- son deceived doctors and patients, and that the sur- geries ruined some wom- en’s quality of life. They say product marketing brochures and instruction pamphlets should have contained much more detail about the risks. The company updated its instruction pamphlets in 2015 — effectively admit- ting the earlier versions were inadequate, Washing- ton state says. “The purpose of our law- suit is to require Johnson & Johnson to disclose to doc- tors and patients the serious risks associated with sur- gical mesh,” Ferguson said in an emailed statement. “Johnson & Johnson knew about these risks for years and misrepresented them for more than a decade, even as it sold thousands of these devices in Washington.” Washington’s lawsuit seeks fines for each alleged violation of the state’s Con- sumer Protection Act, an amount that could easily run into the millions. The attor- ney general’s office also wants to bar Ethicon from representing that its surgi- cal mesh is superior to tra- ditional treatments, such as repair using the patient’s tis- sue, and it says a key ques- tion is whether the pamphlets could have deceived the least sophisticated surgeons, not the most sophisticated. In their letter last month, the surgeons insist they were never misled — nor could they have been, because they don’t rely on a com- pany’s marketing materials or instruction pamphlets to divine the risks of medical devices. Instead, the letter said, they rely on their education, journals, conferences, text- books and other unbiased sources, and they counsel their patients accordingly. In declarations filed in King County Superior Court, some said Ethicon paid for them to undergo training that fully explored the devices’ risks, and oth- ers said they learned about the uses and risks from those specially trained doctors. Clemons and the other surgeons do not dispute that some women have suffered complications from the use of mesh to treat inconti- nence, but they say any sur- gery has risks, and the risks of that procedure are well within accepted norms. Millions of women world- wide have been treated with mid-urethral slings. The letter cited a recent large study of the English National Health Service database that found com- plications prompted the removal of mesh slings in just 1.4 percent of patients within the first year after sur- gery, 2.7 percent within five years and 3.3 percent within nine years. In fact, Clemons said, the mid-urethral sling has become the “gold standard” among surgical options for stress urinary incontinence because it offers better out- comes than other types of surgery, can be performed on heavier patients who oth- erwise would be ineligible for surgery, and requires less cutting and recovery time. The Washington Attorney General’s Office said in a court filing the fact that doc- tors obtain also risk infor- mation elsewhere does not excuse the companies from ensuring their instructional pamphlets are “truthful and complete.” The office agreed that many women have had pos- itive outcomes with the devices and said it does not seek to restrict access to them. Nevertheless, the state is relying on an expert wit- ness, Dr. Bruce A. Rosenz- weig, a gynecologist at Rush University Medical Center in Chicago, who insisted in a deposition that polypro- pylene mesh is an “unsafe material to be placed perma- nently in the female pelvis.” That position is contrary to the scientific literature, according to the surgeons’ letter. Clemons is a retired Army colonel who spent a decade as the chief of urogy- necology and pelvic recon- structive surgery at Madigan Army Medical Center. He serves on the board of the American Urogynecologic Society and has performed about 1,250 mid-urethral sling surgeries; he used to cut his own mesh slings before Ethicon’s came on the market. After filing the law- suit, the Washington Attor- ney General’s Office tried to recruit him as an expert wit- ness, he said. Although he is a fan of Ferguson’s Demo- cratic politics — Clemons donated $550 to his re-elec- tion campaign last month — he declined. “I’m not anti-Bob Fer- guson at all,” Clemons said. “I just disagree with him on this.” CL ASSIF IE D M ARK ETPL A CE P lace classified ad s o n lin e at w w w .d ailyasto rian .co m o r call 503-325-3211 107 Public Notices 181 Lost & Found 622 Vacation Rentals Occasionally other companies make telemarketing calls off classified ads. These companies are not affiliated with The Daily Astorian and customers are under no obligation to participate. If you would like to contact the attorney general or be put on the do not call list, here are the links to both of them Complaint form link: http://www.doj.state.or.us/ finfraud/ FOUND AT PETER PAN MARKET Seaside Ocean Cottage A small town newspaper with a global outlook One of the Pacific Northwest’s great small newspapers T HE D AILY A STORIAN www.dailyastorian.com CASH IN ENVELOPE COME IN PERSON TO IDENTIFY. 504 Homes for Sale 651 Help Wanted All real estate advertising in this newspaper is subject to the Fair Housing Act which makes it illegal to advertise “Any preference, limitation or discrimination based on race, color, religion, sex, handicap, familial status, or national origin, or an intention to make any such preference, limitation or discrimination.” Familial status includes children under the age of 18 living with parents or legal custodians; pregnant women and people securing custody of children under 18. This newspaper will not knowingly accept any advertising for real estate which is in violation of the law. Our readers are hereby informed that all dwellings advertised in this newspaper are available on an equal opportunity basis. To complain of discrimination call HUD at 1(800)669-9777. The toll free telephone number for the hearing impaired is 1(800)927-9275. Reach the entire North Oregon and Southwest Washington coasts with our classified package options! Call 503-325-3211 for more information. 604 Apartments SPECIALTY SERVICES W E URGE YOU TO PATRONIZE THE LOCAL PROFESSIONALS ADVERTISING IN T HE D AILY A STORIAN S PECIALTY S ERVICES . T O PLACE YOUR S PECIALTY S ERVICES AD , CALL 325-3211. CASH buyers are reading your classified ad. $1,500 p/month Month-to-month contract. 160 Columbia Near bridge. One large bedroom, Top floor w/stairs. All utilities paid. No smoking or pets. References. $900-$950 Ward 503-680-4210 Jolly Roger Oysters Looking for Seed Bag Loaders. $16 p/hr 40hrs p/week 7am -3:30pm Contact office for questions. 360-665-4111 Apply in person. Full-Time Employment Immediately hiring MEDICAL ASSISTANT for private family medicine office. Competitive benefits and wage. E-mail or bring resume to Wimahl Family Clinic, 2120 Exchange St, Ste 209. Astoria, OR. 503-338-2993 wimahlfc@aol.com Full-Time Employment Hiring FAMILY NURSE PRACTITIONER or PHYSICIAN ASSISTANT for small 3 provider Wimahl Family Clinic. Focus on quality of care and job satisfaction. Competitive salary and 4 day work week. Oregon license and experience are required. Astoria, OR. 503-338-2993 wimahlfc@aol.com UPGRADING? Sell your used equipment fast, by listing it in The Daily Astorian classified section. Call 503-325-3211. IMMEDIATE OPENING Accounting and income tax firm in the Astoria Area seek- ing seasonal or part-time experienced accountant or bookkeeper. Flexible hours available. Please send resume to Blind Box 78 and send replies to c/o The Daily Astorian, P.O. Box 210, Astoria, OR 97103 651 Help Wanted PIANIST OR ORGANIST WANTED FOR SUNDAY WORSHIP AT OCEAN BEACH PRESBYTERIAN CHURCH 11 A.M. 2 bedrooms. Washer/dryer, stove, fridge, off street parking. Utilities paid. Close to Downtown. 612-300-0420 PUBLISHER’S NOTICE 651 Help Wanted Full-Time Employment Condo/Hotel need dependable Hskpr & Maint ASAP! Wages DOE-Highest in Area-Great place to work-come join us! Seaside, OR. 503-738-9468 info@seaside-tradewinds.com The City of Astoria is now accepting applications for the full-time position of Utility Worker I or II. Pay range is 19.91-24.19 (Utility Worker I) or 22.05-26.81 (Utility Worker II) with excellent benefits. To apply and obtain further information, please go to the City’s application website at https://astoria.applicantpool. com/jobs/. If you need assistance, please contact Human Resources at 503-298-2434 or hr@astoria.or.us. APPLICATION DEADLINE: January 18, 2019. Classified Ads work hard for you! Paid position. Call 360-244-5178 651 Help Wanted Accepting Expert House Cleaners Starting at $17.50/hour or $15/hr Base plus Benefits Eco-friendly Cleaning Solutions Quality Cleaning Equipment 35+ hrs & 2 days off/wk or Part-Time Benefits; Health Insurance, Bonuses, 2 weeks Vacation/Sick, Mileage, Tips, Cell Phone, IRA Background Check Englund Marine seeks an Office/Marketing Assistant. Must be able to multi-task and have excellent attention to detail skills. Visit our website at https://www.englundmarine. com/pages/employment. html for more details. Send resume to hr@englundma- rine.com. 503.828.9889 www.KukuiHouse.com SHOP LOCAL! Check the Business Directory daily to utilize the local professionals advertising in The Daily Astorian. To place an ad in our Business Directory, call 503-325-3211. www.DailyAstorian.com
