Atrium C-QUR™ hernia mesh is a medical device manufactured by Atrium. Atrium Medical Corporation is a business unit of Maquet Cardiovascular located at 40 Continental Boulevard in Merrimack, NH. Many victims allege that C-Qur mesh is defective, unreasonably dangerous and that Atrium failed to warn them of the dangers of the mesh device. Lawsuits have been consolidated into “Multidistrict litigation*” pending before the UNITED STATES DISTRICT COURT FOR THE DISTRICT OF NEW HAMPSHIRE. In 2016, the Atrium hernia mesh lawsuits pending in Federal Courts were centralized by a Federal Court Judicial Panel see: In re: Atrium Medical Corp. C-QUR Mesh Prods. Liab. Litig., 223 F. Supp. 3d 1355 (J.P.M.L. 2016).
United States District Judge Landya McCafferty is presiding over these medical device lawsuits. Thankfully, there are no c-qur class action lawsuits pending in the United States. There is currently no C-Qur recall, at this time, and no global C-Qur mesh settlement. There is no way to know what an average C-Qur settlement will be in the future. Will there be a C-QUR settlement?
Update- 7-7-21- “Currently, the first in-person federal trial is still scheduled to occur on July 7, 2021, to be followed by additional state and federal bellwether trials.” National law review
4-2-21- In the case of Cosh v. Atrium Med. Corp., 2021 U.S. Dist. LEXIS 59649 (SDNY April 2, 2021) the Atrium hernia mesh lawsuit was dismissed by the New York Court. “Under New York law, a claim for design defect must be supported by a showing of a safer, feasible alternative product.” Lex Blog The victim failed to establish a safer alternative and the lawsuit was dismissed. “The plaintiff alleged that the defendant “could have used heavyweight small-pore mesh instead of midweight mesh or non-woven mesh instead of a knitted or woven mesh,” but did “not allege facts showing this would be technically and economically feasible and result in a safer design.” Id. This was the 2nd time the victim’s cause of action was dismissed.
3/15/21- There are 2,624 C-Qur lawsuits pending in the MDL.
6/06/2020- As of May 15, 2020, there were 2109 c-qur hernia mesh lawsuits pending in the Multidistrict Litigation. The first C-QUR bellwether case is scheduled for May 20th, 2020 in The UNITED STATES DISTRICT COURT FOR THE DISTRICT OF NEW HAMPSHIRE. On December 19, 2019 United States District Judge, Landya McCafferty issued an ORDER REGARDING SELECTION OF PLAINTIFFS FOR TRIAL AND MISCELLANEOUS PRE-TRIAL MATTERS which stated, “The first case tried on May 20, 2020, shall be limited to a single case (that is, a single plaintiff and his or her spouse, if applicable). The parties shall attempt to reach agreement on the first case to be tried (between the two cases selected by the parties), the manner of trial (e.g., length of trial), and the timing of the trial of the second case to be tried (which shall be the remaining case of the two cases selected by the parties). On February 7, 2020, the parties shall submit a report to the Court indicating those matters as to which agreement has been reached and setting forth their positions as to all matters where agreement was not reached. If agreement is not reached on the first case to be tried, the Court will select from the two cases chosen by the parties, and will address other matters of disagreement, on or before February 28, 2020.”
3/5/20- Justice McCafferty issued the THIRD AMENDED CASE MANAGEMENT ORDER 3C which stated, “Counsel for Plaintiffs and Counsel for Defendants have met and conferred regarding amendments to the Collection, Preservation, and Division of Pathology Material Pretrial Order No.3C.”
See: Jean A. Downie v. Atrium Medical Corporation, No. 226-2013-cv-00155 (N.H. Super. Ct.)
Types of Atrium hernia mesh we are reviewing for lawsuits:
- C-Qur (entire line except for C-Qur FX & C-Qur CentriFX)
- C-Qur Mosaic
- C-Qur Edge
- C-Qur TacShield
- C-Qur Lite Mesh V-Patch
- C-Qur Mesh V-Patch
- Prolite Ultra
No C-QUR settlement yet
No global settlement has been achieved by the hernia mesh lawsuit attorneys as of this date.Sadly, C-Qur hernia mesh has caused severe pain and suffering and complications in scores of victims across the United States and Canada. If you are in need of a hernia mesh lawyer, contact the best hernia mesh lawsuit law firm in the United States.
Contact a hernia mesh attorney at a mesh law firm
This hernia mesh post about Atrium C-QUR™ mesh manufactured by atrium medical corporation was written to provide hernia mesh victims information about hernia mesh litigation and lawsuits. If you have further questions about Atrium C-Qur hernia mesh, please contact a hernia mesh attorney at the number on this site. This legal article provides comprehensive information about: who, what, where and how of Atrium C-Qur hernia mesh and the resulting lawsuits. This surgical mesh website also provides information about the following: “hernia mesh settlement 2020” as well as “the average settlement amount for a hernia mesh lawsuit 2020.” Victims are still, to this day, filing C-Qur hernia mesh lawsuits. It is crucial that individuals not miss a c-qur statute of limitations deadline. A victim who misses a C-qur mesh deadline may be precluded from filing a C-qur hernia mesh lawsuit. C-qur mesh complications are very serious and a victim should not wait too long before filing an Atrium mesh lawsuit otherwise known as a C-qur mesh lawsuit.
WHO is pursuing Atrium C- QUR™ lawsuits in Federal Court?
We are reviewing Atrium C-QUR™ claims (Lap – no FX) for potential individual lawsuits in United States Federal Courts. These Atrium C-QUR™ cases manufactured by atrium medical corporation are pending before the UNITED STATES DISTRICT COURT FOR THE DISTRICT OF NEW HAMPSHIRE. The Honorable United States District Judge Landya McCafferty is presiding over these medical device product liability claims. The Court is located at the U.S. District Court District of New Hampshire. The Court is located at 55 Pleasant Street Room 110 Concord, NH 03301, 603.225.1423.
The official case caption for the MDL is: In Re: Atrium Medical Corp. C-QUR™ Mesh Products Liability Litigation (MDL No. 2753) MDL Docket No. 16-md-2753-LM The Atrium C-QUR™ causes of action have been consolidated “for pretrial purposes” as multi-district litigation. (otherwise known as an “MDL”)
C-Qur mesh lawsuit
There was a case management order of May 29th, 2018. On July 9th, 2018 it was reported: “Complaints are being added at an increasing rate in U.S. District Court class action litigation against Atrium Medical Corp, a medical device firm that employs 600 people in Merrimack. At midyear, 784 plaintiffs were involved in 621 federal cases from around the country, all alleging that Atrium’s hernia mesh products had painful and sometimes fatal complications. The suits, which began being filed in August 2016, were consolidated at the end of that year in U.S. District Court in Concord. Over the last six months, they were filed at a rate of 39 a month, compared to 24 per month previously. That doesn’t count over 100 cases filed in New Hampshire Superior Court.” https://www.nhbr.com/July-20-2018/Filings-gain-momentum-in-hernia-mesh-litigation/ “Few of the federal plaintiffs are from New Hampshire, even those filed directly in Concord. The last half dozen were from Kansas, Texas and Mississippi.” Id.
c qur mesh: Case management and settlement conferences
This case management order determined that bellwether trials will commence starting February 19th, 2020. “The litigation’s bellwether trials will involve a small group of representative cases and may provide insight into how other juries will rule in similar claims.” RX injury
There will also be a settlement conference for the first bellwether trial prior to January 6, 2020. “The May 29th Order further directs counsel for plaintiffs and defendants to each select 8 cases (for a total of 16) for inclusion in an Initial Discovery Pool by July 20, 2018. Hernia mesh lawsuits eligible for the pool include those filed on or before April 1, 2018 that have plenary jurisdiction in the District of New Hampshire.” Id.
“Half of the cases selected for the Discovery Pool will be designated Trial Pool Cases by March 1, 2019 and will proceed to expert discovery. Plaintiffs are to select 4 of the Trial Pool Cases, while defendants will select the remaining 4. The parties are encouraged in making selections for Discovery Pool and Trial Pool cases to select cases that will be representative of all filed cases in order that the process of selection and trial will be a helpful process for evaluation of the entire docket of cases for trial and resolution of the entire docket of cases,” the Order states.” Id.
Complaints and procedural order
- Atrium C-QUR lawsuit- Long form complaint
- In Re: Atrium Medical Corp., C-Qur Mesh Products Liability Litigation MDL No. 2753 – short form complaint
- MASTER ANSWER AND JURY DEMAND OF DEFENDANT ATRIUM MEDICAL CORPORATION TO MASTER COMPLAINT
- Procedural order of 4/20/18
Orders have issued from the courts deciding individual Atrium C-QUR lawsuits?
According to the Atrium Medical C-Qur Case Management Order #1, The Court ordered that: “The actions listed in Attachment A are consolidated for pretrial purposes. Any “tag-along” actions later removed to or transferred to this court, or directly filed in this court, will automatically be consolidated with this action without the necessity of future motions or orders. This consolidation, however, does not constitute a determination that the actions should be consolidated for trial, nor does it have the effect of making any entity a party to any action in which he, she, or it has not been named, served, or added in accordance with the Federal Rules of Civil Procedure.” CASE MANAGEMENT ORDER NUMBER 1, January 13, 2017
The 2nd Atrium medical C Qur Case Management order declares that, “In order to eliminate delay and to promote judicial efficiency, any plaintiff whose case would qualify for transfer to MDL No. 2753 under the Judicial Panel on Multidistrict Litigation’s December 8, 2016 transfer order (doc. no. 1) may file his or her complaint directly in MDL No. 2753 in this court. Defendants reserve the right to object to the inclusion of any such action in this MDL.” CASE MANAGEMENT ORDER NO. 2 (Direct Filing and Waiver of Service)
What is multi-district litigation (MDL)?
“Multi-district Litigation is litigation comprised of multiple civil cases involving one or more common questions of fact which have been transferred by the Judicial Panel on Multidistrict Litigation from multiple federal district courts across the country to a single federal district court for coordinated or consolidated pretrial proceedings under 28 U.S.C. Section 1407.” United States District Court District of New Hampshire, MDL
WHAT are the Atrium C-QUR™ lawsuits about?
The Atrium medical C-QUR™ hernia mesh victims who have filed lawsuits in Federal Court are asserting that the Atrium C-QUR™ device manufactured by Atrium medical corporation is defectively designed. They also alleged that they were not properly warned of the device’s dangers. These litigants allege that such medical devices caused them certain complications including: Pain and suffering. Many victims allege the mesh ripped.
- Mesh migration
- Bacterial infections
- Hernia recurrence
- Additional surgeries to treat hernia recurrence
Will there be C-Qur mesh lawsuit jury trials soon?
According to the Procedural order entered on April 20th, 2018, “The parties stated in their joint agenda that they have exchanged drafts and continue to work together to finalize a proposal to submit to the court within two weeks regarding bellwether guidelines as well as pretrial and trial dates for bellwether cases selected. The parties asserted during the status conference that they continue to make progress in finalizing a proposal and do not require court intervention at this time.” UNITED STATES DISTRICT COURT
FOR THE DISTRICT OF NEW HAMPSHIRE In Re: Atrium Medical Corp. C-Qur Mesh Products Liability Litigation (MDL No. 2753)
MDL Docket No. 16-md-2753-LM, ALL CASES, PROCEDURAL ORDER
WHEN can I file a C Qur lawsuit?
You can file a hernia mesh claim after you retain a top hernia mesh attorney
WHERE are the Atrium C-QUR™ lawsuits filed?
UNITED STATES DISTRICT COURT FOR THE DISTRICT OF NEW HAMPSHIRE
Are these C-QUR™ hernia mesh cases a Class action?
No the Atrium C-QUR™ claims are individual lawsuits with each victim represented by their own hernia mesh attorney. It is important that you retain one of the best hernia mesh lawyers in the United States.
WHY did this occur?
Atrium utilized the controversial 510(k) Premarket Notification process to get C-QUR™ approved. On 03/31/2006 the FDA determined that ATRIUM MEDICAL CORPORATION C-QUR MESH aka “C-QUR™ Mesh” is “Substantially Equivalent (SESE)” to another type of mesh marketed years prior. By using the 510 (k) process Atrium avoided the strenuous testing protocol usually required by the FDA.
On March 31, 2007 the FDA wrote a letter to Atrium stating, “We have reviewed your Section 5 10(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act.” https://www.accessdata.fda.gov/cdrh_docs/pdf5/K050311.pdf
What is a 510 (k) pre-market notification process?
“Section 510(k) of the Food, Drug and Cosmetic Act requires device manufacturers who must register, to notify FDA of their intent to market a medical device at least 90 days in advance. This is known as Premarket Notification – also called PMN or 510(k). This allows FDA to determine whether the device is equivalent to a device already placed into one of the three classification categories. Thus, “new” devices (not in commercial distribution prior to May 28, 1976) that have not been classified can be properly identified. Specifically, medical device manufacturers are required to submit a premarket notification if they intend to introduce a device into commercial distribution for the first time or reintroduce a device that will be significantly changed or modified to the extent that its safety or effectiveness could be affected. Such change or modification could relate to the design, material, chemical composition, energy source, manufacturing process, or intended use.” FDA
What is C-QUR™ Mesh?
“C-QUR™ Mesh is indicated for use in hernia repair, chest wall reconstruction, traumatic or surgical wounds, and other fascial surgical intervention procedures requiring reinforcement with a non-absorbable supportive material.” More information Atrium C-QUR is a mesh material that is used mainly in the surgical repair of hernias. It has also been used in chest wall reconstruction and in the repair of traumatic or surgical wounds. It is manufactured by Atrium Medical Corporation. The use of Atrium c qur has been found to cause serious injuries to some patients. As a result, legal action has been taken against the manufacturer in some instances. Patients may encounter adverse reactions to the product immediately or, more typically, after the product has been in use for some time.
How much of a settlement can I expect?
No one can predict the amount of settlement or judgment a victim will receive as a result of bringing a hernia mesh claim. The amount of a hernia mesh settlement in 2018 depends on the severity of pain and suffering and symptoms as well as:
- Amount of medical bills, medication costs and medical device expenses
- Number of revision surgeries or other surgical procedures
- The skill, expertise and aggressiveness of the hernia mesh victim’s medical device attorney
- The financial resources of the manufacturer to pay thousands of claims, Does the defendant have deep enough pockets
- The nature, extent and longevity of the pain and suffering of the victim
- other factors not set forth above
- Hundreds of mesh victims are searching the internet seeking justice and accountability for their suffering.
- Many of these victims are searching for the following keywords: Hernia mesh settlement 206, Mesh settlement 2017, hernia mesh settlement amounts, hernia mesh lawsuit 2017, hernia mesh lawsuit settlement amounts 2017, “know before you file hernia mesh lawsuit” and “average settlement for hernia mesh.”
History of the Atrium C-QUR
Atrium C-QUR is a brand of mesh that is utilized for the treatment and repair of a hernia. Hernias occur a portion of the intestine or nearby tissues force through a weakened portion of the nearby muscle or connective tissue. Surgical mesh is typically used of synthetic materials that is woven together to form a non-absorbable barrier that can be used in surgical procedures.
Mesh patches are not necessarily designed to provide a long-term solution but instead offer a basis for the body to grow tissue that will strengthen the area. However, medical complications including c-qur mesh complications can occur that may be very serious. One such complication occurs when the loops of the intestines adhere to the mesh or to each other. This can create a serious medical emergency or obstruction which requires immediate surgery. Victims across the United States are increasingly looking into whether they can file a c-qur mesh lawsuit. Many victims incorrectly believe that a c-qur mesh recall is needed to file a lawsuit. Other victims incorrectly believe that the lawsuits are a class action.
Symptoms of Adverse Reactions to Atrium C-QUR
Not everyone experiences problems with mesh implants. However, if a patient notices any adverse reactions, it is imperative to seek immediate medical attention. Your doctor will make a determination as to whether the mesh implant has failed or has caused or contributed to the complication.
- Pain or swelling
- Diarrhea or vomiting
- Recurrence of the hernia
- Mesh adherence to the intestines
- Bowel obstruction
- Damage to an organ, nerves or blood vessels
These complications may occur at any time after the original surgery has taken place. If the mesh material begins to break down before the body has naturally repaired the area, the individual will likely experience some complications. These may range from minor to severe, but often require additional surgery to repair the area. In some instances, complications can be life-threatening. The most common complications that occur with the use of Atrium C-QUR are migration and erosion.
Treatment for Mesh Implant Complications
There are various treatments that may be necessary for mesh implant complications. The University of Mississippi Medical Center, the treatment plan may include topical treatments, oral medications to treat pain or muscle spasms and injections to reduce inflammation and pain. Surgery is likely the most common method of treatment.
It is important to note that generally, mesh implants usually cannot be completely removed once they have been implanted. The body grows tissue in and around the mesh rendering it impossible to fully remove without causing major internal damage. Therefore, surgical repair methods must be used which may include partial removal and the further use of mesh if necessary.
The U.S. Food & Drug Administration, FDA, has provided communication regarding safety concerns for some types of mesh implants. Patients who experience complications from the use of surgical mesh should report the problem to the FDA through the MedWatch Adverse Event Reporting program. This may be done online or by mail or fax. Doctors are also encouraged to report complications. It is important that all those who experience medical problems report them to the FDA so that proper steps are taken to prevent further injuries from occurring. The FDA may require a company to recall products that are reported to be dangerous to patients.
Recall of hernia Mesh Implants
In 2013 Atrium Medical Corporation issued a recall of their C-QUR products with lot numbers 10405513 and higher. The recall was made due to humidity concerns with product packaging. When exposed to high levels of humidity the fish oil coating on the mesh can cause the product to adhere to the packaging. The recall applied to packaging concerns only and did not directly address medical problems associated with surgical use.
Defective product liability
Unfortunately, there have been complications reported that involve defects in the product after it is implanted in the body. Those who have suffered a complication due to a faulty Atrium C-QUR mesh implant should report the problem to the FDA. The physician should also report the injury. Legal action may be necessary against the manufacturer because of the failure to warn of possible injuries and complications and their lack of response in resolving the reported problems. The company should be responsible for any injuries that occurred because of a defect in their product or lack of warning to patients.
Litigation History and Current Status- c qur mesh
Lawsuits have been filed against Atrium Medical Corporation for poor design of the product and for inadequate manufacture. The company has a duty to fully test their products before they are sold, and they must also warn consumers of the potential risks involved in using the products. A number of lawsuits have been filed against AMC for injuries that resulted from the use of C-QUR mesh products. These lawsuits have not yet been resolved. You may be able to file a lawsuit if you had hernia repair which utilized Atrium C-QUR after May 2006 and suffered complications that required additional surgery or other medical treatment.
How to Take Legal Action
Those who have suffered medical complications due to the use of Atrium c qur mesh may be entitled to compensation. Litigation may be needed in order to receive compensation for medical costs, lost wages, pain and suffering, and other expenses directly caused by faulty mesh implants. A diagnosis must show that the patient’s injury is due to the use of an Atrium C-QUR mesh implant. Patients should obtain medical records that provide information regarding the specific type of mesh implant that was utilized in their original hernia surgery. A patient should take action as soon as possible after learning about the injury because there are legal time limits to file a legal claim. Multiple cases may be combined in a class action lawsuit.
C-Qur settlement 2020?
No hernia mesh attorney can predict when and if there will be a C-Qur settlement in 2021 or at anytime in the future. Also, no hernia mesh law firm or surgical mesh lawyers can state what is the average Atrium C-Qur hernia mesh settlement. These C-Qur lawsuits are now multi-district litigation pending in New Hampshire Federal Courts.
Atrium C-QUR™ hernia mesh lawsuit
(Please note that this post focuses on lawsuits pending in Federal Court. A hernia mesh Lawsuit could also be filed in state courts)
Types of lawsuit: Multi District Litigation
Court deciding claims: UNITED STATES DISTRICT COURT FOR THE DISTRICT OF NEW HAMPSHIRE.
The presiding justice: Judge Landya McCafferty
Federal Court address: 55 Pleasant Street Room 110 Concord, NH 03301,
Phone number of Court: 603.225.1423.
Case caption for hernia mesh lawsuit: In Re: Atrium Medical Corp. C-QUR™ Mesh Products Liability Litigation (MDL No. 2753)
MDL Docket No: Case No.: 16-md-2753 LM
List of individual cases: Listing of Individual Cases as of August 28, 2017
510(k) Premarket Notification: Applicant- Atrium Medical Corp.
UNITED STATES JUDICIAL PANEL on MULTIDISTRICT LITIGATION: Transfer order
“On the basis of the papers filed and hearing session held, we find that these actions involve common questions of fact, and that centralization in the District of New Hampshire will serve the convenience of the parties and witnesses and promote the just and efficient conduct of this litigation. All the actions share common factual questions arising out of allegations that defects in defendants’ C-Qur mesh products incite an allergic or inflammatory response that causes severe complications. All the actions involve factual questions relating to whether C-Qur mesh was defectively designed or manufactured, whether defendants knew or should have known of the alleged propensityof C-Qur mesh to result in an allergic or inflammatory response, and whether defendants provided adequate instructions and warnings with the mesh. These common factual issues are sufficiently complex to merit centralized treatment. Centralization will eliminate duplicative discovery; prevent inconsistent pretrial rulings; and conserve the resources of the parties, their counsel, and the judiciary.” UNITED STATES JUDICIAL PANEL on MULTIDISTRICT LITIGATION IN RE: ATRIUM MEDICAL CORP. C-QUR MESH PRODUCTS LIABILITY LITIGATION MDL No. 2753 TRANSFER ORDER
District of New Hampshire’s Local Rules
(Appendix A for Supplemental Rules for Electronic Case Filing)
MDL Rules & Procedures (source)
Case Manager/Docketing Clerk:
Back-up case manager:
CM/ECF Helpdesk: (603) 225-1423 Option 7
Case management orders:
““The actions listed in Attachment A are consolidated for pretrial purposes. Any “tag-along” actions later
removed to or transferred to this court, or directly filed in this court, will automatically be consolidated with this action without the necessity of future motions or orders. This consolidation, however, does not constitute a determination that the actions should be consolidated for trial, nor does it have the effect of making any entity a party to any action in which he, she, or it has not been named, served, or added in accordance with the Federal Rules of Civil Procedure.”
“In order to eliminate delay and to promote judicial efficiency, any plaintiff whose case would qualify for transfer to MDL No. 2753 under the Judicial Panel on Multidistrict Litigation’s December 8, 2016 transfer order (doc. no. 1) may file his or her complaint directly in MDL No. 2753 in this court. Defendants reserve the right to object to the inclusion of any such action in this MDL.” (Direct Filing and Waiver of Service)
Hernia mesh lawsuit settlements: There has been no global C-Qur hernia mesh settlement 2021. No hernia mesh lawyer can state an average C-Qur hernia mesh settlement 2021.
Know before file hernia mesh lawsuit: A hernia mesh victim should carefully search for the best hernia mesh law firm. The best hernia mesh attorneys will be from large firms with the resources and experience to litigate these complex matters. The reputation of a top hernia mesh law firm will help the defective medical device victim get the hernia mesh settlement they deserve.
Hernia mesh lawsuit settlement amounts: There is no way that any hernia mesh lawyers or mesh law firms can adequately inform you of the amount of mesh settlement you will receive. If you search google you will see a lot of searches about “hernia mesh settlement 2021” None of these product liability, defective and unsafe hernia mesh posts can truthfully inform you of the settlement for your hernia mesh claim.
Hernia mesh lawsuit symptoms:
“Based on FDA’s analysis of medical device adverse event reports and of peer-reviewed, scientific literature, the most common adverse events for all surgical repair of hernias—with or without mesh—are pain, infection, hernia recurrence, scar-like tissue that sticks tissues together (adhesion), blockage of the large or small intestine (obstruction), bleeding, abnormal connection between organs, vessels, or intestines (fistula), fluid build-up at the surgical site (seroma), and a hole in neighboring tissues or organs (perforation).
The most common adverse events following hernia repair with mesh are pain, infection, hernia recurrence, adhesion, and bowel obstruction. Some other potential adverse events that can occur following hernia repair with mesh are mesh migration and mesh shrinkage (contraction).
Many complications related to hernia repair with surgical mesh that have been reported to the FDA have been associated with recalled mesh products that are no longer on the market. Pain, infection, recurrence, adhesion, obstruction, and perforation are the most common complications associated with recalled mesh. In the FDA’s analysis of medical adverse event reports to the FDA, recalled mesh products were the main cause of bowel perforation and obstruction complications.” FDA